august 2010, vol 3, no 5

Fostering a Dialogue to Improve Patient Care & Outcomes

Submit your cases online today at

www.myelomacases.com

AUGUST 2010 www.JOMCC.com VOL 3, NO 5

Inside

Oncology Drug CodesMedications used for the treat-ment of colorectal cancerpage 24

COMPLIMENTARY

CME CREDITMultidisciplinary approach tometastatic nonseminomatous germ-cell testis tumorspage 16

The Health Care and EducationReconciliation Act—ie, “health-care reform” —essentially “limped

to the finish” line on March 30, 2010,after “endless complications” that includ-ed the restructuring of one sixth of theUS economy, the huge expense of thelegislation, and the politicalization of theissues, said Steven K. Stranne, MD, JD, a physician and lawyer with PolsinelliShughart PC, in their Washington,DC–based office.But this heroic effort is far from the

end of the process, he added. Healthcarereform legislation simply provides an out-line for change, leaving many “gaps andambiguities” yet to be tackled. Federalagencies must fill in many of the impor-tant details through rulemaking andguidance documents that will be imple-mented on a rolling basis.“Healthcare reform continues to be a

changing target,” said Stranne, whodescribed how the legislation will affectoncology at the meeting’s “Reim -bursement Forum.”

CONFERENCE NEWS: ASCO

Cancer Care in the Era ofReformBy Caroline Helwick

Continued on page 4Left to right: Tiffany Raroha, MSW; William J. Tester, MD, FACP; LisaJablon, MD, FACS; and Lawrence J. Solin, MD, FACR, FASTRO.

Continued on page 28

Albert Einstein CancerCenter Joins the NCCCPBy Dawn Lagrosa

This past April, Albert Einstein Cancer Center was selected to jointhe National Cancer Institute (NCI) Community Cancer CentersProgram (NCCCP), which in the words of William J. Tester, MD,

FACP, medical director of Einstein’s Cancer Center, offers “an oppor-tunity to bring more resources to our patients.”Using $40 million in funding from the American Recovery and

Reinvestment Act, the NCCCP has expanded its number of commu-nity-based sites from 16 to 30. Einstein was one of 14 medical cen-ters chosen to expand the program.NCCCP is designed to create new research opportunities across

the cancer care continuum from screening and treatment to follow-upand sur vivorship care. NCCCP cancer centers are also tasked toreduce healthcare disparities and improve the quality of care at com-munity hospitals.

Reducing disparitiesWith its mission of delivering high-quality care, Albert Einstein

Cancer Center (Einstein) has already been working to overcome thosebarriers that contribute to healthcare disparities. Located in northPhiladelphia, Einstein serves a diverse population that includes largeAfrican-American, Hispanic, and Asian subpopulations. In this urbansetting, Einstein delivers care to patients from multiple socioeconom-

FINANCING

Equipment Financing:Weighing the OptionsAn interview with Peter S. Myhre

By Dawn Lagrosa


©2010 Green Hill Healthcare Communications, LLC

Medical equipment, especiallyoncology and radiation equip-ment, is an integral element in

providing patients with high-quality care.However with the high cost of suchequipment, the decision on how tofinance these expenditures can be com-plex. In an interview with Journal ofMultidisciplinary Cancer Care, Peter S.Myhre, senior vice president, HealthcareFinancial Services Division, Wells FargoEquipment Finance, explains the variousfinancing options available, detailing the

advantages and disadvantages of the dif-ferent types of products. In addition, heoffers advice on what to expect whenapplying for credit as well as what to lookfor in a lender.

What are the advantages and disad-vantages of lease and loan options forequipment financing?There are advantages and disadvan-

tages to both a lease and a loan. The deci-sion whether to lease or obtain a loanneeds to be made in light of each health-

Psychosocial IssuesA team approach to psychosocial carepage 20

Clinical PathwaysSelecting the appropriatepathways programpage 10

CANCER CENTER PROFILE

BenchmarkingBenchmarking performance ina physician-owned practicepage 22

Conference NewsImproving health literacyand numeracypage 7

Novel agent has strikingactivity in lung cancer subsetpage 8

To learn more about Balloon Kyphoplasty, visit our website

at www.kyphon.com.

KYPHON® Balloon Kyphoplasty

The complication rate with KYPHON® Balloon Kyphoplasty has been demonstrated to be low. As with all surgical procedures, there are risks associated with the procedure, including serious complications, and though rare, some of which can be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product.© 2009 Medtronic Spine LLC. All Rights Reserved. 16003611_001 rev 1

Tom Callaghan experienced debilitating pain due to spinal fractures caused by multiple myeloma. He underwent a minimally invasive procedure, Balloon Kyphoplasty, to treat the spinal fractures.

“After my balloon kyphoplasty, I’m walking pain-free again.”

EDITOR-IN-CHIEFMark J. Krasna, MDSt. Joseph Cancer InstituteTowson, MDSurgical Oncology

John F. Aforismo,BSc Pharm, RPh, FASCPRJ Health SystemsInternationalWethersfield, CTOncology Pharmacy

Elizabeth Bilotti,RN, MSN, APNcJohn Theuer CancerCenterHackensack UniversityMedical CenterHackensack, NJOncology Nursing

Nicole A.Bradshaw, MS,CICMountain States TumorInstituteNampa, IDOncologyAdministration

Anna M.Butturini, MDChildren’s Hospital Los AngelesLos Angeles, CAMedical Oncology

Minsig Choi, MDG. V. Montgomery VA Medical CenterJackson, MSMedical Oncology

Steven L. D’Amato,RPh, BCOPMaine Center for CancerMedicine Scarborough, MEOncology Pharmacy

Scott E. Eggener,MDUniversity of ChicagoChicago, ILSurgical Oncology

Beth Faiman, RN,MSN, APRN,BC, AOCNCleveland Clinic TaussigCancer InstituteMayfield Heights, OHOncology Nursing

Mehra Golshan,MDDana-Farber CancerInstituteBoston, MASurgical Oncology

Patrick A.Grusenmeyer,ScD, FACHEChristiana Care HealthSystemNewark, DEOncologyAdministration

Marilyn Haas,PhD, CNS, ANP-BCCarePartnersAsheville, NC Oncology Nursing

Dawn Holcombe,MBA, FACMPE,ACHEDGH ConsultingSouth Windsor, CTOncologyAdministration

Patricia Hughes,RN, MSN, BSN,OCNPiedmont HealthcareAtlanta, GAOncology Nursing

Arun Kumar, MDVA Medical CenterHuntington, WVMedical Oncology

Shaji K. Kumar,MDMayo ClinicRochester, MNHematology-Oncology

Terry Macarol,RT(R)(M)(QM)Advocate Health CareOak Brook, ILRadiological Technology

Patrick Medina,PharmD, BCOPOklahoma UniversityCollege of PharmacyOklahoma City, OKOncology Pharmacy

Patricia Molinelli,MS, RN, APN-C,AOCNSSomerset Medical CenterSomerville, NJOncology Nursing

Judy A. Olson,RT(R), RDMSSt. Luke’s MountainStates Tumor InstituteBoise, IDOncologyAdministration

Nicholas Petrelli,MDHelen F. Graham Cancer CenterChristiana Care Health SystemNewark, DESurgical Oncology

Greg Pilat, MBAAdvocate Health CareOak Brook, ILOncologyAdministration

Cristi Radford,MS, CGCSarasota MemorialHospitalSarasota, FLGenetic Counseling

Ritu Salani, MDOhio State UniversityMedical CenterColumbus, OHMedical Oncology

Andrew Salner,MDHartford RadiationOncologists AssociationHartford, CTRadiation Oncology

Timothy G. Tyler,PharmD, FCSHPComprehensive CancerCenter Desert RegionalMedical CenterPalm Springs, CAOncology Pharmacy

Gary C. Yee,PharmD, FCCP,BCOPUniversity of NebraskaMedical CenterOmaha, NEOncology Pharmacy

Burt Zweigenhaft,BSBioPharma Partners LLCNew York, NYManaged Care

Editorial Board

www.jOmcc.com august 2010 I VOL 3, NO 5 1

august 2010 • VOL 3, NO 5

PUBLISHING STAFFPublisherPhilip [email protected] DirectorKaren [email protected] EditorDawn [email protected], Client ServicesJohn W. [email protected]

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Journal of Multidisciplinary Cancer Care® (ISSN # 1949-0321) is published 8 times a year by Green Hill HealthcareCommunications, LLC, 241 Forsgate Drive, Suite 205C,Monroe Twp, NJ 08831. Telephone: 732.656.7935. Fax:732.656.7938. Copyright ©2010 by Green Hill HealthcareCommunications, LLC. All rights reserved. Journal ofMultidisciplinary Cancer Care® is a registered trademark ofGreen Hill Healthcare Communications, LLC. No part ofthis publication may be reproduced or transmitted in anyform or by any means now or hereafter known, electronicor mechanical, including photocopy, recording, or anyinformational storage and retrieval system, without writtenpermission from the Publisher. Printed in the United Statesof America.

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CONTENTS

Iam excited to talk to youabout two new opportuni-ties for our patients. The

National Cancer Institute(NCI) Community CancerCenters Program (NCCCP)has expanded research benefit-ting patients at its 16 memberhospitals and added 14 newhospitals to its current net-work, for a total of 30 sites in22 states.As one of the program’s

principal investigators (at St.Joseph Cancer Institute, Tow -son, Maryland), I welcome the

new members to our group. This opportunity to collabo-rate and share knowledge with cancer professionals fromdiverse regions of our country fills me with anticipation asto what I will learn from them. As this month’s profiledemonstrates, these new member centers are equallyexcited, already planning ways to enhance services fortheir patients.Research aspects of the program are also moving for-

ward. At the close of the 3-year pilot period, NCCCP cen-ters continue to build the infrastructure for increasing

minority accrual to NCI clinical trials and collect prospec-tive data to determine the impact of multidisciplinaryclinics on patient outcomes, including time to treatment,patient satisfaction, and survival. The NCI will be releas-ing our findings at the end of the year.Of course, much is happening in the world of cancer

care. Many of you likely attended the annual meeting ofthe American Society of Clinical Oncology (ASCO), atwhich you had to choose presentations to attend, missingothers given at the same time. We hope our coverage ofsome key presentations help fill that gap. The ASCO meeting’s reimbursement forum highlight-

ed challenges and trends in how cancer care will be paidfor in the future: integrated care; bundling payment forepisodes of care; risk-sharing among providers; improvedcoordination among providers; formation of networks ofproviders; and the development of accountable careorganizations. One such payment design is clinical path-ways, but what pathways programs really are is an area ofconfusion for many. In this issue, Dawn Holcombe offersadvice on how to choose a model that works for you andyour payer mix. As always, I hope this issue of the Journal of

Multidisciplinary Cancer Care benefits your practice andprovides ideas on how to move it forward. We look for-ward to your feedback.

FEATURE ARTICLES

7 Conference News: ASCOAccess to investigational agents has been simplifiedImproving health literacy and numeracyNovel agent has striking activity in lung cancer subsetBevacizumab lengthens progression-free survival in advanced ovarian cancer, effect on overall survival uncertainNew monoclonal antibody treatment offers hope for treatment of metastatic melanomaBiologic effective against rare thyroid cancer

10 Clinical PathwaysClinical pathways programs: confusing choices for payers and physicians.Part 1: selecting the appropriate pathways program

16 Continuing EducationMultidisciplinary approach to metastatic nonseminomatous germ-cell testis tumors

20 Psychosocial IssuesA team approach to psychosocial care

22 BenchmarkingBenchmarking performance in a physician-owned practice

DEPARTMENTS

24 Oncology Drug CodesMedications used for the treatment of colorectal cancer

26 Recent FDA Approvals

Mark J. Krasna, MDST. JOSEPH CANCERINSTITUTEEditor-in-Chief

Green Hill Healthcare Communications LLCGreen Hill Healthcare Communications, LLC HGYour Innovative Partners in Medical Media™

™

241 Forsgate Drive, Suite 205CMonroe Twp, NJ 08831

INTRODUCTION

2 august 2010 I VOL 3, NO 5 www.jOmcc.com

US ONCOLOGY OFFERS THE BEST OF BOTH WORLDS.

With the United Network of US Oncology, your independent practice has every opportunity

to grow and thrive. Because we know each practice is different, we’ve developed a new range

of options that let you choose the solutions that best fit your needs. After all, independence

doesn’t mean you have to go it alone.

To learn more about the United Network of US Oncology, visit usoncology.com/MCC

Copyright © 2010 US Oncology, Inc. All rights reserved.

Comparative effectivenessresearch expandedComparative effectiveness research

(CER) is part of the national strategy onquality improvement and is a cost-con-tainment strategy as well. Beyond the$1.1 billion in stimulus funding, goingforward, the healthcare reform legisla-tion will fund the program by taxing pri-vate insurers and Medicare per capita.The legislation also takes CER a step

further, by linking the research findingsto provider incentives, and it furthersthe commitment to CER by creatingthe new Patient-Centered OutcomesResearch Institute (to oversee CERwith an independent board of publicofficials, private sector members, andadvisory groups) and by creating a long-term funding mechanism. “While there is support, it is also con-

troversial, and there are opposing views.Some policy makers see the potential

for dramatic cost-savings in the futuredue to alignment of CER with coveragepolicies and reimbursement. Others fearrationing based on CER, although thelegislation’s language attempts to safe-guard against this,” he said.

Independent Payment AdvisoryBoard to make the tough decisionsA controversial Medicare cost-con-

tainment strategy is the creation of anIndependent Payment Advisory Board(IPAB). The IPAB is a 15-memberboard appointed by the President (sub-ject to consent by Congress) designed toinsulate tough decisions regarding futurepayment reductions from the politicalsystem. Its initial recommendations areapplicable to calendar year 2014.In years when Medicare costs are pro-

jected to be unsustainable by theCenters for Medicare & MedicaidServices (CMS) actuary, IPAB propos-

als will take effect unless Congressenacts alternative measures thatachieve the same savings as the IPABproposals. IPAB is prohibited from mak-ing proposals that ration care, raisetaxes, raise Part B premiums, or changeMedicare benefits, eligibility, or low-income cost-sharing standards. The IPAB is an attempt to control

the growth of Medicare but remainscontroversial. “IPAB proposals could setaside established payment methodolo-gies…which could result in significantcuts for professional services, drugs, andother items,” Stranne noted.

What else is comingAlternative payment methodologies

will also be part of healthcare reformlegislation. The new Innovation Centerwithin CMS has the authority to testand expand the use of innovativeapproaches to reimbursement. The

emphasis will be on integrated care;bundling payment for episodes of care;risk-sharing among providers; improvedcoordination among providers; forma-tion of networks of providers; and thedevelopment of accountable careorganizations.The American Society of Clinical

Oncology (ASCO) is supporting legis-lation to provide separate reimburse-ment for treatment planning, advancecare consults, and patient educationabout treatment. This was not part ofthe initial healthcare reform legislation.This concept is reflected through a

demonstration project offered throughthe Innovation Center. The projectaims to provide financial incentives fortreatment planning and follow-up careplanning in the context of cancer careguidelines and to identify gaps in appli-cable quality measures.“ASCO will work with CMS on

implementing this demonstration proj-ect, and will continue to advocate forseparate reimbursement of such servic-es,” Stranne said.

More money for clinical trialsA positive impact on oncology

should be felt through mandated reim-bursement for the routine costs of clini-cal trials. (Coverage of experimentalproducts or data collection requiredsolely for the trial is not required.)There are still, however, several out-standing issues: (1) the inadequate per-case reimbursement for participation infederally funded trials (currently cover-ing just one third of the cost); (2) theneed to secure adequate research fund-ing for the National Institutes of Health(NIH) and National Cancer Institute(NCI) for fiscal year (FY) 2011 andbeyond; and (3) the need to address sus-tainability once the 2-year infusion ofresearch funding from the AmericanRecovery and Reinvestment Act ends.Stranne cautioned that these funding

proposals may fall prey to the “difficultmood” on Capitol Hill following thehealth care reform legislation, “thoughcancer research continues to attractfavorable bipartisan support,” he added.What is encouraging is that the

President’s budget reflects a 3.2%increase for the NIH in FY 2011, and acorresponding 3.16% increase for theNCI, representing $163 million. “ThePresident’s proposed increase indicatesthis is a priority to the administration,though funds ultimately appropriatedby Congress may differ,” he said. l

www.jOmcc.com4 august 2010 I VOL 3, NO 5

Conference News

The Era of Reform ...continued from cover

Reimbursement Challenges for OncologyPracticesSGR a major sticking pointOncology practices are relatively

unscathed by direct cuts under health-care reform; however, they face reim-bursement challenges that the legisla-tion does not address, said Steven K.Stranne, MD, JD, a physician andlawyer with Polsinelli Shughart PC, intheir Washington, DC–based office,and Joseph Bailes, MD, of TexasOncology in Austin, who is chair ofthe American Society of ClinicalOncology’s (ASCO) GovernmentRelations Council. Stranne cited these challenges for

oncology practices: • More “underwater drugs,” ie, thosereimbursed at rates lower than thepurchase cost

• The combined effect of inadequateplus unrecognized reimbursementfor services provided

• Growing administrative burdensplaced on practices

• Reductions in chemotherapy ad -ministration codes planned to bephased-in from 2010 to 2013 inphysician office settings

• Increasing unwillingness by privatepayers to absorb un derpaymentsfrom public programs and unin-

sured patients• Uncertainty of the sustainablegrowth rate (SGR) situation.

Need to fix SGRThe lack of a permanent fix for the

SGR “is the elephant in the room”when costs are discussed, said Stranne.“Individual members of Congressacknowledge their frustration andembarrassment at not having a perma-nent fix,” yet as a group they have notfound a solution, he said. Bailes referred to the “political prob-

lems” associated with the SGR fix.“The congressional interventions overthe years have merely delayed theimpact of the SGR mechanism ratherthan reset the base. As a result, thecuts from prior years have continued toaccumulate,” he said. “If Congress failsto act now, there will be a 21.3% cutimposed under the SGR mechanism.” ASCO continues to advocate for a

permanent legislative fix that removesthe accumulation of delayed cuts fromthe mechanism. To date, Congress hasbeen unable to enact such legislation,and the cost of enacting a permanentfix has risen to approximately $250 billion, according to Bailes. This has

resulted, he said, in the situation facingphysicians in 2010: “month-to-monthpatches enacted by Congress.” In a letter to The New York Times

(June 24, 2010), George Sledge, MD,and Allen Lichter, MD, who are,respectively, president and chief exec-utive officer of ASCO, spoke for theoncology community’s frustrationwhen they wrote, “The field of oncol-ogy is undergoing serious upheavalnow that reductions in Medicare reim-bursement rates are in full effect, to thedetriment of patient access to care. “Reimbursement for many drugs is

less than the actual cost of buying them.Many physicians, unable to cover costs,are sending Medicare patients to otherfacilities for care, and some are closingtheir doors altogether…. Physiciansneed to be reimbursed fully and fairlyfor the actual cost of providing care topatients. Unless the Medicare reim-bursement system is fixed, more prac-tices will be forced to shut down.” On June 24, the House of Repre -

sentatives voted once again—this time,417 to 1—to delay the cut in Medicarepay for physicians through November30, but by December 1, the mandatedSGR cut is expected to occur. l

ASCO

The following articles are based on presentations at the 46th Annual Meeting of theAmerican Society of Clinical Oncology held in Chicago, Illinois, June 4-8, 2010.

Conference News continued on page 7

Totect® Kit (dexrazoxane) for injection is for intravenous infusion only. Totect is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.

TWO PRICE OPTIONS AVAILABLE

First and only FDA approved treatment for anthracycline extravasation.

Supplied as a convenient and accessible complete three day treatment kit for single patientuse, which should be proactively stocked on-site and infused as soon as possible andwithin 6 hours of an anthracycline extravasation.

Demonstrates 98% overall e�cacy based on two biopsy-con�rmed clinical trials1,2 inreducing or avoiding surgical intervention (i.e., surgical debridement, plastic surgery and their related costs), thereby reducing postponement of a patient’s chemotherapy treatments and the avoidance of long-term consequences. Cited in nursing guidelines.3,4 Extravasation management is now a chemotherapy administration safety standard.5

For more information, call 866-478-8274 or visit our website at www.totect.comTo order Totect®, contact one of our authorized distributors.

ASD Healthcare(800) 746-6273

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US Oncology(888) 987-6679

1 Mouridsen HT et al. Treatment of anthracycline extravasation with savene (dexrazoxane).Results from two prospective clinical multicentre studies. Ann Oncol 2007; 18:546-550.2 Totect® package insert.3 Polovich M, White JM, Olsen, M (eds.). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (ed 3). Pittsburgh, PA, Oncology Nursing Society, 2009.4 Alexander M, Corrigan A, Gorski L, Hankins J, Perucca R. (eds). Infusion Nurses Society Infusion Nursing an Evidence-Based Approach (ed 3). Boston, MA, Infusion Nurses Society, 2009.5 Jacobsen J., et al. American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards. Oncology Nursing Forum, 2009; 36:651-658.© 2010 Topotarget USA. All rights reserved. TOT0111/7-10Totect and its logo mark are registered trademarks of Topotarget A/SImage is copyright © Photo Researchers, Inc.

ARE YOU PREPARED?

Rx onlyTotect® is a registered trademark of Topotarget A/SUS Patent No. 6,727,253B2NDC 38423-110-01

Manufactured by:Ben Venue Laboratories, Inc.Bedford, OH 44146

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Manufactured for:Topotarget A/SFruebjergvej 3DK-2100 CopenhagenDenmark

TOT0111/7-10© 2010 Topotarget USA

www.totect.com

Totect® – Brief prescribing information Please refer to the package insert for full prescribing information. Each Totect carton contains 10 vials of Totect® (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent. Indication: Treatment of extravasation resulting from IV anthracycline chemotherapy. Dosage and administration: Totect is a cytotoxic drug. Vial contents must be mixed and diluted before use. Totect should not be mixed or administered with any other drug during the infusion. Administration of Totect should begin as soon as possible and within 6 hours following the anthracycline extravasa-tion. Totect should be given as an intravenous (IV) infusion once daily for 3 consecutive days. The dose of Totect is based on the patient’s body surface area: day one, 1000 mg/m2; day two, 1000 mg/m2; day three, 500 mg/m2. For patients with a body surface area of > 2 m2, a dose of 2000 mg should be given on days 1 and 2, and a dose of 1000 mg should be given on day 3. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the �rst day. The Totect dose should be reduced 50% for patients with creati-nine clearance values of <40 mL/minute. Cooling procedures such as ice packs should be removed from the a�ected area at least 15 minutes prior to Totect administration. Totect (dexrazoxane for injection) must be reconstituted with diluent supplied in the carton. The patient’s Totect dose is diluted in 0.9% 1000 mL NaCl prior to administration. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guide-lines on this subject have been published.3-5 Direct contact of Totect® with the skin or mucous membranes prior to and following reconstitution should be avoided. If contact occurs, wash immediately and thoroughly with water. Contraindications: None.Warnings and Precautions: Myelosuppression: treatment with Totect is asso-ciated with leukopenia, neutropenia, and thrombocytopenia. Hematological monitoring should be performed. Use in Pregnancy: Pregnancy Category D. Totect can cause fetal harm when administered to a pregnant woman. There is no adequate information about the use of Totect in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Adverse reactions: The most common adverse reactions (≥ 16%) are nausea, pyrexia, injection site pain and vomiting.

Drug Interactions: No drug interactions have been identi�ed. Based on anecdotal reports concurrent use of topical dimethyl sulfoxide (DMSO) at the site of tissue injury may reduce the benefit of Totect. Additionally, nonclinical studies using a mouse model that simulates extravasation of anthracyclines has shown that concomitant treat-ment with topical DMSO decreases the efficacy of systemic dexrazoxane. Use in Speci�c Populations: Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of drug to the mother. Renal Impairment: Reduce the Totect dose by 50% In patients with creatinine clearance values <40 mL/min. Pediatric Use: The safety and e�ectiveness of Totect in pediatric patients have not been established. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Be-cause elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Overdosage: There are no data on overdosage. There is no known antidote for dexrazoxane. Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of dexrazoxane has not been investigated. Nevertheless, a study by the National Cancer Institute has reported that long term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice. Dexrazoxane was not mutagenic to bacteria in vitro (Ames assay), but caused signi�cant chromosomal aberrations in mammalian cells in vitro. It also increased the formation of micronucleated polychromatic erythrocytes in mice. Thus, dexrazoxane is mutagenic and clastogenic. The possible adverse effects of Totect on the fertility of humans and experimental animals, male or female, have not been adequately studied. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (about 1/5 the human dose on a mg/m2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (about half the human dose on a mg/m2 basis).

august 2010 I VOL 3, NO 5 7www.jOmcc.com

Conference News

Access to Investigational Agents Has Been SimplifiedBy Caroline Helwick

The American Societyof Clinical Oncology(ASCO) and the US

Food and Drug Admin -istration (FDA) jointly an -nounced the launch of anew set of online resourcesto help physicians fullyunderstand the require-ments for expanded accessto investigational drugs.These resources are nowavailable to all oncologists, free ofcharge, through ASCO’s physician

education website, ASCOUniversity (www.university.asco.org).If there is scientific evi-

dence to suggest that treat-ment with an unapprovedtherapy may be beneficialand the patient has ex -hausted all other treat-ment options, and is noteligible for a clinical trial,the FDA-regulated expand-

ed access program gives physiciansaccess to investigational agents.

“Many patients do not meet the oftenstrict criteria for clinical trials. TheFDA’s updated expanded access pro-gram provides a chance for access toinvestigational agents, but many physi-cians and patients have been unclearabout its requirements. We were pleasedthat the FDA offered us the opportuni-ty to help develop comprehensive edu-cational materials to assist oncologistsin understanding this process,” saidASCO president George W. Sledge, Jr,MD, of Indiana University.The online modules introduce all the

expanded access programs available; out-line the process for requesting expandedaccess from the physician, FDA, industry,and Institutional Review Board perspec-tives; and explain physicians’ legalresponsibilities for treating patients withan investigational agent outside of a clin-ical trial. Links to key references andresources as well as helpful resources touse with patients are also available.Included in the modules are a glossary, anExpanded Access request checklist, andhelpful templates to ease the develop-ment of related paperwork. l

Physicians must lower the demandsand complexity of health informa-tion to overcome the barriers to

health literacy and increase patientunderstanding and informed decision-making, according to a panel of expertschaired by Terry C. Davis, PhD, head ofthe Behavioral Science Unit of theFeist-Weiller Cancer Center, LouisianaState University Medical Center,Shreveport.Davis pointed out that the need is

very real. Citing the National ActionPlan to Improve Health Literacy releasedin May 2010 by the Office of DiseasePrevention and Health Promotion, shenoted that of English-speaking USadults, only 12% have proficient healthliteracy skills. In addition, approximate-ly 45% of high school graduates havelimited health literacy.Although overall only 21% of US

adults are at the lowest (5th grade)reading level, 43% of those on Medicaidand 44% of those on Medicare or withchronic disease read at that low level.1This means that these individuals,though not completely illiterate, arefunctionally illiterate, stated Davis.And numeracy is a bigger problem thanreading, Davis explained, citing a studyof 200 primary care patients thatshowed that 78% read at ≥9th gradelevel but only 37% had math skills atthat level.2The impact of low literacy leads to

“poorer health choices, riskier healthbehaviors, less use of preventive servic-es, more delayed diagnosis, more hospi-talization with longer stays, poorerhealth management, and poorer physi-cal and mental health,” noted Davis,who believes that the solution, “is real-ly up to us.”As part of this solution, Davis high-

lighted the importance of creating

health information that is accurate,accessible, and actionable. She offeredthese tips to overcome literacy barriers: • Ensure a user-friendly environment(check-in, forms, signs, personnel)

• Avoid medical jargon, use living-room language

• Limit information—write brief take-home information

• Repeat and summarize information• Write precise prescriptions and re -view medication instructions

• Use pictures, teaching tools (pam-phlets, brown bag meds)

• Teach back/show back to confirmunderstanding.

She also recommended the “Tell Me3” strategy for limiting information3:• Diagnosis —What is my problem?• Treatment—What do I need to do?• Benefit/Context—Why is it impor-tant that I do this?

Written communicationWritten communication needs to be

easily understood. Focusing on in -formed consent forms, Cathy A. Coyne,MPH, PhD, Department of Community

Medicine, West Virginia University,Morgantown, discussed how there ismore to making a form easier to readthan just reducing the number of multi-syllabic words and shortening the sen-tences. Coyne and her colleagues onWest Virginia University’s InstitutionalReview Board have found that format-

ting can greatly impact readability.Modifications that had the highestimpact were incorporating more whitespace, inserting check boxes to promoteinteractivity with the form, increasingfont size (12 point), and “chunking” theinformation. In addition, they foundthat a treatment calendar with symbolsrepresenting the method of administra-tion “helps patients to understand theprotocol and keep in mind how they aregoing to be getting this medication,”Coyne said.

Numerical communicationFocusing on the challenge of over-

coming poor health numeracy, AngelaFagerlin, PhD, a research assistant pro-fessor at the University of MichiganHealth System, Ann Arbor, showcasedways to present numerical informationthat can affect a patient’s treatmentdecisions. When it comes to frequencies versus

percentages, most patients find naturalfrequencies easier to understand thanpercentages. For absolute versus relativerisk, the same data can lead to differentactions. “If you are trying to inform your

patients, you want to use absolute riskpresentation…if you are trying to getsomebody to do something, relative riskpresentation works much better,” Fa -gerlin explained, careful to note thatshe would recommend “if you are goingto use the relative risk presentation, alsouse the absolute risk presentation.”

The choice of graphic can also affectpatients’ actions. Fagerlin and her col-leagues performed a study on graphicinformation, that compared various typesof graphs to determine which best con-veyed information to its readers. In acomparison of pie graphs, modified piegraphs (with number ticks included),pictographs (a matrix of 10 x 10 squares),and spark plug pictographs (horizontalcolored lines/squares), readers were askedthe gist of the information presented andthen specific verbatim knowledge, whichrequired them to select numbers directlyfrom the graphs.They found that for gist knowledge,

pie graphs worked very well (meannumber of correct responses out of twoquestions, 1.59); however, for verbatimknowledge, few readers were able to pullout the numbers (mean number of cor-rect responses out of four questions,0.12). Pictographs worked well for bothgist knowledge (mean number of cor-rect responses out of two questions,1.56) and verbatim knowledge (meannumber of correct responses out of fourquestions, 2.17).Incremental risk presentation can be

more difficult to explain to patients. Picto -graphs again can be helpful. Fagerlin rec-ommended presenting baseline risk in one color and highlighting the additionalrisk in another color. With this method,patients can see not only their total risk,but also how much (or little) is addedfrom their treatment options. l

References1. Evidence Report. Literacy and Health Outcomes.

Rockville, MD: Agency for Healthcare Researchand Quality; 2004. Publication No. 04-E007-2.

2. Rothman RL, Housam R, Weiss H, et al. Patientunderstanding of food labels: the role of literacy andnumeracy. Am J Prev Med. 2006;31:391-398.

3. Weiss BD. Health Literacy and Patient Safety: HelpPatients Understand. 2nd ed. Chicago, IL: AMAFoundation; 2007.

Improving Health Literacy and NumeracyBy Dawn Lagrosa

George W. Sledge, Jr, MD

Although overall only 21% of US adults are at thelowest (5th grade) reading level, 43% of those onMedicaid and 44% of those on Medicare or withchronic disease read at that low level.

Photo by © ASCO/Todd Buchanan 2010.

ASCO...continued from page 4



Conference News

Novel Agent Has Striking Activity inLung Cancer Subset By Caroline Helwick

In a phase 1 study in ad -vanced non–small-celllung cancer (NSCLC)

deemed worthy of a presen-tation at the plenary ses-sion, a multinational groupof investigators reportedimproved survival with anoral in vestigational agentstill unfamiliar to mostoncologists.Crizotinib (PF-1066),

an inhibitor of anaplastic lymphomakinase (ALK), tar gets a fusion proteincalled EML4/ALK, which drives tumorgrowth in 3% to 5% of all NSCLCpatients. In the study presented, crizo-tinib produced tumor shrinkage in 57%and prolonged remission in 72% ofheavily pretreated advanced NSCLCpatients with the ALK protein. “Our results were very impressive.

The majority of patientsresponded, often within thefirst 2 weeks of treatment,and the responses wereoften durable,” re portedYung-Jue Bang, MD, PhD,of Seoul NationalUniversity in South Korea.The data come from an

ongoing phase 1 first-in-human trial of patients withALK-positive NSCLC treat-

ed with crizotinib after their tumorsprogressed, often after multiple treat-ment regimens. Bang presented theresults from the first 82 patients.

Striking tumor shrinkage observed“Almost all patients had some degree

of tumor shrinkage, even though 59%of the patients had received at least twoprevious treatments,” Bang reported.

Objective responses were observed in57% of the cohort (63% when fiveunconfirmed partial responses areincluded), and in 80% who hadreceived no prior treatments foradvanced disease. The disease controlrate (response or stable disease at 8weeks) was 87%. At a median follow-up of 6.4 months,

median progression-free survival hadnot yet been reached but is projected tobe 72% at 6 months. Seventy-sevenpercent of patients remain on treat-ment, including seven patients for morethan 1 year, he said. Treatment-related adverse events in -

cluded nausea (52%), diarrhea (46%),vomiting (43%), and visual disturbance(42%), but virtually all were grade 1and they tended to resolve over thecourse of treatment. Based on these preliminary findings,

Bang maintained that “for patients withALK-positive NSCLC, crizotinib mayoffer a potential new standard of care.”According to Martin Edelman,

MD, of the University of MarylandGreenebaum Cancer Center, Bal t i -more, the paper’s invited discussant,crizotinib should provide a targetedapproach to patients ineligible forinhibitors of the epidermal growth fac-tor receptor (EGFR). A search forEML4/ALK mutations will likely beadded to the emerging strategy of test-ing for mutations in NSCLC, he said. Edelman predicted that crizotinib

may eventually change practice but thedrug is not yet commercially available.An on going phase 3 trial is likely to bepositive, “considering the results today,”he said, and the drug should become “a major treatment advance” for thissubset. l

Martin Edelman, MD

Bevacizumab in com-bination with chemo -therapy followed by

maintenance bevacizumabmonotherapy improves pro-gression-free survival (PFS)over chemotherapy alonein the treatment of ad -vanced ovarian cancers,said Robert A. Burger, MD.Advances in the treat-

ment of ovarian cancerhave been limited during the pastdecade. Standard therapy for ovariancancer had been surgery and chemo -therapy (carboplatin and paclitaxel).The new finding means that beva-cizumab with chemo therapy followedby continuation of bevacizumab aloneshould be considered as one standardoption in the frontline treatment ofadvanced ovarian cancer, said Burger.He presented results from a study of

1873 chemotherapy-naïve patients withadvanced epithelial ovarian, primaryperitoneal, or fallopian tube cancer whoalready had surgical debulkment.Patients were randomized to either:

• Six cycles of chemother-apy (carboplatin andpaclitaxel) followed byplacebo for an additional10 months (arm 1)• Six cycles of chemothera-py plus five cycles of beva-cizumab given concurrent-ly, followed by placebomaintenance (arm 2)• Six cycles of chemothera-py plus five cycles of beva-

cizumab given concurrently, fol-lowed by maintenance bevacizu -mab alone (arm 3).

After a median follow-up of 17.4months, the median PFS for women inarm 1 was 10.3 months. In women inarm 3, the median PFS was 14.1months, representing a 28% reductionin the risk of cancer progression ordeath, and a 39% improvement in thelikelihood of living longer without dis-ease progression.All patient subgroups based on age,

disease stage, and performance statushad improvement in PFS with con-comitant/continuation of bevacizumab

compared with chemotherapy alone orchemotherapy only with concomitantbevacizumab, said Burger, director,Women’s Cancer Center, Fox ChaseCancer Center, Philadelphia.Women in arm 2 did not show an

increase in PFS compared with chemo -therapy alone.

No differences emerged in overall sur-vival between the three arms, but the survival data are not yet mature, Burgerexplained.Adverse events with bevacizumab

were similar to previous studies of beva-cizumab. Women who received mainte-

nance bevacizumab in addition to theirchemotherapy had a higher rate of neu-tropenia than those treated withchemotherapy alone. Grade 4 or higherneutropenia occurred in 63.3% of thosereceiving maintenance bevacizumab inaddition to chemotherapy, comparedwith 57.7% of those receiving chemo -therapy alone.Grade 3 or higher pain, grade 3 or

higher hypertension, and grade 2 orhigher gastrointestinal events were alsomore common with maintenance beva-cizumab/chemotherapy compared withchemotherapy alone.Elizabeth A. Eisenhauer, MD, of the

National Cancer Institute of CanadaClinical Trials Group, offered thatchanging the standard of care foradvanced ovarian cancer based on thefindings of this study would be prema-ture. “A PFS gain of only 3.8 monthsmay not be meaningful to patients,” shesaid. The mature overall survival dataare needed before the full effect of beva-cizumab can be placed into a clinicalcontext. l


Bevacizumab Lengthens Progression-free Survivalin Advanced Ovarian Cancer, Effect on OverallSurvival UncertainBy Wayne Kuznar

Robert A. Burger, MD



Bevacizumab withchemotherapy followedby continuation ofbevacizumab aloneshould be considered as one standard option.



Clinical Pathways

Clinical Pathways Programs: Confusing Choicesfor Payers and Physicians. Part 1: Selecting theAppropriate Pathways ProgramBy Dawn Holcombe, MBA, FACMPE, ACHEPresident, DGH Consulting, South Windsor, Connecticut

Managed care payersseek oncology so -lutions that will

reduce both variation andcost. Oncology physiciansseek stability in their abilityto make decisions in thebest interest of their pa tientsand payer contracts that willallow cancer centers andcommunity offices to con-tinue to provide care.Both payers and physi-

cians are exploring programs, and theword “pathways” is often raised—buthow those pathways are defined and exe-cuted makes an enormous difference.Payers can choose some program

management options that don’t addresspathways at all, such as drug manage-ment, disease management, and oncol-ogy management. Most of these pro-grams are imposed from the outsideonto practicing oncologists and typical-ly result in very short-term savings, cre-ate tension between physicians andpayer, and have a difficult time provinga satisfactory return on investment afterthe first couple of years.Increasingly, both payers and physi-

cians are exploring the options offered byevidence-based clinical decision-makingthat lead to clinical pathways programs.However, there is great variation amongthe current programs, as well as widevariation in satisfaction on both sideswith current models. Confusion aboutthe choices and ideal construct for a clin-ical pathways program abound amongboth payers and physicians.In order to decide what model of

clinical pathways would work best for aspecific payer or physician practice, wemust first explore the five key differ-ences, and identify the seven key ques-tions/issues to consider before selectinga course of action.

Distinguishing characteristics ofclinical pathwaysClinical source and maintenance. First

and foremost, a viable clinical pathwaysprogram must be firmly grounded in evi-dence-based clinical information, basedinitially upon the clinical parametersfound in the National ComprehensiveCancer Network’s published clinicalguidelines, and must have undergone rig-orous clinical review by an experienced

body of physicians. Periodicreview must be planned toensure the pathways adaptwith the ever-changingbody of clinical knowledgethat defines oncology, yetthe program must requiresufficient evidence of proofbefore adoption.Demand a clear process

and timeline for the clini-cal review of any pathwaysor guidelines program.

Pathway definition.Clinical guidelinesare the accepted standard for appropri-ate alternatives for treatment of malig-nancies, yet the range of guideline alter-natives for any disease can be comparedwith an eight- or ten-lane highway.Selection of the highway lane for anygiven patient is up to the physician, andrequires little further consideration ofalternatives as long as the chosen treat-ment is part of the list of those describedas part of the clinical guidelines for thatdisease.

A true clinical pathway is increasing-ly clarified as the identification of onepreferred treatment for a given state andstage of disease, which has been selectedvia a rigorous clinical review of theappropriate clinical guideline alterna-tives and selected based first upon clini-cal efficacy, then toxicity profile, and,lastly, assuming comparability across thefirst two criteria, cost of treatment.A clinical pathways program will

always allow physician flexibility totreat with an off-pathway alternative,because there is no one preferred treat-ment that will be universally applicableto all cancer patients 100% of the time.The rigorous clinical review of alterna-tives and definition of clinical pathwaymust be conducted by actively practic-ing oncologists, with support from

oncology pharmacists, and should becompletely free of outside influenceinto the evaluation process. The scopeof a pathway should include not onlychemotherapy infusables/injectables,but also orals, biotherapies, supportivecare drugs, prognostic testing, and ideal-ly also radiation oncology treatments.Clinical trials should always be consid-ered an on-pathway choice.Expect a pathways program to list

one preferred treatment tailored toindividual states and stages of disease.Anything less is still just a guideline,not a pathway.Point of clinical decision-making.

Unless a pathways program is executedat the point of physician medical deci-sion-making (before selection of thepatient treatment), it is not part of thedecision-making process and becomesan administered treatment-reportingmechanism rather than a clinical path-ways program. Similarly, physician medical deci-

sion-making is complex for cancerpatients, and involves multiple branch-es and considerations within a givendisease to identify the state and stage ofthe disease, as well as to think throughthe many complications of eachpatient’s health and physical stat us.This is an interactive process and notwell-suited to a static, fixed policy orpublication. Therefore, the process thatsupports the pathways program mustallow for rapid evidence-based supportof the physician’s thoughts and evalua-tions and produce an end product thatintegrates with the practice’s technicaland care delivery systems.Many of the data elements and deci-

sion points (including staging of dis-ease) are not collected in traditionalpractice and payer claims processingsystems. Thus, vendor programs thatrely on claims-based reporting, by defi-nition, cannot incorporate the scope ofdecision-making, tracking, and report-ing that is essential to a clinical path-ways program. Such programs, thus, default to

menus of approved preferred treatmentsfor a general disease, which do not pro-vide physicians or payers the degree ofcompliance, reporting, or medical deci-sion-making that is expected in a trueclinical pathways program.Require a pathways program to

incorporate front-end medical deci-sion-making, not back-end claimsreporting.Tracking and monitoring. A true clini-

cal pathways program will allow physi-cians to select treatment options thatare off-pathway where appropriate, buttrack the reasons and causes for suchvariation as part of the clinical moni-toring feedback loop. Reporting andanalysis should be available to thephysician on a patient and populationbasis that includes distribution of treat-ment by disease stage and state, byphysician, and by aggregated popula-tion; distribution of new patients bystate and stage of disease, drug utiliza-tion, and market share by class; and dis-tribution of active versus follow-uppatients. One also should expect report-ing of patient-capture rate, the on-path-way rate, clinical trial–utilization rates,and reasons for going off-pathway. Veryfew, if any, electronic health record sys-tems can produce reports at these levelsof granularity.Simplistic reporting will not yield

results; seek programs that offer adeep granularity of analysis andreporting by state and stage of disease,for all patients, not just a select few.Documented ease of physician use. A

point of clinical decision-making tool isonly as good as the number of times it isused by physicians in active clinical prac-tice. A clinical pathways program shouldbe able to document and track the ratesat which physicians use it for their entirepatient population, or for the populationof patients for whom the pathways arebeing applied. Most physicians who embrace the

selection of pathways decide to apply thepathways process to all their patients,making ease of use on one pathways plat-form across all patients essential. For thisreason, it is unlikely that a physician orphysician practice will embrace morethan one clinical pathways platform—making it more likely that payer pro-grams will adapt to accept compliancereporting from whatever platform orplatforms have been selected by thephysicians practicing in the payer’s geo-graphic market.Allow physicians to select pathways

platforms and support platforms thattrack front-end decision-making, notsimply back-end, claims-based reporting.

Dawn Holcombe, MBA,FACMPE, ACHE

A true clinical pathway is increasingly clarified as the identification ofone preferred treatmentfor a given state andstage of disease.


Clinical Pathways

Key questions to askHaving defined the distinguishing

characteristics of a true clinical pathwaysprogram, it is time to identify seven keyquestions to ask when reviewing possiblesolutions for payers or physicians:• Am I looking at a true clinical path-ways proposal?

• What is the source of the clinicalcontent, and what is the process forreview and maintenance?

• Am I satisfied with the content anddepth of compliance rates andreporting for this program?

• Does the proposed program offer doc-

umented evidence of physician satis-faction and ease of use at the point ofclinical decision-making for the clin-ical pathways program, and does thecompliance reporting track the ratesand reasons for both on- and off-path-way use, as well as accrual to clinicaltrials, at a bare minimum?

• Who is responsible for the pathwaysprogram, and what are their moti-vating factors?

• Is this program developed directlywith the physician and payers, or ifthere is a third-party vendorinvolved, what is that party’s role

and financial stake in the pro-gram—and is that fully transparentto all parties?

• Who stores and controls the data forthe program, and what do they dowith it?

ConclusionWhen done appropriately, clinical

pathways programs will decrease costsand variation in the physician’s officeand across the entire cancer spend forpayers. Understanding the distinguish-ing characteristics of pathways pro-grams and asking these seven questions

will help physicians and payers alikeseparate true clinical pathways pro-grams from programs that are labeled aspathways programs but focus more onpreferred menus of treatments—whichis a more tightly controlled way ofdefining guidelines, but which do notdeliver the same depth and detail ofcare and reporting as fully developedpathways programs. l

Part 2 of this article will focus on currentpathways programs and will appear in theOctober issue of Journal of Multi dis -ciplinary Cancer Care.

New Monoclonal Antibody Treatment Offers Hopefor Treatment of Metastatic Melanoma By Wayne Kuznar


Ahuman monoclonalantibody that blocksa receptor that down -

regulates T-cell re sponsesimproves long-term survivalin patients with previouslytreated advanced melanoma,accord ing to the results of aphase 3 trial.“This is the first time we

have shown a survival ben-efit in metastatic mela -noma,” said Steven O’Day, MD, leadinvestigator of the study, and chief ofresearch and director of the melanomaprogram at The Angeles Clinic andResearch Institute in Los Angeles.“What is equally impressive is the neardoubling in the 1-year and 2-year land-mark overall survival analyses.”The study was a head-to-head com-

parison of treatments in 676 patientswith previously treated, unresectablestage III or IV melanoma. There werethree treatment arms: mono therapy withipilimumab (n = 137), gp100 peptidevaccine alone (n = 136), and the combination of these two agents (n = 403). Ipilimumab is a fully human mono-

clonal antibody that blocks the CTLA-4 receptor (CTLA-4 is an antigenfound on T cells that downregulates theT-cell response) and potentiates T-cellactivation. gp100 is a vaccine that pro-duces T-cell–specific immune respons-es, and served as the active control armfor this study.“By blocking CTLA-4, ipilimumab

keeps the T-cell potentiated and hope-fully leads to antitumor immunity,”explained O’Day.Patients in both ipilimumab arms

achieved improvements inoverall survival. In thegp100 vaccine plus placebogroup, median overall sur-vival was 6.4 months,which is comparable withresults with placebo in pre-vious studies. In the ipili-mumab alone and the ipili-mumab plus gp100 vaccinegroups, median overall sur-vival was 10.0 months.

One-year survival was 44% inpatients who re ceived combinationtreatment with ipilimumab plus vac-cine, and 46% in those treated withipilimumab alone, compared with 25%in the gp100 vaccine group. Two-yearsurvival was 22% and 24%, respective-ly, compared with 14% in patients inthe vaccine group. Better disease control was also seen

in both groups treated with ipilimumab.After 6 months, melanoma progressionwas halted in approximately 30% ofpatients, compared with only 11% ofthose who received the gp100 vaccinealone.Serious adverse events were more

common in both ipilimumab arms, at17.4% and 22.9%, respectively, com-pared with 11.4% in the gp100 plusplacebo arm.Of significance are the side effects

with ipilimumab related to the immunesystem. These occurred in two thirds ofthe ipilimumab arm patients and inonly one third of the gp100 vaccinegroup. In ipilimumab-treated patients,T cells began attacking normal tissue atsites, the most common being dermato-logic, gastrointestinal, endocrine, andhepatic tissue.

“Ipilimumab represents a new class ofT4 potentiators and an importantadvance for the field of immunooncolo-gy,” said O’Day. “Further developmentof ipilimumab is ongoing, and we arevery excited to see that ipilimumab is

being applied to other cancers, particu-larly non–small-cell lung and prostatecancers. We are very interested in look-ing at alternative combinations with this drug, as well as in refining its dosageand schedule.” l

Steven O’Day, MDBiologic EffectiveAgainst Rare ThyroidCancerBy Caroline Helwick

An investigational multitarget-ed kinase inhibitor slowedprogression of med ullary thy-

roid carcinoma, a rare and difficult-to-treat thyroid cancer that currently hasno established treatment once it hasprogressed.

Patients treated with vandetanibhad a progression rate of 32% com-pared with 51% treated with placebo(P = .0001). At 24-month follow-up,patients receiving placebo had a medi-an progression-free survival (PFS) of19.3 months, but PFS had not beenreached for patients receiving vande-tanib, reported Samuel A. Wells, MD,

head, Thyroid Clinical ResearchProgram, the National CancerInstitute, Bethesda, Maryland.This represented a reduction in risk

of progression of 54% with vande-tanib, and in an analysis excludingplacebo recipients who crossed over toreceive this drugs the risk reductionwas 73% (P <.0001). “Statistically significant advantages

for vandetanib were also evident inthe secondary end points of objectiveresponse rate, disease control rate, bio-chemical response, and time to wors-ening pain,” Wells reported.The drug inhibits tumor angiogene-

sis and tumor-cell proliferation by tar-geting multiple receptors. Vandetanibis also being evaluated in non–small-cell lung cancer.This was the largest ever clinical

trial for medullary thyroid cancer,including 331 patients with unre-sectable locally advanced or met astat-ic disease. l

This represented areduction in risk ofprogression of 54% with vandetanib.



Financing

care provider’s financial situ-ation. Both a lease and aloan can provide ownershipoptions, so the health careprovider needs to look atwhich product serves itsneeds the best.There are two principal

lease products available. Oneproduct is a fair market valuelease. This lease is what’smost commonly associatedwith the word “lease.” The fair marketvalue lease provides lower monthly pay-ments, and the customer has the optionto return the equipment at the end of thelease term or can buy it for the equip-ment’s then fair market value. The otherlease product is referred to as a capitallease. This lease provides for the auto-matic transfer of equipment ownershipto the healthcare provider after all therequired lease payments have beenmade. This product is very similar to aloan in that equipment is owned at theend of the lease or loan term under bothtypes of financing. The customer can getthe benefits of a loan through capitalleasing, but there are still differencesamong these three products.With a fair market value lease or a

capital lease, typically 100% of the costof equipment is financed. I should alsomention that providers can lease elec-tronic health record (EHR) systems at100% of cost, depending on the bor-rower. This financing can even gobeyond the software. In some cases, aprovider can finance the installationand delivery of the equipment, as wellas training on the EHR system. A leasetypically finances a higher percentage ofwhat a healthcare provider is looking toacquire. A differentiator of leases is thatthey often include options to upgrade,purchase, or return the equipment atthe end of the term. In addition, with alease, the equipment user typically canavoid down payments, and often manu-facturers’ required progress paymentsare included. In some cases with a loanthose payments are paid by the borrow-er and subsequently financed under aloan. Another distinguishing feature ofleasing is that a fair market value lease,if structured properly, will provide thebenefits of being off balance sheet. Thiscan be very attractive, depending onthe healthcare provider’s financialstatements and how it wants to best dis-close the financing. Accounting rulesmay be changing in the future, in whichcase the off-balance-sheet benefits mayno longer be available. The timing ofwhen that change will occur is uncer-tain. But it is expected to happen. Theadditional benefit of the fair marketvalue lease is that it is a tech nologyhedge. The lease provides an easier way

to return the equipment atlease end and upgrade tonew technology.A loan, which is similar

to a capital lease, is designedto fulfill the equipmentneeds through borrowingwithout tying up a health-care pro vider’s existingready capital or lines ofcredit with the bank. Undera loan, the borrower gains

ownership of the equipment at the endof the contracted term of the financing.However, a standard bank loan oftencovers only 75% to 80% of equipmentcost, requiring a significant down pay-ment. Loans are always on balance sheet,meaning the obligation shows as indebt-edness on the healthcare provider’sbooks and the interest expense is reflect-ed in the income statement.With a properly structured fair mar-

ket value lease, only the lease payments

are in the income statement as an oper-ating expense. Future lease paymentswill generally be reflected in the finan-cial statement footnotes. A loan and afair market value lease impact the finan-cial statements very differently. A loanand a capital lease have basically thesame impact on the financial statements.

What are the tax implications of thedifferent equipment lease and loanoptions?There are various ways leasing can

leverage tax benefits to a healthcareprovider’s advantage. The financialinstitution has to balance a lot of differ-ent needs of the healthcare provider,which for tax benefits may vary depend-ing on the legal entity that is buying theequipment. For example, a nonprofit hospital can

access direct financing on a tax-exemptbasis. The tax benefits provided to thefinancial institution for lending to a

hospital are passed through to the bor-rower, which often provides theabsolute lowest cost of financing. Thislease product typically does not allowfor the option to return the equipmentat the end of the lease term. In addition,this lease typically is not allowable for aphysician group or cancer facility that isa for-profit entity.Another tax implication is that

under a loan or a capital lease, the taxbenefits of buying the equipment areretained by the borrower or the lessee.Under a properly structured fair marketvalue lease, tax benefits are retained bythe lessor, but they are effectively passedthrough to the customer through lowermonthly payments. Depending on the borrower’s tax stat -

us, it may be advantageous to do a loanor it may be beneficial to do a fair marketvalue lease. Their tax accountant canprovide some answers and can ask thefinancial institution to provide multiplelease products and compare them. Thereis not one easy answer, but there are ben-efits provided with both options.

Why lease through a financial insti-tution, such as Wells Fargo, ratherthan through the manufacturer?A bank and manufacturer typically

have very different primary objectives.These objectives may influence thefinancial products offered and how acustomer is treated during the financingterm, which can be lengthy. A manu-facturer’s finance company, referred toas a captive, is established, first andforemost, to help the manufacturermove its equipment. A bank, however,is typically interested in more than thefinancing of a particular piece of equip-ment; it is looking for a relationshipthat provides the opportunity to offeradditional bank products. Captives aregenerally more transactional in nature;banks are more interested in a long-term relationship.That is somewhat of a generalization,

but when looking at the lender’s pri-mary objectives, it is logical that a cap-tive is most interested in moving equip-ment. Trying to be somewhat objective,all captives are not created equal, andsome are relationship oriented. Becauseof their close relationship with the man-ufacturer, sometimes discounts andother support is extended to the cap-tive, which can result in attractivefinancing terms. Someone buyingequipment and looking for financingshould ask for financing from the man-ufacturer’s captive as one option to con-sider. A provider should also get a quotefrom the bank because of the potentialfor more advantageous terms.Typically, a bank has better access to

capital with a lower cost of funds com-

pared with a captive. Banks have myri-ad financial products and are, therefore,more interested in understanding theoverall business of the customer. Thebanker’s job is to find solutions for his orher customer. A captive will focus onfinancing a specific piece of equipment,and can do a very good job on financingfor that equipment. A bank, however,will offer financing of that equipment aswell as equipment from other vendors,working capital lines, real estate financ-ing, insurance products, investmentbanking services, and treasury manage-ment to name a few.

How can a practice determine howmuch it can afford?A practice must take a hard look at

its available cash flow. That will be oneof the biggest determiners of what it canafford, and what kind and how muchfinancing will be available. Additionalborrowing will impact the healthcareprovider’s financial statements—theincome statement, the balance sheet,the cash flow statement. Those state-ments are considerations in how muchcan be lent or how much a customershould look to borrow. A healthcareprovider should look at the availablecash flow after payment of the lease orloan to ensure that there will still beadequate excess cash flow to run thebusiness and provide a cushion forunexpected events. Other considera-tions are the size of the physician prac-tice or cancer treatment facility, howmany liabilities the practice already hason its books, and if it wants additionalliabilities or prefers to show less debtand more capital.

What is involved in qualifying forcredit? Is this different for large versussmall practices or new versus estab-lished practices?If a healthcare provider is financially

healthy, it can access needed capital.This would include a larger borrower, asmaller borrower, an established bor-rower, and even a startup. With a small-er borrower, less information will berequired and turnaround time should bequicker. With the financing of smallertransactions, the financial institutioncan access many online services to getan idea of a borrower’s financial condi-tion. Even for larger financial amounts,an initial assessment can be done ratherquickly by a financial institution withsignificant healthcare expertise. In or -der to obtain a formal approval, finan-cial statements will be required for thelarger financing amounts. If it’s a startupor smaller practice, personal guaranteesare typically required—this is a signifi-cant difference between a startup or

Equipment Financing...continued from cover

Peter S. Myhre

A differentiator of leasesis that they often includeoptions to upgrade,purchase, or return theequipment at the end ofthe term. In addition, witha lease, the equipmentuser typically can avoiddown payments, andoften manufacturers’required progresspayments are included.


For more information about GEMZAR, please see your Lilly sales professional or visit GEMZAR.com.

GEMZAR® is a registered trademark of Eli Lilly and Company. GC58323 0509 PRINTED IN USA © 2010, Lilly USA, LLC. ALL RIGHTS RESERVED.

Bayonne, NJ—As demand for theirservices grew and it became increasinglyclear that their practice was becoming aregional center for patients battling can-cer, the medical staff at ColantaHematology & Oncology Center madethe decision to build and open an outpa-tient infusion center that could ade-quately and comfortably serve theirpatients.The result was a state-of-the-art infu-

sion center with 20 recliners in a patient-focused environment that is open to servepatients 7 days a week. The medical staffof 3 physicians and 4 nurses, led by prac-tice administrator Romel Colanta, MD,now delivers a broad array of out patientoncology services, including chemothera-py, albumin, anti emetic, and iron therapyinfusions. Additionally, the infusion cen-ter staff provides supportive cancer careservices, including therapeutic phleboto-my, antibiotic infusion, and electrolytereplacement. They also provide multidis-ciplinary infusion services for patientsreferred to the center by gastroenterolo-gists, neurologists, and infectious diseasespecialists.With the high volume of oncology

drugs required to treat their patientpanel, the medical staff at Colanta had tomake the decision as to how they wouldsupply their patients with oncology med-ications. If they followed the traditionalpractice of hematology and oncologypro viders, they would “buy and bill” the

medications, meaning they would havethe responsibility of sourcing and pur-chasing the medications, storing them,preparing and sometimes compoundingthem for patients, managing the inventoryon an ongoing basis, and dealing with abevy of insurance prior authorization andreimbursement procedures and require-ments in order to get paid.

Although buy and bill traditionallyhad its benefits, including a substantialmargin paid by Medicare and other com-mercial payers, changes that resultedfrom the Medicare Modernization Actlowered a margin that sometimes paidphysicians 40% over the cost of the drugto just 6%.The Colanta team decided there was a

better way. They knew they could out-source the pharmacy function to a phar-macy that was highly specialized inoncology medications. This pharmacywould prepare the drugs under the high-

est clinical standards, deliver them just intime for treatment day (thereby eliminat-ing waste), handle all the hassles of insur-ance prior authorization and reimburse-ment, and free the center from thechallenges of safely storing and dispens-ing the drugs and the huge, capital-intensive “carry costs” that maintainingsuch an inventory requires.

Dr Colanta and his colleaguesresearched their options and choseOncoMed—The Oncology Pharmacy.OncoMed is an oncology pharmacy,meaning that its sole business is oncologymedications. Its specially trained and cer-tified oncology pharmacists work in atechnologically advanced pharmacy builtexclusively for oncology pharmaceuticalprescription processing and dispensing,including a USP <797>-compliant class5 clean room. To protect the supplychain and ensure a complete and fulldrug pedigree, all inventories are pur-chased directly from pharmaceuticalmanufacturers. The company’s “just-in-time treatment-day” service means thatoncologists and hematologists in anystate in the nation are guaranteed deliv-ery of medications and all therapy-specific administration supplies within24 hours of placing the order. Given theColanta Hematology & OncologyCenter’s close proximity to one ofOncoMed’s regional oncology pharmacysites, they were eligible to get same dayand even emergency stat dose deliverywhen needed.But what also set OncoMed apart from

specialty pharmacies that concentrate onmore than one class of pharmaceuticals isthe OncoMed care management supportteam’s ability to work with insurers to getthe authorizations that the ColantaHematology & Oncology Center’s pa -tients need. OncoMed’s team in cludes

patient care navigators and patient reim-bursement specialists who have extensiveexperience working with in surers,oncology drug manufacturers, and med-ical foundations. These specialistsalways know where to go to search forneeded funding for patients who arebanking on that expertise for theirrecovery.OncoMed has become a pivotal part-

ner to the Colanta Hematology & On -cology Center by owning the pharmaceu-tical worry and letting the physiciansfocus solely on guiding their patients toremission.We sat down with Dr Colanta and

asked him about the new center and itspartnership with OncoMed.

Why did your infusion center chooseto partner with OncoMed?The buy-and-bill model that oncolo-

gists have always worked under is nolonger viable. Physicians can’t make anoffice run on a 6% margin. Under buyand bill, the average sales price (ASP) +6% methodology can very quickly go toASP + 4%, +2%, or -2% if we run intoany obstacles in getting reimbursed. Andwith expensive drugs like chemotherapy,we cannot take that risk. Plus, OncoMedhelps patients get funding for medicationeven after the patient’s insurer hasdenied coverage.

In addition to this new center, younow have 2 additional sites in NewJersey. How has the partnership withOncoMed enabled you to successfullylaunch and grow the center?When we opened, 90% of what we

infused in the clinic was oncolytics. As wehave grown, we infuse a far broader arrayof medications. The backbone of our prac-tice is still chemotherapy, but we haveincreased our nononcolytic infusions. Forpatients referred by gastro intestinal practi-tioners, we in fuse infliximab, and for thosereferred by infectious disease physicians, weprovide antibiotic infusions. Some of those drugs are still viable [under buy andbill], but not all. We have been able todevote money that has traditionally goneto purchasing medication and insteadexpand our services. The partnership withOncoMed has enabled us to make betteruse of our capital.

New Jersey Hematology and Oncology Center Partners with OncoMed

Continued on next page

Evolution inOncology Practice Management

PART2OF A SERIES

OncoMed providedfunding and

editorial support for this article

www.OncoMed.net

ADVERTORIAL

(

“The partnership with OncoMed has enabledus to make better use of our capital.”

——Romel Colanta, MDPractice Administrator

Colanta Hematology & Oncology Center

The outpatient infusion center at Colanta Hematology & Oncology Center comfortably servespatients. Continued on page 15


smaller practice and a larger practice.When personal guarantees are required,the credit analysis will include retrievalfrom credit bureaus, and, depending onthe size of the transaction, personalfinancial statements and tax returnsmay be necessary.For an established cancer treatment

facility, personal guarantees may not berequired. In those cases, the lender isrelying on the demonstrated cash flowof an established business to make thelease payments and will consider thevalue of the equipment collateral in theevent of a default. With radiation treat-ment equipment, the useful life can beover 10 years, providing the lender verygood collateral. A provider can typical-ly access better terms, given the verystrong collateral value of top-tier radia-tion equipment.When financing a startup, the prac-

tice doesn’t have a track record. In ad dition, a startup typically requiresfinancing of soft costs. Therefore, therequirements for a startup versus anestablished entity are different. A start-

up that is installing a radiation treat-ment device will likely have to build avault and have significant tenantimprovements that can exceed $1 mil-lion. These can represent as much as25% to 35% of the total financing.With these projects, the financial insti-tution will likely need to look at a busi-ness plan. There will have to be enoughequity in the new business to make surethat, after preopening expenses arepaid, working capital available duringthe startup period will be adequate.Financial institutions will often look atthe referral patterns of the physiciansinvolved in the project as support forprojected revenues. A solid group ofphysicians will provide greater comfortfor the financial institution.

What should a healthcare providerconsider before selecting a financialinstitution?Just as the financial institution will

analyze the borrower and assess the proj-ect, the healthcare provider should alsolook closely at the financial institution.

Providers should look for the best finan -cing source, whether it is a bank or a cap-tive or an independent leasing company.The healthcare provider should not

think of all financial institutions asbeing the same. Do your homework.One consideration is whether the finan-cial institution has proven strength andstability so that it can take a financialhit and still be able to honor its obliga-tions to provide financing. Other con-siderations are how long the institutionhas been in business and its bond rating.A number of institutions have left thehealthcare market, are only doing busi-ness with existing customers, or simplydo not have capital to lend, making thisan important consideration.The financing source should have

experience in the healthcare industry andhave a team of veteran specialists. Thesespecialists will increase understanding ofyour business. The institution and theindividuals you choose to work withshould understand Medicare and third-party reimbursement; they should befamiliar with regulatory factors and so will

not be surprised by local healthcare mar-ket dynamics involving hospitals, physi-cians, and the payers. All these factorscan ultimately impact the approvalprocess as well as the attractiveness of theterms that are approved. Radiationoncologists, developers, joint ventures,and startups should look for financialinstitutions that are comfortable workingwith them and have experience in theirspecialty of oncology and the business ofdelivering cancer treatment. Finally, a healthcare specialist repre-

senting a financial institution should beable to present a variety of financial prod-ucts including leases and loans andfinancing that will be off balance sheet.The specialist should be able to explainthe tax benefits of each product and pro-vide a number of solutions to meet thespecific requirements of the project. Thespecialist also should be conversant aboutthe manufacturers and the models ofequipment used in cancer treatment. Inequipment financing, understanding theequipment is an important element toproviding the best financing solution. l

Equipment Financing...continued from page 12

NO. 2

To learn more about OncoMed or to request a presentation, contact OncoMed at 1-877-662-6633, extension 1298 or [email protected], or go to www.oncomed.net.

How does the medication orderingand fulfillment process work withOncoMed?

Having an efficient and focusedprocess in place is very important. Wehave been able to institute a processwhere we have someone devoted tobeing our liaison with OncoMed. Whena patient comes in and his or her benefitsare precertified, we send the person’s caseinformation to OncoMed, and the drugsare sent to us directly, along with all theadministration supplies. We get them ona next-day basis, or sooner if needed, andeverything is clearly labeled withpatient-specific information. That makesa huge difference to us when dealing withOnco Med versus some specialty pharma-cies that some insurers have imposedupon us to use, which get the drugswrong, ship them late, and have no ideaof the correct administration supplies.

How does the relationship withOncoMed allow you and your team to

focus on what is important?I will give you a “before-and-after”

example. Before we worked with Onco -Med, 50% or more of our time was spenton managing drug costs and reimburse-ment. We had 5 people managing pharmacy at the 3 locations; we havebeen able to reduce that number ofemployees to 1. Before, we had to con-tinually make sure that we were notunderwater on drugs, as reimbursementrates and times fluctuated. OncoMedhas made it possible to not devote timeand effort on that.

Based on your experience, whatwould you say about OncoMed to he -matologists and oncologists consideringsuch a move?

It is definitely a relationship that everyinfusion center or oncologist has toexplore. When dealing with narrowingreimbursement margins and delayedreimbursement, ultimately it will be ben-eficial to switch to OncoMed. �

Continued from page 22

EVOLUTION IN ONCOLOGY PRACTICE MANAGEMENT™

THE LEADERSHIP OF ONCOMED – THE ONCOLOGY PHARMACY

Pharmacists filling orders at the OncoMed facility.

Ellen Scharaga, RPhSenior Vice PresidentOncoMed

Kevin Askari, RPhPresident and Chief Clinical PharmacistOncoMed

Burt ZweigenhaftCEO, OncoMed

p



CONTINUING EDUCATION

PROGRAM CME001 • RELEASE DATE: AUGUST 15, 2010 • EXPIRATION DATE: AUGUST 14, 2011

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Science Care designates this educational activity for a maximum of 1.0 AMA PRA Category 1Credit(s)™. Physicians should only claim credit commensurate with the extent of their participationin the activity.

METHOD OF PARTICIPATION1. Read the article in its entirety2. Go to www.JOMCC.com3. Select "Continuing Education"4. Click on this article's title from the list shown5. Select "Click here to complete the posttest and obtain a CME certificate online"6. Complete and submit the CME posttest and CME Activity Evaluation7. Print you Certificate of Completion

This activity is provided free of charge to participants.

FINANCIAL DISCLOSURESAs a provider accredited by the ACCME, Science Care must ensure balance, independence, objec-tivity, and scientific rigor in all its activities. All course directors, faculty, planners, and any otherindividual in a position to control the content of this educational activity are required to disclose tothe audience any relevant financial relationships with any commercial interest. Science Care mustdetermine if the faculty's relationships may influence the educational content with regard to expo-sition or conclusion and resolve any conflicts of interest prior to the commencement of the educa-tional activity. Disclosures are as follows:• Jose Correa, MD, has nothing to disclose. • Karen Rosenberg has nothing to disclose.• Surendra Kolla, MD, has nothing to disclose. • Wade J. Sexton, MD, has nothing to disclose. • Dawn Lagrosa has nothing to disclose. • Philippe E. Spiess, MD, MS, has nothing to disclose.

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DISCLAIMERThe opinions and recommendations expressed by faculty, authors, and other experts whose inputis included in this program are their own and do not necessarily represent the viewpoint of ScienceCare or Green Hill Healthcare Communications, LLC.

Copyright © 2010 Science Care. All rights reserved.

STATEMENT OF NEEDMajor improvements have been made in the prognosis of patients with testicular cancer over thepast 20 years with overall disease-specific survival rates exceeding 90%, because of the carefulintegration of improved systemic platinum-based chemotherapy regimens and surgical techniques.This multimodality treatment paradigm consisting of systemic chemotherapy followed bypostchemotherapy retroperitoneal lymph node dissection is critical to the management of patientswith metastatic nonseminomatous germ-cell tumors (NSGCTs). This requires a commitment by eachmember of the multidisciplinary team to communicate effectively and acknowledge the individualcontributions each can make toward the care and toward the cure of testis cancer patients. This arti-cle will help team members recognize thought processes behind the other members’ treatmentdecisions.

TARGET AUDIENCEMedical, surgical, and radiation oncologists, and other interested healthcare professionals, espe-cially those caring for cancer patients.

LEARNING OBJECTIVESAfter completing this activity, the reader should be able to:• Recognize the histologic, staging, and prognostic classifications of metastatic nonseminomatousgerm-cell tumors (NSGCTs)

• Develop management strategies for patients with metastatic NSGCTs based on histologic, stag-ing, and prognostic classifications

• Institute a surveillance protocol for patients with NSGCTs following postchemotherapy retroperi-toneal lymph node dissection

Multidisciplinary Approach to MetastaticNonseminomatous Germ-cell Testis TumorsPhilippe E. Spiess, MD, MS; Jose Correa, MD; Surendra Kolla, MD; Wade J. Sexton, MDGenitourinary Oncology Program, H. Lee Moffitt Cancer Center, Tampa, Florida

In 2009, testicular cancer is estimatedto affect 8400 men and result in 380deaths in the United States.1 It is the

most common malignancy in men aged20 to 40 years. Hence, by its verynature, testis cancer is a life-alteringevent in a young subset of patients.Major improvements have been madein the prognosis of patients with testic-ular cancer over the past 20 years withoverall disease-specific survival (DSS)rates ex ceeding 90%, because of thecareful integration of improved systemicplatinum-based chemotherapy regimensand surgical techniques.2 Today, thismultimodality treatment paradigm consisting of systemic chemotherapyfollowed by postchemotherapy retro -peritoneal lymph node dissection (PC-RPLND) is critical to the managementof patients with metastatic nonsemino-matous germ-cell tumors (NSGCTs).

Histology, staging, and prognosticclassification of metastatic NSGCTsTesticular cancer can be subdivided

into seminomatous tumors (30%-60%)

and NSGCTs (40%-70%). NSGCTsare further categorized into embryonal,yolk sac, choriocarcinoma, and ter-atoma (mature and immature) histolo-gies, although most NSGCTs comprisea mixture of the aforementioned his-tologies to include seminomatous ele-ments. Serum tumor markers consistingof serum α-fetoprotein (AFP), β-humanchorionic gon ad otropin (HCG), andlactic dehydrogenase (LDH) are used inthe diagnosis, treatment, and surveil-lance of testicular cancer.The 1997 American Joint Com -

mittee on Cancer Staging System is themost frequently used staging system fortesticular cancer:• Stage I—confined to the testis• Stage II—confined to retroperitoneallymph nodes• Stage IIA—largest retroperitoneallymph node ≤2 cm

• Stage IIB—retroperitoneal lymphnodes between 2 cm and 5 cm

• Stage IIC—largest retroperitoneallymph node >5 cm

• Stage III—involve metastatic sites

other than retroperitoneal lymphnodes.Patients with NSGCTs

can be categorized intothree prognostic groupsaccording to the 1997International Germ CellConsensus Classification(IGCCC) guidelines3:• Good—testis/retroperi-toneal primary, no non-pulmonary visceral met -astases, and favorabletumor markers (AFP<1000 ng/mL, HCG <5000 IU/L,and LDH <1.5 x upper limit of nor-mal)

• Intermediate—testis/retroperitonealprimary, no nonpulmonary visceralmetastases, and intermediate-risktumor markers (AFP 1000 ng/mL to10,000 ng/mL, HCG 5000 IU/L to50,000 IU/L, and LDH 1.5 x to 10 xupper limit of normal)

• Poor—mediastinal primary germ-celltumor, or nonpulmonary visceralmetastases, or high-risk tumor mark-

ers (AFP >10,000 ng/mL, HCG>50,000 IU/L, and LDH >10 x

upper limit of normal).

Systemic chemotherapyfor metastatic NSGCTsHistorically, actinomycin

D was one of the first sys-temic agents used in themanagement of NSGCTs,demonstrating responserates of about 50% andcomplete response ratesbetween 15% and 20%.4

Subsequently, single-agent vinblastineand bleomycin were proposed andachieved similar response rates to theactinomycin D regimen.5 Thereafter, itwas noted that metastatic NSGCTsexhibited significantly better responserates to multiagent platinum-basedchemotherapy, and the traditionalbleomycin, etoposide, and cisplatin(BEP) regimen was adopted as a first-line approach for metastatic disease.6One of the major concerns with theBEP regimen, however, is bleomycin-

Philippe E. Spiess, MD, MS


www.JOMCC.com

induced pulmonary toxicity. Therefore,the doublet regimen of etoposide andcisplatin (EP) has been proposed.Although still highly debatable, someoncologists believe that for good-riskIGCCC patients, four cycles of EP mayhave efficacy similar to three cycles ofBEP. Others argue that three cycles ofBEP has improved treatment-specificoutcomes, albeit at the expense ofpotentially higher pulmonary toxicity.7,8Cur rently, both regimens are consider -ed acceptable for good-risk patientsaccording to the NationalCompre hensive CancerNetwork guidelines and arethe most frequently usedfirst-line systemic therapyregimens for metastaticNSGCTs.9 For patientsexhibiting marker elevationor disease progression afterfirst-line chemo therapy,additional systemic chemo -therapy is often recom-mended, typically consisting of vinblas-tine, ifosfamide, and cisplatin (VIP), asthis regimen has been shown to be anefficacious second-line salvage therapywith acceptable toxicity.10 For patients

with disease progression after second-line VIP-based chemo therapy, high-dosechemotherapy and autologous bone-marrow transplantation are typicallyrecommended.11

Indications for PC-RPLNDThere are clear indications for PC-

RPLND in patients with NSGCTs. Themost common indication is the presenceof a radiographic residual mass in thepatient who has received systemic chemo - therapy for me tastatic disease and who has

normal tumor markers. Path -ologic findings in the resect -ed surgical specimen from pa tients undergoing PC-RPLND following inductionchemotherapy (typically BEPx 3 or EP x 4 for good-riskpatients, BEP x 4 for interme-diate- and poor-risk patients)include fibrosis in 40%, ter-atoma in 40%, and viablegerm-cell tumor in 20%.12 As

such, 60% of patients will derive a benefitfrom surgery by the resection of viablecancer or teratoma. The risk of havingviable cancer in the surgical specimenincreases to 50% or more in patients

undergoing PC-RPLND following salvagechemotherapy.13Another indication for PC-RPLND

is in the patient with tumor growth dur-ing or after systemic chemotherapy,despite normalization of serum tumormarkers. This condition is characteris-tic of growing teratoma syndrome(GTS).14 In a recent surgical series, theexcellent outcomes of patients withGTS managed by PC-RPLND wereconfirmed.15 It is important to followthe serum tumor markers and the radio-logic response of metastatic germ-celltumors to chemotherapy, because GTSis chemo refractory andshould be managed by PC-RPLND within severalweeks of the diagnosis. Adelay in surgery couldincrease the complexityand the morbidity of thesurgical resection.Finally, a “desperation

PC-RPLND” is indicated insome patients with meta -static NSGCTs who despitetreatment with maximal courses ofchemo therapy, have persistently elevat-ed serum tumor markers, indicating the

presence of viable germ-cell elementsother than teratoma. The “desperationPC-RPLND” is an attempt to surgicallyresect all sites of disease. Although his-torically associated with a poor progno-sis, more recent experience details opti-mistic outcomes in 48 patients under going“desperation PC-RPLND,” with 79% ofpatients exhibiting no evidence of dis-ease at a median follow-up of 46months.16A controversial indication for a PC-

RPLND involves patients with metasta-tic NSGCTs with complete radiograph-ic resolution of metastatic sites and

normalization of serumtumor markers. The risk ofrelapse in this subset ofpatients is approximately5% without PC-RPLND,which most surgical oncolo-gists would accept as suffi-ciently low to negate thenecessity of PC-RPLND inthis patient cohort.17 Arecent study corroboratesthe favorable natural history

of metastatic tumors in patients whoattain a complete response (radiograph-ic and serologic) and who undergo sur-

Table. Recommended Surveillance Protocol in Testicular Cancer Patients Following PC-RPLND

3 6 9 12 15 18 21 24 27 30 33 36 Yearly for 5 years

Clinical stage IIAHistory x x xPhysical examinationa x x xSerum tumor markersb x x xChest x-ray x x xAbdominal/pelvic CT imaging x x x

Clinical stage IIBHistory x x x x x x xPhysical examinationa x x x x x x xSerum tumor markersb x x x x x x xChest x-ray x x x x x x xAbdominal/pelvic CT imaging x x x x x x x

Clinical stage IICHistory x x x x x x xPhysical examinationa x x x x x x xSerum tumor markersb x x x x x x xChest x-ray x x x x x x xAbdominal/pelvic CT imaging x x x x x x x

Clinical stage IIIHistory x x x x x x x x x x x x xPhysical examinationa x x x x x x x x x x x x xSerum tumor markersb x x x x x x x x x x x x xChest x-ray x x x x x x x x x x x x xAbdominal/pelvic CT imaging x x x x x x x

aPhysical examination includes a head and neck examination and brief neurologic evaluation.bSerum tumor markers include �α-fetoprotein (AFP), �β-human chorionic gonadotropin (HCG), and lactic dehydrogenase (LDH).

CT indicates computed tomography; PC-RPLND, postchemotherapy retroperitoneal lymph node dissection.

Reprinted with permission from Spiess PE, Brown GA, Liu P, et al. Recurrence patterns and proposed surveillance in patients following post-chemotherapy retroperitoneal lymph node dissection. J Urol.2007;177:131-138. Copyright © 2007. Elsevier/American Urological Association.

Jose Correa, MD

Surendra Kolla, MD


CONTINUING EDUCATION

veillance only following chemothera-py.18 Nevertheless, some centers stillpromote PC-RPLND in this clinicalcontext.19

Treatment-related outcomesPC-RPLND is an essential diagnostic

and therapeutic intervention in patientswith metastatic NSGCT. Technicalrefinements and a better understandingof retroperitoneal anatomy and physi-ology have resulted in significantimprovements in the disease-specificoutcomes as well as minimizing treat-ment-related morbidity. The prognosisof patients undergoing PC-RPLND ismost strongly correlated with thepathologic findings at the time of sur-gery. Patients with fibrosis and/or ter-atoma have a 10% to 18% risk ofrelapse, whereas patients with viablegerm-cell tumor elements have up to a70% risk of relapse despite the adminis-tration of two additional cycles of adju-vant chemotherapy.20Factors predictive of DSS have been

determined from retrospective reviewsand multivariate analyses of patientsundergoing PC-RPLND. These factorsinclude systemic symptoms at presenta-tion, elevated pre-RPLND serum AFP(>9 ng/mL) or HCG (>4100 IU/L),postoperative complications, and can-cer recurrence after PC-RPLND.19Recurrence-free survival (RFS) isimpacted by advanced clinical stage(IIC-III) and the presence of viabletumor in the PC-RPLND specimen.21Furthermore, the clinical outcomes ofpatients harboring viable germ-celltumor elements at the timeof PC-RPLND were evalu-ated, and an attempt wasmade to determine whetherthe presence of viable tumorin the surgical specimencould be predicted.22 Theincidence of viable tumor atthe time of PC-RPLND inthe good, intermediate, andpoor IGCCC categorieswere similar (17.8%, 15.6%,and 15.3%, respectively); however, theIGCCC prognostic categories predictedDSS and RFS consistent with the earli-er findings of the International GermCell Cancer Collaborative Group.3 Onmultivariate analysis, an elevated serumAFP level before PC-RPLND and thesize of the retroperitoneal mass onpathology review were both predictiveof viable tumor in the surgical speci-men. Unfortunately, aside from thepatients who achieve a completeresponse to chemotherapy, none of theaforementioned predictors (alone or incombination) can be used with suffi-cient accuracy to avoid surgery in anyother subset of patients. Progression-free survival (PFS) after

PC-RPLND can be predicted based on acombination of various clinical and

pathologic features. Fizazi and col-leagues reviewed the outcomes of 238patients with viable residual NSGCTsfollowing first-line chemotherapy.23 Theoverall 5-year PFS was 64% and, onmultivariate analysis, the significantpredictors included incomplete surgicalresection, viable malignant cells >10%,and poor or intermediate IGCCC cate-gories. Patients not having any of theseadverse features had a 5-year PFS of90%, compared with 41% in patientswith two or more adverse features.23 Onthe contrary, Spiess and colleagues eval-uated the treatment-related outcomesof patients with no viable tumor in thePC-RPLND specimen.24 Of 195 pa -tients with fibrosis and/or teratoma atthe time of PC-RPLND, 18% (35) of pa -tients developed subsequent recurrencesand 9% (18) died of disease at a medianfollow-up of 45 months. On multivari-ate analysis, the only predictors of RFSin these patients was advanced clinicalstage (IIC-III), and the predictors ofDSS included an elevated serum HCGbefore PC-RPLND, pathologic diame-ter of the retroperitoneal mass (>2.5cm), and postoperative tumor recur-rence. Therefore, although patientswith fibrosis or teratoma only in thePC-RPLND specimen have a lower riskof disease recurrence compared withpatients with viable germ-cell elements,both subsets of patients require carefulpostoperative surveillance to detect andtreat disease recurrences.25As previously described, a subset of

patients have elevated serum tumormarkers despite receiving the maximal

amount of preoperativechemotherapy and may beoffered a “desperation PC-RPLND” in an attempt toremove all sites of visibledisease. Beck and colleaguesupdated their single-centerexperience with the “des-peration PC-RPLND” groupof patients and found viablegerm-cell tumor elements in more than 50% of pa -

tients.26 After a median follow-up of 6years, 54% of patients remained alive.On multivariate analysis, several predic-tors of poorer DSS were identified,including the rate of change of HCGbefore surgery, an elevated preoperativeAFP, a prior attempt at a PC-RPLND,and the presence of viable germ-celltumor at the time of surgery. Clearly, patients undergoing a PC-

RPLND, a “desperation PC-RPLND,”or a repeat PC-RPLND constitute ahigh-risk population in terms of diseaseprogression and surgical morbidity.26,27Nevertheless, an aggressive and com-plete resection may offer a chance atlong-term survival and cure in patientsrequiring surgical consolidation follow-ing chemotherapy, and in patientsexhibiting chemorefractory behavior.

Understandably, this operation shouldbe performed at tertiary care referralcenters with extensive experience inthe surgical management of complextestis cancer cases.

Postoperative follow-upFollowing PC-RPLND, patients re -

main at risk of disease recurrence pre-dominantly within the chest (49%),abdomen (22%), and supraclavicularlymph nodes (13%).25 The risk of aninfield recurrence remains acceptablylow (1%) when surgery is performed atcenters of excellence by experienced sur-geons. In a recent retrospective review ofpatients undergoing PC-RPLND at TheM. D. Anderson Cancer Center, the riskof disease recurrence was strongly associ-ated with the patient’s clinical stage.Based on the patterns of recurrence fol-lowing PC-RPLND for metastaticNSGCTs, a stage-specific surveillanceguideline was proposed (Table).25 Thesurveillance strategy was based entirelyon the patterns of recurrence over a 25-year period, during which systemicchemotherapeutic regimens evolved dra-matically. However, using a combinationof history, physical examination, serumtumor markers, and radiologic imaging(chest film, abdominal/pelvic CT imag-ing), the surveillance strategy provides aframework that can be adopted by clini-cians to help identify recurrences at theirmost likely time and site of occurrence.

ConclusionsPatients with metastatic testicular

cancer have a high probability of curewith multimodality therapy, consistingof systemic chemotherapy and PC-RPLND. Careful detail to patient- anddisease-related parameters may opti -mize the cancer-specific outcomes while minimizing morbidity. MetastaticNSGCTs serve as a model on how theoptimal integration of effective systemicchemotherapy and surgical consolida-tion (ie, PC-RPLND) can render excel-lent oncologic outcomes. This requiresa commitment by each member of themultidisciplinary team to communicateeffectively and acknowledge the indi-vidual contributions each can maketoward the care and toward the cure oftestis cancer patients. Future basic sci-ence and clinical studies will help betterdefine ways of optimizing the outcomesin this young patient population. l

References1. Jemal A, Siegel R, Ward E, et al. Cancer statistics,2009. CA Cancer J Clin. 2009;59:225-249.

2. Mannuel HD, Hussain A. Update on testicular germcell tumors. Curr Opin Oncol. 2009;21:254-259.

3. International Germ Cell Cancer CollaborativeGroup. International Germ Cell Consensus Class -ification: a prognostic factor-based staging systemfor metastatic germ cell cancers. J Clin Oncol.1997;15:594-603.

4. Srinivas S, Freiha FS. Actinomycin D revisited in tes-ticular cancer: a case report. Tumori. 1999;85:78-79.

5. Bosl GJ, Geller NL, Bajorin D, et al. A randomizedtrial of etoposide + cisplatin versus vinblastine +bleomycin + cisplatin + cyclophosphamide +dactinomycin in patients with good-prognosis germ

cell tumors. J Clin Oncol. 1988;6:1231-1238.6. Horwich A, Sleijfer DT, Fossa SD, et al. Ran -domized trial of bleomycin, etoposide, cisplatincompared with bleomycin, etoposide, and carbo-platin in good-prognosis metastatic nonseminoma-tous germ cell cancer: a Multiinstitutional MedicalResearch Council/European Organization forResearch and Treatment of Cancer Trial. J ClinOncol. 1997;15:1844-1852.

7. Culine S, Theodore C, Terrier-Lacombe MJ, DrozJP. Are 3 cycles of bleomycin, etoposide, and cis-platin or 4 cycles of etoposide and cisplatin equiva-lent optimal regimens for patients with good riskmetastatic germ cell tumors of the testis? The needfor a randomized trial. J Urol. 1997;157:855-858.

8. Culine S, Kramer A, Theodore C, et al. Ran -domized trial comparing bleomycin/etoposide/cis-platin with alternating cisplatin/cyclophosphamide/doxorubicin and vinblastine/bleomycin regimens ofchemotherapy for patients with intermediate- andpoor-risk metastatic nonseminomatous germ celltumors: Genito-Urinary Group of the FrenchFederation of Cancer Centers Trial T93MP. J ClinOncol. 2008;26:421-427.

9. National Comprehensive Cancer Network. ClinicalPractice Guidelines in Oncology: Testicular Cancer.V.1.2008. www.nccn.org/professionals/physician_gls/PDF/testicular.pdf. Accessed August 24, 2009.

10. Farhat F, Culine S, Theodore C, et al. Cisplatin andifosfamide with either vinblastine or etoposide assalvage therapy for refractory or relapsing germ celltumor patients: the Institut Gustave Roussy experi-ence. Cancer. 1996;77:1193-1197.

11. Broun ER, Nichols CR, Turns M, et al. Early salvagetherapy for germ cell cancer using high-dosechemotherapy with autologous bone marrow sup-port. Cancer. 1994;73:1716-1720.

12. Einhorn LH. Testicular cancer as a model for a cur-able neoplasm: the Richard and Hinda RosenthalFoundation Award Lecture. Cancer Res. 1991;41(9pt 1):3275-3280.

13. Donohue JP, Leviovitch I, Foster RS, et al.Integration of surgery and systemic therapy: resultsand principles of integration. Semin Urol Oncol.1989;16:65-71.

14. Logothetis CJ, Samuels ML, Trindade A, JohnsonDE. The growing teratoma syndrome. Cancer.1982;50:1629-1635.

15. Spiess PE, Kassouf W, Brown GA, et al. Growingteratoma syndrome: The M. D. Anderson CancerCenter experience. J Urol. 2007;177:1330-1334.

16. Murphy BR, Breeden ES, Donohue JP, et al.Surgical salvage of chemorefractory germ celltumors. J Clin Oncol. 1993;11:324-329.

17. Beck SDW, Foster RS. Long-term outcome of retro -peritoneal lymph node dissection in the managementof testis cancer. World J Urol. 2006;24:267-272.

18. Kakiashvili D, Anson-Cartwright L, Moore M, et al.Post-chemotherapy retroperitoneal lymph node dis-section for testicular germ cell tumors: Is surgeryindicated in all and is bilateral template necessary?Princess Margaret Hospital experience. J Urol.2009;181:325. Abstract 911.

19. Sheinfeld J. The role of adjunctive postchemother-apy surgery for nonseminomatous germ-cell tumors:current concepts and controversies. Semin UrolOncol. 2002;20:262-271.

20. Stephenson AJ, Sheinfeld J. The role of retroperi-toneal lymph node dissection in the management oftesticular cancer. Urol Oncol. 2004;22:225-235.

21. Spiess PE, Brown G, Liu P, et al. Predictors of out-come in patients undergoing postchemotherapyretroperitoneal lymph node dissection for testicularcancer. Cancer. 2006;107:1483-1490.

22. Spiess PE, Brown G, Pisters LL, et al. Viable malig-nant germ cell tumor in the postchemotherapyretroperitoneal lymph node dissection specimen:can it be predicted using clinical parameters?Cancer. 2006;107:1503-1510.

23. Fizazi K, Tjulandin S, Salvioni R, et al. Viablemalignant cells after primary chemotherapy for dis-seminated nonseminomatous germ cell tumors:prognostic factors and role of postsurgery che -motherapy—results from an international studygroup. J Clin Oncol. 2001;19:2647-2657.

24. Spiess PE, Tannir NM, Brown GA, et al.Recurrence in nonseminomatous germ cell testistumor patients with no viable tumor at time ofpostchemotherapy retroperitoneal lymph node dis-section. Urology. 2007;70:1173-1178.

25. Spiess PE, Brown GA, Liu P, et al. Recurrence pat-terns and proposed surveillance in patients follow-ing post-chemotherapy retroperitoneal lymph nodedissection. J Urol. 2007;177:131-138.

26. Beck SD, Foster RS, BihrleR, et al. Pathologic find-ings and therapeutic outcome of desperation post-chemotherapy retroperitoneal lymph node dissec-tion in advanced germ cell cancer. Urol Oncol.2005;23:423-430.

27. Sexton WJ, Wood CG, Kim R, Pisters LL. Repeatretroperitoneal lymph node dissection for metastat-ic testis cancer. J Urol. 2003;169:1353-1356.

Wade J. Sexton, MD

A Newsletter Series for Cancer Care Professionals

Center of Excellence Media, along with Editor-in-ChiefSagar Lonial, MD, of Emory University, are pleased tooffer your multidisciplinary cancer team this series ofnewsletters focusing on the challenges of treatingpatients with multiple myeloma.

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CASE STUDY DISCUSSIONS:

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Target AudienceThese activities were developed for physicians, nurses, and pharmacists.

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Psychosocial Issues

A Team Approach to Psychosocial CareBy Susan S. Hendrick, PhDHorn Professor of Psychology, Texas Tech University, Lubbock

Everardo Cobos, MDProfessor and Associate Dean for Oncology Programs; Division Chief, Oncology/Hematology, Texas Tech University, School of Medicine, Lubbock

Vasia Craddick, RNC, BSNDirector of Clinical Operations, Southwest Cancer Treatment and Research Center, Lubbock, Texas

The ripple effectThis case example presents state-of-

the-art treatment for cancer, and it cantake place in virtually every cancer cen-ter and oncology practice in the commu-nity. Cancer’s ripple effect is apparent toall who work in oncology. The tradition-al medical focus has been on thepatient’s disease, sometimes on thepatient and the disease, and in recentyears also on those closest to the patientwho are most hit by the ripple effect.Many eminent organizations have takennote of this ripple effect and its psy-chosocial cost for the patient and closeothers. The Institute of Medicine ad -dressed psychosocial issues in its volumeCancer Care for the Whole Patient:Meeting Psychosocial Needs,1 and otherpublications such as those from theAmerican Cancer Society address can-cer’s emotional toll. This article de- s cribes a practical, counseling teamapproach to psychosocial care that workseffectively within the larger multidisci-plinary team approach common in manyof today’s cancer treatment settings.

The cancer centerThe Southwest Cancer Treatment

and Research Center (SCTRC) is aregional cancer center affiliated withTexas Tech University School ofMedicine and administered jointly byTexas Tech University Health SciencesCenter and University Medical Center(UMC), a teaching hospital that is alsothe county hospital. SCTRC had morethan 24,000 patient visits in 2009. It isaccredited by the American College ofSurgeons Commission on Cancer and is a member of the Southwest Oncol -ogy Group, the Children’s Oncol ogy

Group, and the Cancer Trials SupportUnit. SCTRC is involved in numerousclinical trials. It also administers aninpatient bone marrow transplant(BMT) unit and serves a large catch-ment area in west Texas and easternNew Mexico.Although it began in 1991 and

opened a greatly expanded and updatedfacility in 2004, the SCTRC did notoffer a consistent program of psychoso-cial services until summer 2004, when itbegan a novel partnering with TexasTech University’s Department of Psy -chology. Aided initially by a federalgrant, a practicum site for clinical andcounseling psychology doctoral studentswas set up at SCTRC. Beginning withone student and currently sustaining 8students, SCTRC has nurtured itscounseling team even as it has addedother psychosocial providers, such as itspatient navigator who is funded, in part,by the American Cancer Society.

What the team doesThe current team of 10 includes three

students with positions funded by UMCfor 10 hr/week, and seven studentsworking either 0.5 day/week (a halfpracticum) or two 0.5 day/week (a fullpracticum). SCTRC is typically staffedfor all of the working week (Monday-Friday), except Friday afternoons. Anadditional team member, the supervisorwho is a Texas Tech University psychol-ogy professor, works 0.5 day/week as thecounselor at the dedicated clinic for

lung cancer patients. This clinic is alsostaffed by a medical oncologist, pulmo-nologist, lung surgeon, and nurse practi-tioner. Students typically self-select intoa particular site within SCTRC, thoughthe team members carry pagers and at -tempt to provide coverage wherever it isneeded. Some counselors work along-side physicians and extenders in theoutpatient clinics, whereas others preferthe infusion area or the BMT unit,where they can spend more time talkingwith patients and family members. Allcounselors try to help staff the radiationarea. A patient, such as the one in thecase example, might encounter severalcounselors in the course of his or hertreatment, for example, touching basebriefly in the clinic, talking at greaterlength (and depth) in the infusion suite,and sometimes seeing a counselor in theradiation area.Continuity of care is always an issue.

Weekly group supervision of the teamand extensive note taking and ex -change allow the team to functionmuch like a relay team rather than as aseries of unconnected individuals. Theteam has seen many members come andgo during the 6 years of its existence(nearly 30 counselors, including currentones). The unifying themes across stu-dents and years have been (1) commit-ment to patient service, (2) particularinterest in working with ill people in anoutpatient medical setting, and (3)unfailing team cohesiveness. No onehas been recruited to the team; virtual-ly every counselor has sought out theteam.Much of the therapeutic work is sup-

portive counseling and assessment ofanxiety and depression in patients and,just as commonly, in their spouse/part-ner. During a recent afternoon, onecounselor celebrated with a patient whowas diagnosed with a benign breastlump instead of breast cancer, helped anadult woman come to terms with her

Karen is a 35-year-old married mother of two(Anna, age 11 and Kevin, age 9), who is a high schoolhistory teacher. She visited her primary care physi-cian after she found a lump in her breast. Subsequenttesting confirmed there was a small mass. She wasdiagnosed with stage II, non–estrogen-dependentcancer in her left breast. Treatment involved lumpec-

tomy, radiation, and chemotherapy—as well aspatient education, navigation through the healthcaresystem, and individual, couple, and family counsel-ing. The individual counseling focused on anxiety,depression, and the pressure to think positive. Thecouple counseling focused on patient and caregiverstresses, caregiver burden, and communication

between the spouses. Family counseling focused onoffering age-appropriate information about bothbreast cancer and their mother’s condition for thechildren, describing the family as a team, and provid-ing a picture of the family’s new normal. Karen is nowin remission, yet the cancer center counselors con-tinue to check in with her at every visit.

Case Report

Left to right, front row: Kristin Goodheart, Abby Diehl, Erin Logue, AndrewFriedman; back row: Susan Hendrick, Ryan Graham, Matt Ashton, RBWatts, Cynthia Willmon.

Cancer patients and their families have a need to be understood on their verydifficult journey and to be appreciated for their struggle. The physician has timepressures, fears not doing enough or doing too much, and has a wish to reallyconnect with each patient and family. Yet no one person can meet all the needsof the patient and his or her family, making the team approach essential. Thecounselors are observers, translators, and sometimes almost serve as a physi-cian’s sixth sense. The counselors are a natural part of the treatment team. Idon’t know how we used to get along without them.

—Everardo Cobos, MD, Chief Medical OncologistContinued on page 26

www.ValueBasedCancer.com

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� ��

��

A new publication for your new vocabulary

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NCCN Roundtable: Clinical andEconomic Issues Impacting Cancer Care Delivery “Collision course” in sight

©2010 Engage Healthcare Communications, LLCContinued on page 24

Baltimore, MD—A long-held businesstruism is that “if you can’t measure it,you can’t manage it.” The application of this belief to the oncology setting was demonstrated at a session of theAssociation of Community Cancer Cen ters’ (ACCC) 36th Annual NationalMeeting. Kimberly Bergstrom, PharmD,chief clinical officer for McKessonSpecialty Care Solutions, told attendeesof the growing importance of developingand using standardized chemotherapytreatment regimens, and of the tools that

can benchmark performance and fostercompliance with treatment guidelines.Public and private payers are mov-

ing to control exploding healthcarecosts, Dr Bergstrom told attendees,and because increased cost controlwas inevitable, it is in providers’interest to get a seat at the table. “It is an important topic, because

this is one of those things, if we don’tget a handle on it, it’s going to happento us,” she said. “People and groupsand organizations are going to startdictating how we provide cancer care,and we can’t let that happen.”

Hollywood, FL—Clinical practiceguidelines issued by the NationalComprehensive Cancer Network(NCCN) are followed by conscien-tious oncologists in their everydaypractice, but they are developedbased on clinical efficacy and withoutregard to costs. At a roundtable heldduring the NCCN’s 15th AnnualConference, moderator CliffordGoodman, PhD, Senior Vice Presidentat The Lewin Group, predicted, “Theappropriate use of evidence-basedguidelines is on a collision coursewith the financial nonsustainability ofthe healthcare system.”

Dr Goodmanalluded to a levelof frustration thathas never beenhigher in cancercare. “Too manypatients are stilldying young. Weneed innovations and a cure,” he said.But the inadequacy of current treat-ments for cancer is no longer the mainproblem. Equally challenging, he sug-gested, is finding a means to pay forthe ever-costlier care that threatens tobankrupt the healthcare system. As society struggles to find solu-

tions, “the ground is shaking beneathus,” Dr Goodman commented.

Continued on page 8



By Audrey Andrews

SEER-Medicare Database AnalysisConfirms Expensive ProstateCancers Gaining SupremacyBut cost-effectiveness of this move remains to be determined

San Francisco, CA—The popularity ofminimally invasive radical prostatec-tomy (MIRP), intensity-modulatedradiation therapy (IMRT), and ofbrachytherapy combined with IMRTfor prostate cancer started to take offafter 2002, a new database analysishas confirmed.At the American Society of Clinical

Oncology’s 2010 Genitourinary Can -cers Symposium, Paul L. Nguyen,MD, presented the results of histeam’s analysis of data from theSurveillance, Epidemiology and EndResults (SEER)-Medicare database.Dr Nguyen, director of Prostate

Brachytherapy, Dana-Farber/Brigham

and Women’s Hospital, HarvardMedical School, Boston, and his co-investigators found MIRP jumpedfrom 1.5% of radical prostatectomies(RPs) in 2002 to 28.7% in 2005. Theyalso found that IMRT soared from8.7% of external radiation treatmentsfor prostate cancer to 81.7%. In addi-

By Rosemary Frei, MSc

New Tools Arriving to Measure andManage Chemotherapy CareBusiness, clinical concerns now connected in value-focused approach By Daniel Denvir

Breast Cancer Survival Improves,Thanks to New Therapies

The 2010 Genitourinary CancersSymposium: Progress in Multi -disciplinary Management was heldMarch 5-7 in San Francisco. All ses-sions emphasized a multidisciplinaryap proach to care; a number of thembrought out the cost and value issuesassociated with caring for genitouri-nary cancers.

Value-Based Cancer Carewill be at the ASCO Annual Meeting, June 4-8, in Chicago. Please visit us at booth 18121

Barcelona—Survival for patients withmetastatic breast cancer has improveddramatically in the last 20 years, espe-cially in the subgroup of patients withHER2-positive tumors, according toresearch presented at the 7th European

Breast Cancer Confer ence (EBCC7).This improvement, the researcherssuggest, is due to in creased use ofanthracyclines and the rise of targetedtherapies.“There is no doubt that trastuzu -

mab (Herceptin), which targets theHER2 gene, is the most important

By Colin Gittens


��

Photo by © ASCO/Todd Buchanan 2009

value-focused

payers

cost control

clinical practiceguidelines

cost effectiveness

efficacy

NCCN Roundtable: Clinical andEconomic Issues Impacting Cancer Care Delivery “Collision course” in sight

©2010 Engage Healthcare Communications, LLCContinued on page 24

Baltimore, MD—A long-held businesstruism is that “if you can’t measure it,you can’t manage it.” The application of this belief to the oncology setting was demonstrated at a session of theAssociation of Community Cancer Cen ters’ (ACCC) 36th Annual NationalMeeting. Kimberly Bergstrom, PharmD,chief clinical officer for McKessonSpecialty Care Solutions, told attendeesof the growing importance of developingand using standardized chemotherapytreatment regimens, and of the tools that

can benchmark performance and fostercompliance with treatment guidelines.Public and private payers are mov-

ing to control exploding healthcarecosts, Dr Bergstrom told attendees,and because increased cost controlwas inevitable, it is in providers’interest to get a seat at the table. “It is an important topic, because

this is one of those things, if we don’tget a handle on it, it’s going to happento us,” she said. “People and groupsand organizations are going to startdictating how we provide cancer care,and we can’t let that happen.”

Hollywood, FL—Clinical practiceguidelines issued by the NationalComprehensive Cancer Network(NCCN) are followed by conscien-tious oncologists in their everydaypractice, but they are developedbased on clinical efficacy and withoutregard to costs. At a roundtable heldduring the NCCN’s 15th AnnualConference, moderator CliffordGoodman, PhD, Senior Vice Presidentat The Lewin Group, predicted, “Theappropriate use of evidence-basedguidelines is on a collision coursewith the financial nonsustainability ofthe healthcare system.”

Dr Goodmanalluded to a levelof frustration thathas never beenhigher in cancercare. “Too manypatients are stilldying young. Weneed innovations and a cure,” he said.But the inadequacy of current treat-ments for cancer is no longer the mainproblem. Equally challenging, he sug-gested, is finding a means to pay forthe ever-costlier care that threatens tobankrupt the healthcare system. As society struggles to find solu-

tions, “the ground is shaking beneathus,” Dr Goodman commented.

Continued on page 8



By Audrey Andrews

SEER-Medicare Database AnalysisConfirms Expensive ProstateCancers Gaining SupremacyBut cost-effectiveness of this move remains to be determined

San Francisco, CA—The popularity ofminimally invasive radical prostatec-tomy (MIRP), intensity-modulatedradiation therapy (IMRT), and ofbrachytherapy combined with IMRTfor prostate cancer started to take offafter 2002, a new database analysishas confirmed.At the American Society of Clinical

Oncology’s 2010 Genitourinary Can -cers Symposium, Paul L. Nguyen,MD, presented the results of histeam’s analysis of data from theSurveillance, Epidemiology and EndResults (SEER)-Medicare database.Dr Nguyen, director of Prostate

Brachytherapy, Dana-Farber/Brigham

and Women’s Hospital, HarvardMedical School, Boston, and his co-investigators found MIRP jumpedfrom 1.5% of radical prostatectomies(RPs) in 2002 to 28.7% in 2005. Theyalso found that IMRT soared from8.7% of external radiation treatmentsfor prostate cancer to 81.7%. In addi-

By Rosemary Frei, MSc

New Tools Arriving to Measure andManage Chemotherapy CareBusiness, clinical concerns now connected in value-focused approach By Daniel Denvir

Breast Cancer Survival Improves,Thanks to New Therapies

The 2010 Genitourinary CancersSymposium: Progress in Multi -disciplinary Management was heldMarch 5-7 in San Francisco. All ses-sions emphasized a multidisciplinaryap proach to care; a number of thembrought out the cost and value issuesassociated with caring for genitouri-nary cancers.

Value-Based Cancer Carewill be at the ASCO Annual Meeting, June 4-8, in Chicago. Please visit us at booth 18121

Barcelona—Survival for patients withmetastatic breast cancer has improveddramatically in the last 20 years, espe-cially in the subgroup of patients withHER2-positive tumors, according toresearch presented at the 7th European

Breast Cancer Confer ence (EBCC7).This improvement, the researcherssuggest, is due to in creased use ofanthracyclines and the rise of targetedtherapies.“There is no doubt that trastuzu -

mab (Herceptin), which targets theHER2 gene, is the most important

By Colin Gittens


��

Photo by © ASCO/Todd Buchanan 2009

targeted therapies


Benchmarking

Benchmarking Performance in a Physician-owned PracticeBy Teri U. Guidi, MBA, FAAMAPresident & CEO, Oncology Management Consulting Group and The Oncology Business Institute, Pipersville, Pennsylvania

With costs risingand reimburse-ments failing to

keep pace, physician prac-tices need to ensure opti-mal performance and effi-ciency. Benchmarking isintended to compare yourpractice with regional ornational standards and/orwith itself, and to evaluateyour performance overtime using objective and measurabledata elements. The point is to improveproductivity and performance: costs,revenue, throughput, etc. In general,the results are expressed in work prod-uct generated per a related resource. Forexample:• New patients per full-time equiva-lent (FTE) physician

• Total FTE staff per FTE physicianor chemotherapy nurse

• Total revenue per year or per newpatient

• Medical revenue per FTE billingstaff.

To get started, you first need to deter-mine what you will measure and com-pare. These should be measures thathold the promise of contributing to thepractice’s real performance. Choosethings that are within your power tochange and improve to the benefit ofthe practice. Don’t measure somethingjust because it is measurable or becauseyou are just curious. There is little pointin expending the time and energy tobenchmark if you are not committed to(or able to) then act on the results.Next, decide how frequently you will

measure and compare. In most cases,external benchmark data are only avail-able and updated annually. Also formany benchmarks, annual or semian-nual review is sufficient, because effect-ing changes in performance takes timeto accomplish and then time to mea -sure. Although the examples in thisarticle refer to medical oncology prac-tices, the concepts can be applied to vir-tually any physician office practice.After you have decided what you will

measure and how frequently, determinehow you will present the findings and towhom. For example: Will you developnarrative reports or graphic depictions?(See Figures 1 and 2.) Will these bedelivered without personal interactionperiodically or will they be reviewed at amonthly meeting of staff with the oppor-tunity for discussion? As when choosingwhat to measure, consider what format

and what audience combi-nation will allow identifica-tion of actionable opportu-nities for improvement.Clearly, you want to be

able to compare your ownpractice with others to findthe places where you are lesssuccessful. There are severalchallenges with using exter-nal benchmarks. As men-tioned, benchmark data are

often available only on an annual basis.In addition, it can be very difficult toensure that the external source’s defini-tion of the metric is the same as yourown. For example, if the metric refers toFTE physician, you need to be sure thatyour definition is comparable—hoursspent in clinical activities perhaps, ortotal number of new patients seen peryear or work relative value units, com-monly referred to as RVUs.Sources for external benchmark data

vary widely. Informal benchmarkingcomes from conversations at meetings,visits with colleagues, or participationin listserves. More formal sourcesinclude use of published data in the pro-fessional literature, purchased data sets,professional society surveys, member-ship in a collaborative, or subscriptionmemberships. Without spending addi-tional money, you are generally depend-ent on networking with colleagues oron published articles summarizing sur-veys for use as external benchmarks.Unfortunately, these rarely repeatthemselves one year to the next, limit-ing your ability to use them over time.Membership in professional associa-tions can provide some benchmarks aswell as networking opportunities at acost that is already being paid for thosememberships. For oncology, the poten-tial sources of benchmarking datainclude:Purchased data sets:• Medical Group Management Asso -ciation’s (MGMA) cost survey

• MGMA’s physician compensationand productivity survey.

Membership surveys:• State oncology society• MGMA’s assembly of oncologyhem atology administrators

• Association of Community Can -cer Centers.

Collaboratives/subscriptions:• Oncology Circle (physician prac-tices)

• The Oncology Business Institute(hospital outpatient services).

Figure 1. Sample Chart of Tracking and Trending of Revenue perFTE Biller and Drug Expenditures per FTE PhysicianData are fictitious and are for the purpose of illustration only.FTE indicates full-time equivalent.

Track and Trend Revenue & Drug Spending

Figure 2. Sample Chart of Tracking and Trending of New Patientsper FTE Physician and Infusion Encounters per FTE ChemotherapyNurse Data are fictitious and are for the purpose of illustration only.FTE indicates full-time equivalent.

Track and Trend New Patients & Infusion

New patients/FTE Physician

Infusion encounters/FTEChemotherapy Nurse

New patients: benchmark

Infusion encounters: benchmark

Revenue/FTE BillerDrug spend/FTE PhysicianRevenue: benchmarkDrug spend: benchmark

Teri U. Guidi, MBA, FAAMA

Publications:• Hematology & Oncology News &Issues• Journal of Oncology Practice• Oncology Business Review• Oncology Issues.Equally important to external compar-

ison, however, is measuring your ownperformance over time—especially if youalready “beat” the benchmark. The goalis continuous improvement, not justbeing assured that you are doing as wellas everyone else. You are looking for aconsistent trend in a positive direction.After your first round of measuring,

examine each point that you haveincluded. Does your performance leaveroom for useful change? If not, decidewhether repeating this metric is worth-while or if another should be substitut-ed. If useful change is possible, bringtogether the needed individuals toensure that all understand the metricand then to develop and implement anaction plan and accompanying targetsfor future performance.For example, if you have chosen as a

metric “pharmacy dollars spent per FTEphysician,” and if your performance isworse than desired (perhaps anythingbelow mean or median in the bench-mark data), your team would includeone or more physicians, the individualresponsible for drug-purchasing deci-sions (quantities, vial sizes, schedule,days inventory turn, etc), and individ-ual(s) responsible for choosing vials andmixing/wasting drug. This team mayneed to do some research to fully under-stand the impact of their relationshipsto the outcomes. Then, the team canbrainstorm ways to reduce the totaloncology spend as well as the cost andquantity of drugs on hand (tying upcash and frequently resulting in unin-tended waste).As another example, perhaps you

have chosen “medical revenue per FTEbiller.” This multifaceted issue has manycontributing factors. Are your charge-capture processes missing any billableitems? Does your charge-entry systeminterface correctly with the billing sys-tem or are items inadvertently omitted?Does the billing system receive all therequired information to produce a cleanclaim? Are you collecting according tocontract or are items going unpaidunnecessarily? Does your billing and col-lections staff spend unnecessary timeresubmitting and appealing? Are yourcontracts as favorable as possible? Onlyafter answering these questions can youfocus on the possibility that you simplyhave too many staff members in thebilling department.By now it should be obvious that you

will need a system for regularly calculat-ing your performance. At its simplest,this might be a person who understandsyour practice management and elec-

tronic health record systems and whocan set up relatively simple spreadsheetsor other tools to track and report results.Your own internal sources of data willvary, but likely will include:• Procedure productivity report fromyour practice management system.This can be used for almost all pro-

ductivity measures, because it willinclude volume of Current ProceduralTerminology (CPT) codes, units ofservice, and collected revenue.

• Additional financial reports providedata on income, staffing costs, oper-ating expense, drug costs, etc.

• Human resource records add to the

mix the information on FTEs in var-ious roles.In the final analysis, the two most

important things are to systematicallyand regularly track your own perform-ance over the course of time and to acton the results, formulating and imple-menting plans for improvement. l


Benchmarking

There is A place you can go for user-friendly online tools and reimbursement forms…

…where your coverage questions can be Answered

…where online Access to forms is simple

…where you can talk to A reimbursement specialist directly

For insurance verifi cation…prior authorization…patient assistance program information…and billing and claims processing support.

Making Access easier.

with new enhanced online services

Amgen Assist™ and Amgen Inc. do not guarantee success in obtaining reimbursement. Third party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or resolved by our Amgen Assist™ staff.©Amgen. All rights reserved. MC48319 11/09

www.amgenassist.com1-800-272-9376


Medications Used for the Treatment of Colorectal Cancer

Current MedicareFDA- code price allowableapproved Compendia listed (AWP-based (ASP + 6%), CPT®

generic (Brand) HCPCS code: for colorectal off-label use for pricing), effective effective administrationname code description cancer colorectal cancera 7/1/10 7/1/10-9/30/10 codes

bacillus J9031: bCG (intravesical), ✓ $169.10 $110.31 96413, 96415Calmette-Guerin per installation(Tice BCG, TheraCys)bevacizumab J9035: injection, ✓ $66.99 $58.45 96413, 96415(Avastin) bevacizumab, 10 mgcapecitabine J8520: capecitabine, ✓ $8.52 $6.86 96413, 96415(Xeloda) oral, 150 mgcapecitabine J8521: capecitabine, ✓ $28.41 $22.48 96413, 96415(Xeloda) oral, 500 mgcarmustine J9050: injection, ✓ $205.69 $176.15 96413, 96415(BiCNU) carmustine, 100 mgcetuximab J9055: injection, ✓ $57.60 $49.73 96413, 96415(Erbitux) cetuximab, 10 mgcisplatin J9060: cisplatin, ✓ $4.33 $1.89 96409, 96413, 96415(Platinol AQ) powder or solution, per 10 mgcisplatin J9062: cisplatin, ✓ $21.66 $9.45 96409, 96413, 96415(Platinol AQ) 50 mg

O N C O L O G Y D R U G C O D E SSupplied by: RJ Health Systems

Colon cancer forms in the tissues of the colon (thelongest part of the large intestine). Most coloncancers are adenocarcinomas (cancers that beginin cells that make and release mucus and other flu-ids). Rectal cancer forms in the tissues of the rec-tum (the last several inches of the large intestineclosest to the anus). The following sections willassist healthcare professionals and payers by pro-viding appropriate coding, billing, and reimburse-ment information associated with the manage-ment of colorectal cancer.

The following sections include:• Associated ICD-9-CM codes used for theclassification of colorectal cancer

• Drugs that have been FDA-approved in thetreatment of colorectal cancer

• Drugs that are Compendia listed for off-labeluse for colorectal cancer based on clinicalstudies that suggest beneficial use in somecases. Please note: if a check mark appearsin the FDA column it will NOT appear inthe compendia off-label use column

• Corresponding HCPCS/CPT® codes and code descriptions

• Current Code Price (AWP-based pricing)• Most recent ASP plus 6% (Medicare allow-able), if applicable

• Possible CPT® Administration Codes foreach medication

Associated ICD-9-CM Codes Used for Colorectal Cancer153 Malignant neoplasm of colon

Excludes: benign carcinoid tumor of colon (209.50-209.56)malignant carcinoid tumor of colon (209.10-209.16)

153.0 Hepatic flexure153.1 Transverse colon153.2 Descending colon

Left colon153.3 Sigmoid colon

Sigmoid (flexure)Excludes: rectosigmoid function (154.0)

153.4 CecumIleocecal valve

153.5 Appendix153.6 Ascending colon

Right colon153.7 Splenic flexure153.8 Other specified sites of large intestine

Malignant neoplasm of contiguous or overlapping sites of colon whose point of origin cannot be determinedExcludes: ileocecal valve (153.4)

rectosigmoid junction (154.0)153.9 Colon, unspecified

Large intestine, not otherwise specified154 Malignant neoplasm of rectum, rectosigmoid junction, and anus

Excludes: benign carcinoid tumor of rectum (209.57)malignant carcinoid tumor of rectum (209.17)

154.0 Rectosigmoid junctionColon with rectumRectosigmoid (colon)

154.1 RectumRectal ampulla

154.8 OtherAnorectumCloacogenic zoneMalignant neoplasm of contiguous or overlapping sites of rectum, rectosigmoid junction, and anus whose point of origin cannot be determined



Current MedicareFDA- code price allowableapproved Compendia listed (AWP-based (ASP + 6%), CPT®

generic (Brand) HCPCS code: for colorectal off-label use for pricing), effective effective administrationname code description cancer colorectal cancera 7/1/10 7/1/10-9/30/10 codes

doxorubicin J9000: injection, ✓ $13.20 $2.94 96409(Adriamycin) doxorubicin hydrochloride, 10 mgfloxuridine J9200: injection, ✓ $121.06 $43.10 96422, 96423, 96425(FUDR) floxuridine, 500 mgfluorouracil J9190: injection fluorouracil, ✓ $3.37 $1.48 96409(Adrucil) 500 mgirinotecan J9206: injection, ✓ $31.48 $6.79 96413, 96415(Camptosar) irinotecan, 20 mgleucovorin calcium J0640: injection, ✓ $3.60 $0.95 96372, 96374, 96409(Wellcovorin) leucovorin calcium,

per 50 mglevoleucovorin J0641: injection, ✓ $1.54 $0.65 96365, 96366calcium levoleucovorin calcium, 0.5 mg(Fusilev)lomustine J8999b: prescription drug, ✓ NDC NDC N/A(CeeNu) oral, chemotherapeutic, level level

not otherwise specified pricing pricinglomustine S0178: lomustine, ✓ $10.59 S0178: not N/A(CeeNu) oral, 10 mg payable by

Medicaremethotrexate J9250: methotrexate sodium, ✓ $0.29 $0.19 96372, 96374, 96401,sodium 5 mg 96409, 96450methotrexate J9260: methotrexate sodium, ✓ $2.86 $1.92 96372, 96374, 96401, sodium 50 mg 96409, 96450mitomycin J9280: mitomycin, 5 mg ✓ $67.20 $20.19 96409(Mutamycin)mitomycin J9290: mitomycin, 20mg ✓ $218.40 $80.74 96409(Mutamycin)mitomycin J9291: mitomycin, 40 mg ✓ $300.00 $161.48 96409(Mutamycin)mitoxantrone J9293: injection, ✓ $106.50 $40.88 96409, 96413(Novantrone) mitoxantrone hydrochloride,

per 5 mgoxaliplatin J9263: injection, ✓ $8.25 $4.46 96413, 96415(Eloxatin) oxaliplatin, 0.5 mgpanitumumab J9303: injection, ✓ $101.85 $87.24 96413, 96415(Vectibix) panitumumab, 10 mgpemetrexed J9305: injection, ✓ $60.67 $51.69 96409(Alimta) pemetrexed, 10 mgteniposide Q2017: injection, ✓ $376.55 $324.27 96413, 96415(Vumon) teniposide, 50 mgtopotecan J8705: topotecan, ✓ $89.73 $74.59 N/A(Hycamtin) oral, 0.25 mgtopotecan J9350: injection topotecan, ✓ $1,306.10 $1,058.74 96413(Hycamtin) 4 mgvinCRIStine J9370: vincristine sulfate, ✓ $7.22 $4.53 96409(Vincasar) 1 mgvinCRIStine J9375: vincristine sulfate, ✓ $14.44 $9.06 96409(Vincasar) 2 mgvinCRIStine J9380: vincristine sulfate, ✓ $36.10 $22.65 96409(Vincasar) 5 mg




PO BOX 290616, Wethersfield, CT 06109 T: (860) 563-1223 • F: (860) 563-1650

www.RJHealthSystems.com

This information was supplied by:

aCompendia references available upon request.bWhen billing a non-classified medication using a CMS 1500 claim form you must include both the HCPCS code (ie, J8999 for CeeNu) in Column 24D and the drug name, strength, and National DrugCode (NDC) in Box 19 in order to ensure appropriate reimbursement.

ReferencesHCPCS Level II Expert 2010 • Current Procedural Terminology (CPT®) 2010 • ICD-9-CM for Professionals Volumes 1 & 2 2010 • The Drug Reimbursement Coding and Pricing Guide by RJ HealthSystems International, LLC, Volume 7, Number 3, 3rd Quarter 2010 • FDA-approved indication (from product’s prescribing information) • National Cancer Institute® • www.ReimbursementCodes.compowered by RJ Health Systems International, LLC, Wethersfield, Connecticut • CMS (Centers for Medicare & Medicaid Services)—Medicare Allowable 3rd Quarter 2010 (effective dates 7/1/10-9/30/10).

Prices listed herein are effective as of July 1, 2010.

ASP indicates average sales price; AWP, average wholesale price; CMS, Centers for Medicare & Medicaid Services; CPT®, Current Procedural Terminology; FDA, US Food and Drug Administration;HCPCS, Healthcare Common Procedure Coding System; NDC, National Drug Code.


PSYCHOSOCIAL ISSUES

father’s cancer diagnosis, emphasizedthe value of hospice services for an olderwidow recently referred to hospice,established rapport with a new patientand her husband by commenting onhow the husband’s nonverbal behaviorsanswered the physician’s question evenbefore the patient answered them (ahumorous bonding moment for coun-selor and couple), and stood next to afavorite longtime patient when he wastold that his cancer had recurred. Manycounselors have referred to their work

at SCTRC as a “gift,” and counselor sat-isfaction with their SCTRC experienceis high.

How to develop a teamOur model of a counseling team is

novel, practical, and could serve as aprototype for other cancer centers andcommunity oncology practices.2 On -cology practices could partner with alocal college or university, most ofwhich would have undergraduate/grad-uate programs in psychology, counsel-ing, or social work. Students in suchprograms are commonly required to par-ticipate in practica or externships in acommunity agency or other setting. A cancer center is a perfect setting,

given the right preparation for bothstudents and practicum site. Often apracticum site will provide supervisionfor the practicum students. If that isnot available, by providing really goodtraining for students, a site would like-ly obtain supervision from the academ-ic unit whose students it trains.The process of arranging such a part-

nership is not difficult. It simply requiresdue diligence, excellent communica-tion, mutual respect, and the sharedgoal of providing training opportunitiesfor psychosocial professionals andimproving psychosocial cancer care forpatients and their families and care-givers. The goals are worthwhile andachievable. l

References1. Institute of Medicine Committee on Psychosocial

Services to Cancer Patients/Families in a Com -munity Setting; Adler NE, Page AEK, eds. CancerCare for the Whole Patient: Meeting PsychosocialHealth Needs. Washington, DC: The NationalAcademies Press; 2008.

Nurses receive both medical andinterpersonal skills training. I havecome to view most patients whohave a cancer diagnosis as remark-able. They endure difficult treat-ment and sometimes worry moreabout others, like spouses, than theydo about themselves. Sometimes aspouse is more stressed about thepatient’s condition; sometimes aspouse is less accepting of the realityof how the patient is doing. I believethat nurses do a good job medicallyand interpersonally in spite of limit-ed time and resources, but patientsand their families are often in deepemotional distress. The counselorshelp patients and families directly.In addition, partnering with thecounselors helps me help eachpatient more effectively. We reallyare a team.

—Vassia Craddick, RCN, BSNNurse Director of Clinical

Services

A Team Approach...continued from page 20 Recent FDA ApprovalsCabazitaxel for MetastaticProstate CancerThe US Food and Drug Admin -

istration (FDA) has approved cabazi-taxel (Jevtana injection, sanofi-aven-tis) for use in combination withprednisone for treatment of metastatichormone-refractory prostate cancer(mHRPC) previously treated with adocetaxel-containing regimen. Ap -proval was based on results from a ran-domized, open-label, internationaltrial of 775 men with mHRPC previ-ously treated with docetaxel-contain-ing regimens who received intravenouscabazitaxel in combination with pred-nisone or intravenous mitoxantrone incombination with prednisone. Themedian overall survival for patientsreceiving the cabazitaxel regimen was15.1 months compared with 12.7months for those who received themitoxantrone regimen. Cabazitaxelwas reviewed under the FDA’s priorityreview program.

Ondansetron Oral Soluble Film forCancer-related Nausea andVomitingThe FDA has approved ondan -

setron (Zuplenz, Strativa) oral solublefilm for the prevention of postop -e rative, highly and moderately eme -togenic chemotherapy-induced andradiotherapy-induced nausea and vom-iting. Approval was granted based onstudy results that showed the bioequiv-alence of ondansetron 8 mg oral solu-ble film to 8 mg orally dissolving tablet.The formulation, the first oral soluble

film approved by the FDA as a pre-scription medicine, can be taken withor without water and under fed or fast-ing conditions. This formulation meetsthe needs of patients in which watercauses discomfort.

Nilotinib for Newly DiagnosedChronic Myeloid LeukemiaThe FDA has approved nilotinib

(Tasigna, Novartis) for the treatmentof adult patients with newly diagnosedPhiladelphia chromosome–positivechronic myeloid leukemia (Ph+ CML)in chronic phase (CP-CML). The rec-ommended nilotinib dose for this indi-cation is 300 mg orally twice daily.Tasigna has been approved since 2007for the treatment of adult patients withCP-CML in accelerated phase (AP-CML) resistant or intolerant to priortherapy that included imatinib. Ap -proval was based on data from theENESTnd, a phase 3, open-label, mul-ticenter trial. Major molecular re -sponse at 12 months was achieved in22% (95% CI, 18-28) of patients inthe imatinib arm, 44% (95% CI, 38-50) in the nilotinib 300-mg twice-dailyarm, and 43% (95% CI, 37-49) in thenilotinib 400-mg twice-daily arm.Complete cytogenetic response ratesby 12 months were 65% (95% CI, 59-71) for the imatinib arm, 80% (95%CI, 75-85) for the nilotinib 300-mgtwice-daily arm, and 78% (95% CI,73-83) for the nilotinib 400-mg twice- daily arm. This indication was re -viewed under the FDA’s priorityreview program. l

Current activities at www.COEXM.com include:

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Cancer Center Profile

ic groups, some of whom are uninsuredor underinsured.But the staff believes they can do bet-

ter. For example, radiation oncology“has advanced radiation treatmentequipment for patient care,” LawrenceJ. Solin, MD, FACR, FASTRO, chair,Depart ment of Radiation Oncology,told the Journal of Multi disciplinaryCancer Care. “It is extremely importantto make sure that our patients not onlyhave access to treatment, but that weprovide them with the support servicesto complete their prescribed therapy.”To help patients do that, Einstein plansto expand its nutrition, dietary, andsocial services for patients undergoingradiation oncology.These expansions will go well beyond

radiation oncology. “For those patientsthat are starting chemotherapy for thefirst time, we have developed what wecall a patient teaching appointment.The patient comes in and has one-on-one time with a social worker, a treat-ment nurse, and a dietitian,” said TiffanyRaroha, MSW, one of two oncologysocial workers at Einstein. The center’splan is to reach every patient starting anew cancer treatment, expanding socialservices not only to radiation oncologypatients but also to surgical oncologypatients. “We plan to be more proactivewith doing psychosocial assessments upfront with newly diagnosed patients aswell as being able to do continuous fol-low-up of their psychosocial needs,” saidRaroha. Einstein also plans to addpatient navigators to help patients getthrough the system more easily.

Enhancing qualityFor more than 20 years, Einstein has

employed site-specific multidisciplinarycancer programs. For most disease sites,physicians and support staff meet anddiscuss all new cases as well as caseswhere a problem has arisen or a patient

has a recurrence. These groups includemore than just the medical, surgical, andradiation oncologists. In addition tothese oncologists, for example, the lungcancer program has regular attendanceby its thoracic surgeon, its pulmonolo-gist, a research nurse, social services, anda pathologist, according to Tester. In thebreast health program, 15 to 20 peoplemeet every Wednesday, including repre-sentatives from breast surgery, medicaloncology, radiation oncology, radiology,pathology, plastic surgery, genetics, andrehabilitation. “This is a great way toinvolve all the experts, so when apatient returns for her 1-week checkupafter completing her surgery, and I tellher that she needs to see the medicaloncologist, that physician has already

fully reviewed her case. I can tell thepatient what the medical oncologistplans on giving her and which trials willbe available to her,” said Lisa Jablon,MD, FACS, a breast surgeon who isdirector of the Breast Health Program.At present, Einstein has multidiscipli-nary programs in breast cancer, lungcancer, gastrointestinal cancer, andhematologic malignancies, and hopes todevelop an active urologic program withthe NCCCP funding.To integrate care further, Tester has

one initiative he is excited about thepossibility of implementing now thatEinstein is an NCCCP cancer center.“What we could do with NCCCP sup-port is bring the patient into the multi-disciplinary conferences. We havealways discussed cases, reviewed pathol-ogy, radiologic imaging, and clinical tri-als that would be appropriate, but wehave never actually brought the patientinto the discussion room. Multidis -ciplinary care is an initiative that isimportant to the NCCCP, and we areplanning and want to make that work.At the very least, we want to have amultidisciplinary clinic that meets afterthe tumor board meeting where thepatient could actually meet three or fourof the clinicians involved in his or her

care. The presence of the patient willshow him or her that our approach istruly multidisciplinary, and that his orher personal issues and input are consid-ered in making final treatment deci-sions.”In addition, Einstein plans to incorpo-

rate more survivorship services. “Ourplan is to offer survivorship strategies toall patients at the time of diagnosis andcontinue that through and beyond treat-ment,” said Tester. The NCCCP grantallows Einstein to hire a coordinator torun survivorship services. Jablon provid-ed an illustration of how this wouldwork in breast health: “We do have anactive cancer program and social work-ers. Plus, different organizations like theAmerican Cancer Society offer a lot ofprograms that are integrated with ourlocal hospital, such as Reach toRecovery and Look Good…Feel Better.We would like to make survivorshipeven more of a focus for our patientsafter they have passed through their pri-mary treatment. For example, I just gotback from a conference where theytalked a lot about how we don’t inte-grate improvements in exercise orweight control into our cancer popula-tion. Even though we tell our patientsthat they need to lose weight, we offerno specific, active programs for them togo out and do that. One of my thoughts

is to go out into the community andorganize walking groups of cancer sur-vivors and people interested in cancerprevention to integrate exercise into thecommunity practice.”

Clinical trials and biospecimenresearchEinstein has been active in clinical

trials since it was originally funded bythe NCI in 1972. “We have always hada strong commitment to offeringpatients state-of-the-art clinical trials,and I think that is exemplified by thearray of clinical trials we offer throughthe Eastern Cooperative OncologyGroup (ECOG), the Radiation TherapyOncology Group (RTOG), and theNational Surgical Adjuvant Breast andBowel Project (NSABP),” Solin said.“One of the things we would like to dois enhance access to clinical trials for ourpopulation through the NCCCP grant.”Biospecimen collection, however, will

be something new. “We have done a lotof clinical work at Einstein but not asmuch in the basic science arena,” saidTester. “But with the NCCCP to sup-port our collection of biospecimens, weare going to be creating our own tissuebank, and we are going to be able to beinvolved in more translational researchactivities.” For example, Einstein cur-rently works in collaboration withThomas Jefferson University, which hasa strong basic science program andtranslational research. Tester believesthat Einstein’s involvement in thosetypes of research “could increase as weput aside tumor specimens and shipthem for special molecular studies, andthen tie that into clinical trials wherewe are going to evaluate the effect ofcertain new targeted therapies onpatients according to which moleculesare expressed by their tumors. With theassistance of Corrado Minimo, MD, andour pathology department, we plan todevelop a strong biomarker program.”

To the future“Cancer affects not just the patient

but the entire family as a unit. So ourhope is to expand our program to meetthe needs of not just the patient but thefamily unit. We are hoping we can pro-vide a bereavement program for familiesof those unfortunate patients who losethe battle to cancer and, possibly, someprograms that will meet the needs ofchildren whose parents have cancer,”Raroha said. l

Albert Einstein Cancer Center...continued from cover

Dr William Tester, a medical oncologist, and Tiffany Raroha, an oncology socialworker, counsel a patient.

“Multidisciplinary care is an initiative that is importantto the NCCCP, and we are planning and want tomake that work. At the very least, we want to have a multidisciplinary clinic that meets after the tumor board meeting where the patient couldactually meet three or four of the clinicians involved in his or her care.”

——William J. Tester, MD, FACP

Albert Einstein Medical Center5501 Old York RoadPhiladelphia, PA 19141 Einstein Center One9880 Bustleton Avenue Philadelphia, PA 19115

TARGET AUDIENCEThis activity is intended for hematologists, oncologists and other healthcare professionals who are involved with the care of patients withfollicular lymphoma.

STATEMENT OF NEEDNon-Hodgkin's lymphoma (NHL), the most common hematologicmalignancy, represents a large proportion of the case load for the typicaloncology practitioner. That load is likely to grow, since NHL is increasingin prevalence. The introduction of rituximab, the monoclonal antibodyagainst CD20, changed the treatment landscape of lymphoma and it has been advanced further by immunotherapies that combine CD20-directed targeting with radiotherapy. The recent rapid advances intherapeutics and impressive research across this broad, heterogeneousgroup of malignancies represent an educational challenge for the clinician trying to stay current and provide the most appropriate, up-to-date therapy tailored for the individual patient. Immunotherapyplays a key role at all stages of the disease in reaching the goal of thehighest quality response.

EDUCATIONAL OBJECTIVESOn completion of this activity, participants should be able to:

• Define the goals of therapy for follicular lymphoma (FL)• Describe strategies for patient selection for immunotherapy(including radioimmunotherapy [RIT]), in both the up-front andrelapsed/refractory setting

• Define different immunotherapy approaches in terms of efficacy,safety, and tolerability

• Propose strategies to overcome adverse events and access issues thatcreate barriers to the provision of optimal immunotherapy in FL

The Essential Role of Immunotherapy in Follicular Lymphoma Management

www.coexm.com/ace03.aspLOG ON TODAY TO PARTICIPATE

Release Date: March 19, 2010 Expiration Date: March 18, 2011

In collaboration with

FACULTYStephanie A. Gregory, MDProfessor of MedicineDirector, Section of HematologyRush University Medical CenterChicago, Illinois

David Maloney, MD, PhDAssociate Professor of MedicineDivision of OncologyUniversity of WashingtonMember Fred Hutchinson Cancer Research Center Seattle, Washington

With commentary by:Peter S. Conti, MD, PhDProfessorNuclear MedicineKeck School of MedicineUniversity of Southern CaliforniaLos Angeles, California

This activity has been approved for 1.0 AMA PRA Category 1 Credits™. For further information and to participate, please go to: www.coexm.com/ace03.asp

This activity is supported by an educational grant from Spectrum Pharmaceuticals.

Today, he got the cancer treatment he needed.Along with a healthy dose of peace of mind.

A cancer diagnosis gives a patient a lot to worry about. The truth is, it can also cause treatment concerns for physicians as well as reimbursement and coverage issues for practice administrators and insurers. Call us or visit our Web site to learn how we can partner with you to simplify it all. It’s the kind of support you need, while patients receive the treatment they need. For more information, visit www.LillyPatientOne.com or call 1-866-4PatOne (1-866-472-8663).

Lilly Oncology

Patient Assistance Insurance Expertise Claim Appeals

1-866-4PatOne

MQ43286 0807 PRINTED IN USA © 2009, Lilly USA, LLC. ALL RIGHTS RESERVED.

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