Increasing Mastectomy Rates:Science vs. Personal Choice

Deanna J. Attai, MD, FACSAssistant Clinical Professor of Surgery

David Geffen School of Medicine at UCLAPresident, American Society of Breast Surgeons

@DrAttai

January 2016Rush University Medical Center

No Disclosures

History of Breast Cancer Surgery

A German physician warned surgeons about the procedure: "Many females can stand the operation with the greatest courage and without hardly moaning at all. Others, however, make such a clamor that they may dishearten even the most undaunted surgeon and hinder the operation. To perform the operation, the surgeon should be steadfast and not allow himself to become discomforted by the cries of the patient."

Olson, J: “Bathsheba’s Breast: Women, Cancer and History”

Sir William Halsted• 1840’s – General Anesthesia• Halsted Radical mastectomy• Standard treatment 1890-

1960s• Aggressive surgical treatment

for what was usually locally advanced disease

• No improvement in survival

• Halsted died in 1922….

CANCER

LYMPH NODES

LUNGS

LIVER

HALSTED THEORY

BONE

Radical Mastectomy

CANCER

LYMPH NODES

FISHER THEORY

LUNGS

LIVER

BONE

BLOOD STREAM

Dr. Bernard FisherNSABP B04 Enrollment 1971-1974

www.NSABP.edu

Fisher B et al. NEJM2002;347:567-575

NSABP B04 Results

• Preservation of the pectoral muscle new standard of care• 2 step procedure should be performed

Modified Radical Mastectomy

Modified Radical Mastectomy

The 1970-80s

• Screening mammography became more prevalent

• Smaller cancers detected

• Increased public awareness• Betty Ford• Shirley Temple Black• Happy Rockefeller

NSABP B06 Enrollment 1976-1984

www.NSABP.edu

NSABP B06 Results

Fisher, et al NEJM2002 Vol. 347, No. 16

NSABP B06 Results

•Higher local recurrence without post-lumpectomy radiation:

39.2% vs. 14.3%

Fisher, et al NEJM2002Vol. 347, No. 16

1990 NIH Consensus Statement

“Breast conservation treatment is an appropriate method of primary therapy for the majority of women with early-stage breast cancer and is preferable because it provides survival rates equivalent to those of mastectomy while preserving the breast’’

NIH consensus conferenceTreatment of early-stage breast cancer

JAMA. 1991;265:391–5

Targeting the Cancer

Goals of Breast Conservation

• Minimize local recurrence at the primary site

• Achieve an acceptable cosmetic result

• Eradicate microscopic foci of cancer with radiation

• Minimize risk of complications

• Maximize benefit in terms of quality of life

The Celebrity Effect – Nancy Reagan 1987

• Criticized for undergoing one-stage mastectomy

• “This is a very personal decision, one that each woman must make for herself. This was my choice, and I don’t believe I should have been criticized for it”

Olson, J: “Bathsheba’s Breast: Women, Cancer and History”

The Nancy Reagan Effect

• SEER Database 1983-1990

• 25% less likely to undergo BCS Q3 1987 vs. Q4 1987, Q1 1988

• Celebrity role models can influence decisions about medical care

Nattinger AB, et al JAMA 1998 (279) 10 762-766

Age ≥ 30

Age 65-79

Women’s Health and Cancer Rights Act of 1988

• Health plans offering mastectomy coverage must provide:• Reconstruction of the breast on which mastectomy performed• Surgery, reconstruction of the other breast to produce a symmetrical appearance

• Treatment of physical complications of mastectomy, lymphedema• Prostheses

• Cannot deny coverage to avoid requirements; cannot penalize or limit reimbursement to provider

Reconstruction Trends 1998-2011

Kummerow KL, et al JAMA Surg doi:10.1001/jamasurg.2014.2895

SEER 1994-2008

• Initial increase in lumpectomy rates after B06

• 2004 – increase in mastectomy rates

McGuire KP, et al Ann Surg Oncol2009 16:2682-2690

University of Louisville 1995-2008

• Increasing use of elective mastectomy, immediate reconstruction, and CPM in breast conservation candidates

Dragun AE, et al Am J Clin Oncol 2013;36:375–380

Mastectomy rate by age at diagnosisSEER 2000-2008

Mahmood U, et al Ann Surg Oncol2013 20:1436-1443

SEER 1998-2008 CPM Rates

• Factors: Young age, Caucasian, invasive lobular

• Patients with unilateral BC have options less extreme than CPM

• Call for further study to determine reasons for increasing rates

Tuttle TM, et al J Clin Oncol 2007 25:5203-5209

CPM: National Cancer Data Base 1998-2007

• 1.6 million patients• CPM increased 10 fold: 0.4 4.7%

regardless of age, stage, histology, insurance, income, facility volume

• Caucasian women <40, high income, access to quality insuranceYao K, et al Ann Surg Oncol

2010(17) 2554-2562

MSKCC: Increasing CPM with MRI

• 1997-2005 CPM 3x• Only 13% high risk

• Gene mutation, mantle irradiation• Factors:

• Young age• Family history• Genetic testing• Preoperative MRI• Availability of reconstruction• Unsuccessful attempt at conservation

King TA, et al J Clin Oncol 29:2158-2164 97-2005

Influence of Preoperative MRI

• Meta-analysis of Surgical Outcomes• 9 eligible studies, 3112 patients• Initial mastectomy 16.4 vs 8.1% (p<0.001)

• Retrospective cohort study evaluating preoperative MRI• Mastectomy odds ratio 1.73• CPM odds ratio 1.48

Houssami N et al Ann Surg 2013 257(2):249-255.

Arnauot A et alJAMA Oncol 2015;1(9):1238-1250

NSM / Implant

NSM / DIEP

Facts: CBC and Survival

• CBC rate 0.4-0.75% per year, ~4-5% at 10 years• CBC decreased with adjuvant therapy• Modest association between CPM and DFS in small studies• Minimal data showing CPM results in improved OS • CPM no effect on metastatic disease

Rosenberg SM, et al Ann Intern Med 2013;159:373-381

Angelos P, et al Ann Surg Oncol2015 22:3208–3212

Portschy PR, et al Ann Surg Oncol2015 22:3846–3852

Facts: CPM Not Cost Effective

• CPM is cost-saving for the prevention of CBC in women younger than 50 years of age with sporadic, unilateral early stage breast cancers, but also impacts health

• Cost savings are insufficient (given impact on overall health) to be considered cost-effective

Roberts A et al Ann Surg Oncol2014 21:2209-2217

Facts: Surgical Complications

• ACS NSQIP Analysis of 11,645 patients• SM with Implant vs BCS - low 30-day complication rates

• Total complication: 5.5% vs 2.1% • Wound complication 2.8% vs 1.4%• Infection 1.9% vs 0.4%• Bleeding 0.2% vs 0.05%

Pyfer B, et al Ann Surg Oncol 2016 23:92-98

Facts: Surgical Complications• University of Chicago – UBC 2009-2012• 660 patients CPM vs. UM• Major vs Minor complications• Overall complications 41.6 vs. 28.6% • Major complications 13.9% vs. 4.1%

Miller ME et al Ann Surg Oncol2013 204113-4120

Facts: Surgical Complications and Cost• MarketScan (44,344) and SEER-Medicare (50,562)• MarketScan: 29% BCS+WBI vs 54% MR• SEER-Medicare: 37% BCS+WBI vs 65% MR

• MR vs BCS+WBI mean adjusted complication related cost • +$8085 MarketScan • +$3711 SEER-Medicare

• Total cost MR in MarketScan $77,321 • $15,181 more than BCS

Smith BD et al 2015 SABCS Oral Abstracthttp://www.abstracts2view.com/sabcs15/view.php?nu=SABCS15L_508&terms=

Risk Perception, Education, Control • Overestimation of risk• Despite knowing CPM does not impact survival, women

have procedure in part to extend lives - discordance• MD most important information source but only 1/3 cited

desire to follow MD recommendation as important factor in decision

• Seek to take control of cancer, manage fear• Exaggerated control beliefs “never happen again”• Impact of friend/family experience Covelli AM, et al Ann Surg Oncol

DOI 10.1245/s10434-014-4033-7

Rosenberg SM, et al Ann Intern Med 2013;159:373-381

Risk Perception, Education, Control• 10 year risk estimate:

• 35.7% for CPM vs 13.8% for non-CPM

• CPM patients: 100% strongly agreed right decision• Non-CPM 88% strongly agreed right decision• Important educational resource:

• 88% MD• 58% Family• 33% Friends• 21% internet

Portschy PR, et al Ann Surg Oncol2015 22:3846–3852

Risk Perception, Education, Control

• Emotional factors – anxiety, fear of recurrence• Women who had CPM reported less worry about cancer

coming back, expressed greater confidence with decision

• Interventions that enhance risk communication, reduce anxiety and encourage shared decision making may be beneficial

Rosenberg SM et al Ann Surg Oncol2015 22:3809–3815

Risk Perception, Education, ControlPatient-Driven Decision

Rosenberg SM et al Ann Surg Oncol2015 22:3809–3815

Long Term Satisfaction

• Mayo Clinic: 583 UBC CPM patients 1960-1993• Initial survey at 10 years; 487 re-surveyed at 20 years

• 93% felt made an informed decision• 90% satisfied, 92% would choose again

• 10-30% had issues with self-esteem, body image, sexual relationships, emotional stability

Frost MH, et al Ann Surg Oncol2011 18:3110-3116

We Are Partly To Blame

• ASBrS Survey - 592 responses (24.3%)• Assessed knowledge about CPM• 60.8% demonstrated high level, 39.2% low level knowledge• Duration of practice, fellowship training significant predictors of

high level knowledge

• Unclear how knowledge translates into treatment patterns• Surgeons need training on how to effectively counsel patients

Yao K et al. JAMA SurgeryPublished Online November 25, 2015

Doi:10.1001/jamasurg.2015.3601

What do the Patients Say?• If you had mastectomy for early stage cancer or CPM: why,

did doctor discuss, are you happy with decision?

• Blog post, Twitter, Facebook• Patients could respond in public forum or via email• 56 responses over 2 weeks

What do the Patients Say?“I wish doctors, researchers and the media understood (some do) – there are many valid reasons for choosing a mastectomy, even with the state-of-science today” - Retired pathologist

“The focus is on ‘simple’ surgery - the potential toxicity of radiation therapy is grossly minimized. While serious and long-term side effects of radiation therapy may be rare, they do occur. It is ironic now that patients have a choice in treatment selection, there is so much hand-wringing by the medical establishment in the choices that many women make”. – OR nurse

What do the Patients Say?

“We are diligent. We are thoughtful. We have good reasons for choosing the “big surgery”. Our doctors explain the risk factors, we process the information, we understand the full ramifications of our choice, and are still confident that this is the right choice for our set of circumstances.

It may not fit the medically necessary criteria, but it may fit with the emotionally necessary criteria. I hear your evidence based science and I’ll raise you five intangibles…”- Patient / Advocate

Summary Of Contributing Factors• Caucasian, <40• Higher income, education, insurance• Family history, Genetic testing• Use of MRI• Availability of reconstruction• Lobular histology• Failed BCS• Fear, over-estimation of risk, impact of personal

experience• MD education

What Can We Do?

• Stop the hand-wringing

• 1950-70’s – limited awareness, mastectomy was barbaric• Present – everyone knows someone, awareness of

recurrence, radiation complications, improved reconstruction

• Quick fix society• Celebrity effect, pressure from family/friends• Era of shared decision making / move away from paternalism

What Can We Do?

• Most are satisfied w/decision but less so w/cosmetic outcome - morbidity and complications need to be addressed

• Stress that there is time to make an informed decision• Address actual risk; risk reduction, no reduction in mortality• Ensure psychosocial support throughout the process

• Risk / benefit decision tools may reduce possibility of overtreatment

• MD guilty of providing large amount of information but insufficient context • Better education: risk of CBC, costs/benefits of CPM, alternatives

2010 Cochrane Reviewhttp://www.thecochranelibrary.com

Hawley ST, et al JAMA Surg doi:10.1001/jamasurg.2013.5689

Fayanju O et al Ann Surg2014; 260:1000-1010

What Can We Do?

• Correct knowledge deficits• Ongoing clinical trials assessing decision making tools

• Even if treatment choice not impacted, patient satisfaction increases with use of a decision tool

• Comprehensive strategy that focuses not just on the development of tools that promote shared decision making but also addresses knowledge deficits and manages anxiety

Bedrosian I and Yao K. Ann Surg Oncol 2015 22:3767–3768

Conclusions• Literature says: fear,

inadequate education, over-estimation of risk

• Patients say: “rational fear”, practical concerns

• Multiple factors, not as simple as some studies imply

• Extensive discussion, education, identification of bias

• Respect personal choice