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NCCN Clinical Practice Guidelines in Oncology™

Pancreatic

Adenocarcinoma

V.2.2006

www.nccn.org



Pancreatic Adenocarcinoma

Version 2.2006, 07/05/06 © 2006 National Comprehensive Cancer Network, Inc. All rights reserved. These guidelines and this illustration may not be reproduced in any form without the express written permission of NCCN.

NCCN® Practice Guidelines

in Oncology – v.2.2006

Guidelines Index

Pancreatic Table of Contents

Staging, MS, References

NCCN Pancreatic Adenocarcinoma Panel Members

Margaret Tempero, MD/Chair

UCSF Comprehensive Cancer Center

Rameezs Alasadi, MDRobert H. Lurie Comprehensive

Cancer Center of Northwestern

University

Stephen Behrman, MD

St. Jude Children's Research

Hospital/University of Tennessee

Cancer Institute

Edgar Ben-Josef, MDUniversity of Michigan Comprehensive

Cancer Center

Al B. Benson, III, MD

Robert H. Lurie Comprehensive

Cancer Center of Northwestern

University

Pankaj Bhargava, MDDana-Farber/Partners CancerCare

John L. Cameron, MD

The Sidney Kimmel Comprehensive

Cancer Center at Johns Hopkins

†

†

†

†

‡

¤

¶

§

¶

å

Ephraim S. Casper, MD

Memorial Sloan-Kettering Cancer

Center

Stephen Shibata, MD

City of Hope Cancer Center

Dennis C. Shrieve, MD, PhD

Huntsman Cancer Institute at the

University of Utah

Mark Talamonti, MDRobert H. Lurie Comprehensive Cancer

Center of Northwestern University

Douglas S. Tyler, MDDuke Comprehensive Cancer Center

Selwyn M. Vickers, MD

University of Alabama at Birmingham

Comprehensive Cancer Center

Robert S. Warren, MD

UCSF Comprehensive Cancer Center

Christopher Willett, MD

Dana-Farber/Partners CancerCare

Robert A. Wolff, MD

The University of Texas M. D. Anderson

Cancer Center

†

†

§

¶

¶

¶

¶

§

John P. Hoffman, MD

Fox Chase Cancer Center

Wui-Jin Koh, MD

Fred Hutchinson Cancer ResearchCenter/Seattle Cancer Care Alliance

Boris Kuvshinoff, MDRoswell Park Cancer Institute

Mokenge P. Malafa, MDH. Lee Moffitt Cancer Center and Research

Institute at the University of South Florida

Peter Muscarella II, MD

Arthur G. James Cancer Hospital &

Richard J. Solove Research Institute at

The Ohio State University

Aaron R. Sasson, MDUNMC Eppley Cancer Center at The

Nebraska Medical Center

¶

¥

§

¶

¶

¤ ¶

¶

Paula KimTranslating Research Across Communities

(TRAC)

*

* Writing Committee member

*

*

*

*

*

*

*

*

¤ Gastroenterology¶ Surgery/Surgical oncology§ Radiotherapy/Radiation oncology

Medical oncology‡ Hematology/Hematology oncology

Pharmacology ¥ Patient advocacy

†

å

Continue

http://contents.pdf/








Guidelines Index



Table of Contents

NCCN Pancreatic Adenocarcinoma Panel Members

Clinical Presentations and Workup (PANC-1)

No Metastatic Disease (PANC-2)

Resectable or Borderline Resectable, No Jaundice (PANC-3)

Locally Advanced, Unresectable, No Jaundice, No

Metastases (PANC-5)

Resectable or Borderline Resectable, Jaundice, No

Metastases (PANC-6)

Locally Advanced, Unresectable, Jaundice, No Metastases

(PANC-8)Recurrent or Metastatic Disease: Treatment (PANC-9)

Principles of Surgery (PANC-A)

Criteria Defining Resectability Status (PANC-B)

Principles of Radiation Therapy (PANC-C)

Principles of Chemotherapy (PANC-D)

For help using these documents, please click hereStaging

Manuscript

References

Guidelines Index

Print the Pancreatic Adenocarcinoma Guideline

These guidelines are a statement of consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinicianseeking to apply or consult these guidelines is expected to use independent medical judgment in the context of individual clinical circumstances todetermine any patient's care or treatment. The National Comprehensive Cancer Network makes no representations nor warranties of any kindwhatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. These guidelines arecopyrighted by National Comprehensive Cancer Network. All rights reserved. These guidelines and the illustrations herein may not be reproduced inany form without the express written permission of NCCN. ©2006.

Clinical Trials:

Categories of Consensus:NCCN All recommendations are Category2A unless otherwise specified.

See

Thebelieves that the best managementfor any cancer patient is in a clinicaltrial. Participation in clinical trials isespecially encouraged.

NCCN

To find clinical trials online at NCCNmember institutions, click here:nccn.org/clinical_trials/physician.html

NCCN Categories of Consensus

Summary of Guidelines Updates


http://help.pdf/


http://print/

http://www.nccn.org/clinical_trials/physician.html





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http://print/







Guidelines Index



Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.

Metastatic

disease See PANC-9

WORKUPCLINICAL

PRESENTATION

Clinical suspicion of

pancreatic cancer or

evidence of dilatedduct (stricture)

Mass in

pancreas

on imaging

··

Liver function testsChest x-ray

EUS and/or e· ndoscopic

retrograde

cholangiopancreatography

(ERCP) as clinically indicated

·

·

Surgical consultation

Consider endoscopic

ultrasonography (EUS)

Liver function tests·

·Chest x-ray

No

metastatic

disease

Metastatic

disease

No

metastatic

disease

Dynamic-

phase

spiral CT

No mass in

pancreas

on imaging

See PANC-9

See PANC-2

PANC-1

If studies are consistent

with pancreatic cancer,

surgical consultation is

recommendation

Surgical candidateSee PANC-2









Guidelines Index



See WorkupandTreatmentPANC-5( )




Resectable or

borderline resectable

b,c

b,c

Locally advanced

unresectable, no

metastases

Resectable or

borderline resectable

b,c

b,c

Locally advanced

unresectable, no

metastases

No

metastatic

disease

No jaundice

Jaundice

Consider preoperativeCA 19-9 (category 2B)a

Symptoms of

cholangitis or fever present

No symptoms

of cholangitis

and fever

Temporary stent

Consider preoperative

CA 19-9 (category 2B)a

a

c

C if biliary decompression is complete and bilirubin is within normal range .onsider testing for CA 19-9bSee Principles of Surgery (PANC-A

See Criteria Defining Resectability Status (PANC-B

).

).



WORKUPCLINICAL

PRESENTATION

PANC-2









Guidelines Index



Resectable

or borderline

resectable,

no jaundice

b,c

b,c

Candidate for

neoadjuvant

chemo-

radiation

Biopsy,

+ Staging

laparoscopy(category 2B for

borderline resectable)

dEUS directed

biopsy (preferred)

e Yes

No

Biopsy

positive

Biopsy

negative f

Neoadjuvant

chemoradiation

(category 3, for

off clinical trial)



Staging laparoscopy

(category 2B for

borderline resectable)

eLaparotomyResectable

Unresectable

Laparotomy

Laparotomy

Surgicalresection

Unresectable

at surgery

Surgical

resection

Unresectable

at surgery

TREATMENTWORKUPCLINICAL

PRESENTATION

See Adjuvant

Treatment and

SurveillancePANC-4( )

See Adjuvant

Treatment

andSurveillance

PANC-4( )

b

c

d

e

f A negative biopsy should be confirmed by at least one repeat EUS biopsy.

See Principles of Surgery PANC-ASee Criteria Defining Resectability Status PANC-BSee Surgical Principles #1 and #3 (PANC-ASee Surgical Principle #4 PANC-A

( ).( ).

).( ).

PANC-3

Candidate

for surgical

resection

Laparotomy

Surgical

resection

Unresectable

at surgery

See Locally AdvancedUnresectable (PANC-5)

Metastatic Disease (PANC-9)or

See Adjuvant Treatment and

Surveillance (PANC-4)

See LocallyAdvancedUnresectable(PANC-5)

MetastaticDisease(PANC-9)

or

See LocallyAdvancedUnresectable(PANC-5)

Metastatic Disease(PANC-9)

or









Guidelines Index



Surveillance every

3-6 mo for 2 years,then annually:

H&P for

t

CA19-9 level

(category 2B)

·

·

symptom

assessmen

Clinical trial preferredor

Chemoradiation ( - )± additional chemotherapy

(gemcitabine-based)

or

Chemotherapy alone (5-FU or

gemcitabine )

5-FU based h

i

i

ADJUVANT TREATMENT gSURVEILLANCE

g A djuvant treatment should only be considered for patients who have adequately recovered from surgery; treatment should be initiated within 4-8 weeks.h

i

Randomized clinical trial data at this time are inconclusive.

See Principles of Radiation Therapy (PANC-C).



Recurrenceor metastaticdiseaseSee PANC-9( )

PANC-4

Baseline pretreatment

CT scan (category 2B)CA19-9

··

Metastatic diseaseSee PANC-9( )

No evidence of recurrence or metastatic disease









Guidelines Index





WORKUP

Good

performance

status

Poor

performance

status

Adenocarcinoma

confirmed

Other cancer confirmed

Cancer not

confirmed

Repeat biopsy

Consider

laparoscopy,

if not

previously

done

Treat with appropriateNCCN Guideline

Cancer not confirmed Repeat biopsy

Adenocarcinoma confirmed (see above)

Other cancer confirmed Treat with appropriateNCCN Guideline

Gemcitabine (category 1)

or

Best supportive care

j

or

Gemcitabine-based

combination therapy (category 2B) j

Biopsy

done

if

not

previouslyd

Locally

advanced

unresectable,

,

no metastases

no jaundice

d

j

h

iRandomized clinical trial data at this time are inconclusive.

k

l

Patients with a significant response to chemoradiation may be considered for surgical resection, although there is no definitive evidenceat this time to support this intervention.

Laparoscopy as indicated to evaluate distant disease.

See Principles of Surgery #1 and #3 (PANC-A

See Principles of Chemotherapy (PANC-D

).

).


CLINICAL

PRESENTATION

TREATMENT

Clinical trial preferred

or Chemoradiation

± additional chemotherapy

(gemcitabine-based)

or

Gemcitabine (category 2B)

l

i

h,k,l

j

or

Gemcitabine-based combination

therapy (category 2B) j

SALVAGE THERAPY

Clinical trial

or Fluorinated

pyrimidine-based

therapy

(category 2B)

or


j

PANC-5

See NCCN Supportive Care Guidelines

See NCCN Supportive

Care Guidelines





















Guidelines Index





WORKUPCLINICAL

PRESENTATION

TREATMENT

Candidate for

neoadjuvantchemo-

radiation

Biopsy

+ Staging laparoscopy

(category 3 for resectable,

category 2B for borderline

resectable)

d

e

Yes

No

Biopsy

positive

Biopsy

negative

P

followed by

neoadjuvant

chemoradiation

(category 3, for

off clinical trial)

lacement of a

temporary stent

Staging laparoscopy

(category 3 for resectable,

category 2B for borderline

resectable)

e,m

LaparotomyResectable

Unresectable

Laparotomy

Laparotomy

Surgical

resection

Resectable

or borderline

resectable,

jaundice, no

metastases

b,c

b,c

Unresectable,

biliary bypass ±

duodenal bypass

(category 2B for

prophylactic

duodenal bypass)

Unresectable

at surgery

Surgical

resection

SeeTreatmentPANC-7( )

See Adjuvant

Treatment

and

Surveillance

PANC-4( )

SeeTreatmentPANC-7( )

See Adjuvant

Treatment

and

Surveillance

PANC-4( )

b

c

d

e

m

Biliary bypass may be performed at the time of laparoscopy.

See Principles of Surgery (PANC-ASee Criteria Defining Resectability Status (PANC-BSee Surgical Principles #1 and #3 (PANC-ASee Surgical Principle #4 (PANC-A

).).

).).

PANC-6










Guidelines Index





No

metastases

Metastasis

Good

performance

status

Poor

performance

status

Biopsy,

if not

previously

done

d


or


therapy (category 2B)

or

Best Supportive Care

j

j

Unresectable

after

laparoscopy

or

laparotomy,

jaundice

Permanent

stent n

Good

performance

status

Poor

performance

status


or


j

See NCCN Supportive

Care Guidelines

Permanent

stentn

d

j

n

h


Unless biliary bypass performed at time of laparoscopy or laparotomy.

kPatients with a significant response to chemoradiation may beconsidered for surgical resection, although there is no definitiveevidence at this time to support this intervention.

See Surgical Principles #1 and #3 (PANC-A


).

).


CLINICAL

PRESENTATION

TREATMENT


or


or

Gemcitabine-based

combination therapy

j

j

WORKUP

Clinical trial

or

Fluorinatedpyrimidine-based

therapy

(category 2B)

or


j

See NCCN

Supportive Care

Guidelines

SALVAGE THERAPY


or Chemoradiation

± additional chemotherapy

(gemcitabine-based)

or

Gemcitabine (category 2B)

h,k

i

j

or


therapy (category 2B) j

Clinical trial

or Fluorinated

pyrimidine-based

therapy

(category 2B)

or


j

See NCCN Supportive

Care Guidelines

PANC-7


G id li I d























Guidelines Index





Adeno-

carcinoma

confirmed

Other cancer confirmed

Cancer not

confirmed

Repeat

biopsy d


Cancer not confirmed Repeat biopsy

Adenocarcinoma confirmed (see above)

Other cancer confirmedTreat with appropriateNCCN Guideline

Good

performance

status

Poor

performance

status


or


j

See NCCN Supportive Care GuidelinesBiopsy

Locally

advanced,unresectable,

, no

metastases

jaundice

Permanentstent

Nometastases

Temporary

stent

d

h

j


k

l

Patients with a significant response to chemoradiation may be considered for surgicalresection, although there is no definitive evidence at this time to support this intervention.

Laparoscopy as indicated to evaluate distant disease.

See Surgical Principles #1 and #3 PANC-A( ).See Principles of Radiation Therapy (PANC-C


).

).

WORKUPCLINICAL

PRESENTATION

PRIMARY TREATMENT/ADJUVANT TREATMENT


or Chemoradiation

± additional

chemotherapy

(gemcitabine-based)

or

Gemcitabine

(category 2B)

or Gemcitabine-based

combination therapy

(category 2B)

l

i

j

h,k,l

j

Recurrenceor metastaticdisease(See PANC-9)

PANC-8

Guidelines Index



















Guidelines Index



Repeat

biopsy d



Recurrence

or

Metastatic

disease

Biliary

obstruction

No biliary

obstruction

Permanent

stent

Percutaneousbiopsy

(metastatic

site preferred)

Adenocarcinoma

confirmed

Cancer not

confirmed

Other cancer

confirmed


Good

performance

status

Repeat

biopsy

Consider

laparoscopy

d

Clinical trial

or Fluorinated

pyrimidine-based

therapy

(category 2B)

or


j

See NCCN

Supportive CareGuidelines

SALVAGE THERAPY

Poor

performance

status

Cancer not

confirmed

Adenocarcinomaconfirmed (see above)

Other cancer

confirmed

d

jSee Surgical Principle #1 and #3 PANC-A

See Principles of Chemotherapy PANC-D

( ).

( ).

CLINICAL

PRESENTATION


or


j


PANC-9


or

Gemcitabine

(category 1)

or

Gemcitabine-based

combination therapy

j

j

Guidelines Index






















Guidelines Index





PRINCIPLES OF SURGERY

#1 Decisions about diagnostic management and resectability should involve

multidisciplinary consultation with reference to appropriate radiographic studies to

evaluate extent of disease.

#2 Resections should be done at institutions that perform a large number of

pancreatic resections annually.

#3 Endoscopic ultrasound (EUS) may be complimentary to CT. EUS-directed FNA

biopsy may be preferable to a CT-guided FNA in patients with resectable disease

because of the lower risk of peritoneal seeding with EUS FNA when compared with

the percutaneous approach.

#4 Diagnostic staging laparoscopy to rule out subradiologic metastases (especially

for body and tail lesions) is used routinely in some institutions prior to surgery or chemoradiation, or selectively in patients who are at higher risk for disseminated

disease, such as those with borderline resectable disease or poor prognostic factors

(eg, markedly elevated CA19-9 or large, bulky primary tumor).

#5 Further study is necessary to determine whether positive cytology from washings

obtained at laparoscopy is a contraindication to resection or other local treatment.

PANC-A

Guidelines Index











Guidelines Index





CRITERIA DEFINING RESECTABILITY STATUS

RESECTABLE

HEAD/BODY/TAILNo distant metastasesClear fat plane around celiac and superior mesenteric arteries

(SMA)

Patent superior mesenteric vein (SMV)/portal vein

BORDERLINE RESECTABLE

·

>

>

>

1

·

·

HEAD/BODYSevere unilateral SMV/portal impingementTumor abutment on SMAGastroduodenal artery (GDA) encasement up to origin at

hepatic arteryTumors briefly involving the IVCSMV occlusion, if of a short segment, with open vein both

proximally and distally (If the proximal SMV were occluded up

to the portal vein branches then it would be unresectable)Colon or mesocolon invasion

TAILAdrenal, colon or mesocolon, or kidney invasion (category 2B)Preoperative evidence of biopsy-positive peripancreatic lymph

node

>

>

>

>

>

>

>

>

UNRESECTABLE

HEADDistant metastases (includes celiac and/or para-aortic) (category 2B)SMA, celiac encasementSMV/portal occlusion

Aortic, Inferior vena cava (IVC) invasion or encasementInvasion of SMV below transverse mesocolon

BODYDistant metastases (includes celiac and/or para-aortic) (category 2B,

Body and tail lesions that have positive celiac and/or paraaortic

nodes in close vicinity to the primary may also be borderline rather

than unresectable)SMA, celiac, hepatic encasement

SMV/portal occlusionAortic invasion

TAILDistant metastases (includes celiac and/or para-aortic)

a

SMA, celiac encasementRib, vertebral invasion

·

·

·

>

>

>

>

>

>

>

>

>

>

>

>

(category 2B,

Body and tail lesions th t have positive celiac and/or paraaortic

nodes in close vicinity to the primary may also be borderline rather

than unresectable)

PANC-B

1

For any of these tumors where an incomplete (R1 or R2) resection is anticipated, it is suggested that chemoradiation be given prior to surgery.

Guidelines Index











Guidelines Index





PRINCIPLES OF RADIATION THERAPY

ADJUVANT RTIn contrast to the GITSG trial more recent phase III trials have not provided evidence of benefit from

radiotherapy in this setting. The most recent trial, ESPAC-1 has even suggested that radiotherapy is detrimental.

However, these trials have been criticized widely for lack of statistical power (EORTC) and serious flaws in

conduct and reporting (ESPAC). Therefore, these latest results cannot support a change in the standard of care,

and 5-FU based radiochemotherapy in the adjuvant setting is an acceptable choice.Use of CT simulation and 3D treatment planning is strongly encouraged.Treatment volumes should be based on preoperative CT scans and surgical clips (when placed)

Treatment volumes include the location of the primary tumor and regional lymph nodesDose: 45-54 Gy (1.8-2.0 Gy/day)

DEFINITIVE RTRadiation is usually given in combination with 5-FU chemotherapy. Recent evidence suggests that concurrent

gemcitabine and radiation can yield similar outcomes.Use of CT simulation and 3D treatment planning is strongly encouragedTreatment volumes should be based on CT scans and surgical clips (when placed)When 5-FU based radiochemotherapy is employed, treatment volumes include the location of the primary

tumor and regional lymph nodesThe dose for definitive 5-FU based radiochemotherapy is 50-60 Gy (1.8-2.0 Gy/day)

,1

2

3

>

>

>

>

>

>

>

>

PANC-C

1

2

3

GITSG trial: Moertel CG, Frytak S, Hahn RG, et al. Therapy of locally unresectable pancreatic carcinoma: A randomized comparison of high dose (6000 rads)radiation alone, moderate dose radiation (4000 rads + 5-fluorouracil), and high dose radiation + 5-fluorouracil. Cancer 1981;48:1705-1710.

ESPAC-1 trial: Neoptolemos JP, Stocken DD, Friess H, et al. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer.N Engl J Med 2004;350:1200-1210.

EORTC trial: Klinkenbijl JH, Jeekel J, Sahmoud T, et al. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas andperiampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg 1999;230:776-782; discussion 782-784.






NCCN®

Guidelines Index








in Oncology – v.2.2006Pancreatic Table of Contents


Table 1

American Joint Committee on Cancer (AJCC)TNM Staging of Pancreatic Cancer (2002)

Primary Tumor (T)

Distant Metastasis (M)

Because only a few patients with pancreatic cancer undergo

surgical resection of the pancreas (and adjacent lymph nodes), a

single TNM classification must apply to both clinical and pathologic

staging.

Primary tumor cannot be assessed

No evidence of primary tumor

Carcinoma

Tumor limited to the pancreas, 2 cm or less in greatest

dimensionTumor limited to the pancreas, more than 2 cm in greatest

dimension

Tumor extends beyond the pancreas but without involvement of

the celiac axis or the superior mesenteric artery

Tumor involves the celiac axis or the superior mesenteric

artery (unresectable primary tumor)

*This also includes the “PanInIII” classification.

Regional lymph nodes cannot be assessed

No regional lymph node metastasis

Regional lymph node metastasis

Distant metastasis cannot be assessed

No distant metastasis

Distant metastasis

Tis N0 M0

T1 N0 M0

T2 N0 M0

T3 N0 M0

T1 N1 M0

T2 N1 M0

T3 N1 M0

T4 Any N M0

Any T Any N M1

TX

T0

Tis

T1

T2

T3

T4

Regional Lymph Nodes (N)

NX

N0

N1

MX

M0

M1

Stage 0

Stage IA

Stage lB

Stage IIA

Stage IIB

Stage Ill

Stage IV

in situ*

Used with the permission of the American Joint Committee on Cancer

(AJCC), Chicago, Illinois. The original and primary source for thisinformation is the AJCC Cancer Staging Manual, Sixth Edition (2002)

published by Springer-Verlag New York. (For more information, visit

.) Any citation or quotation of this material must be

credited to the AJCC as its primary source. The inclusion of this information

herein does not authorize any reuse or further distribution without the

expressed, written permission of Springer-Verlag New York, Inc., on behalf

of the AJCC.

Stage Grouping

www.cancerstaging.net

STAGING CONTINUED ON ST-2

Staging

ST-1

NCCN® P ti G id li

Guidelines Index

P ti T bl f C t t

http://www.cancerstaging.net/










in Oncology – v.2.2006Pancreatic Table of Contents


Table 1 continued

Histopathologic Type

Histologic Grade (G)

The staging system applies to all exocrine carcinomas that arise in

the pancreas. It does not apply to endocrine tumors, which usually

arise from the islets of Langerhans. Carcinoid tumors are also

excluded. More than 90% of malignant tumors of the pancreas are

exocrine carcinomas. The following carcinomas are included:

Grade cannot be assessed

Well differentiated

Moderately differentiated

Poorly differentiated

Undifferentiated

·

·

·

·

·

·

·

·

·

·

·

·

·

·

·

··

·

Severe ductal dysplasia/carcinoma in situ (PanIn III; pancreatic

intraepithelial neoplasia)

Ductal adenocarcinoma

Mucinous noncystic carcinoma

Signet ring cell carcinoma

Aden osquamous carcinoma

Undifferentiated carcinoma (Spindle and giant cell types; Small cell

types)

Mixed ductal-endocrine carcinoma

Osteoclast-like giant cell tumor

Serous cystadenocarcinoma

Mucinous cystadenocarcinoma

Intraductal papillary mucinous carcinoma with or without invasion

(IPMN)

Acinar cell carcinoma

Acinar cell cystadenocarcinoma

Mixed acinar-endocrine carcinoma

Pancreaticoblastoma

Solid pseudopapillary carcinomaBorderline (uncertain malignant potential) tumors (Mucinous cystic

tumor with moderate dysplasia; Intraductal papillary-mucinous

tumor with moderate dysplasia; Solid pseudopapillary tumor)

Other

GX

G1

G2

G3

G4

ST-2




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