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NCCN Pancreatic Cancer Guidelines
- 2. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
NCCN Pancreatic Adenocarcinoma Panel Members
* Margaret Tempero, MD/Chair †‡ Steven J. Cohen, MD † Aaron R. Sasson, MD ¶
UCSF Comprehensive Cancer Center Fox Chase Cancer Center UNMC Eppley Cancer Center at The
Nebraska Medical Center
J. Pablo Arnoletti, MD ¶ Michelle Duff, PhD ¥
University of Alabama at Birmingham Pancreatic Cancer Action Network (PanCAN) Mark Talamonti, MD ¶
Comprehensive Cancer Center Robert H. Lurie Comprehensive Cancer
Joshua D.I. Ellenhorn, MD ¶ Center of Northwestern University
Stephen Behrman, MD ¶ City of Hope
St. Jude Children's Research Hospital/ Sarah P. Thayer, MD, PhD ¤
University of Tennessee Cancer Institute William G. Hawkins, MD ¶ Dana-Farber/Brigham and Women’s Cancer
Siteman Cancer Center at Barnes-Jewish Hospital Center Massachusetts General Hospital
Edgar Ben-Josef, MD § and Washington University School of Medicine Cancer Center
University of Michigan Comprehensive
Cancer Center Lisa Hazard, MD § Douglas S. Tyler, MD ¶
Huntsman Cancer Institute at the University of Duke Comprehensive Cancer Center
Al B. Benson, III, MD † Utah
Robert H. Lurie Comprehensive Cancer Center Robert S. Warren, MD ¶
of Northwestern University John P. Hoffman, MD ¶ UCSF Comprehensive Cancer Center
Fox Chase Cancer Center
Jordan D. Berlin, MD † Samuel Whiting, MD, PhD
Vanderbilt-INgram Cancer Center Boris Kuvshinoff, MD ¶ Fred Hutchinson Cancer Research
Roswell Park Cancer Institute Center/Seattle Cancer Care Alliance
Pankaj Bhargava, MD †å
Dana-Farber/Brigham and Women’s Cancer Mokenge P. Malafa, MD ¶ Christopher Willett, MD §
Center | Massachusetts General Hospital H. Lee Moffitt Cancer Center and Research Dana-Farber/Brigham and Women’s Cancer
Cancer Center Institute at the University of South Florida Center Massachusetts General Hospital
Cancer Center
John L. Cameron, MD ¶ Peter Muscarella II, MD ¤ ¶
The Sidney Kimmel Comprehensive Cancer Arthur G. James Cancer Hospital & Richard J. Robert A. Wolff, MD †
Center at Johns Hopkins Solove Research Institute at The Ohio State The University of Texas M. D. Anderson
University Cancer Center
Ephraim S. Casper, MD † ¤ Gastroenterology
Memorial Sloan-Kettering Cancer Center Eric K. Nakakura, MD ¶
UCSF Comprehensive Cancer Center ¶ Surgery/Surgical oncology
§ Radiotherapy/Radiation oncology
† Medical oncology
‡ Hematology/Hematology oncology
Continue å Pharmacology
NCCN Guidelines Panel Disclosures
¹ Pathology
¥ Patient advocacy
* Writing Committee member
Version 1.2009, 03/26/09 © 2009 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.
- 3. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
Table of Contents
NCCN Pancreatic Adenocarcinoma Panel Members
Summary of Guidelines Updates For help using these
documents, please click here
Clinical Presentations and Workup (PANC-1)
No Metastatic Disease (PANC-2) This discussion is being
updated to correspond
Resectable, No Jaundice (PANC-3) Discussion
with the newly updated
Borderline Resectable, No Jaundice (PANC-4) References algorithm.
Locally Advanced, Unresectable, No Jaundice, No Metastases (PANC-7)
Clinical Trials: The NCCN
Resectable, Jaundice, No Metastases (PANC-8) believes that the best management
Borderline Resectable, Jaundice, No Metastases (PANC-9) for any cancer patient is in a clinical
trial. Participation in clinical trials is
Locally Advanced, Unresectable, Jaundice (PANC-11) especially encouraged.
Unresectable, Jaundice, Adenocarcinoma Confirmed (PANC-12) To find clinical trials online at NCCN
member institutions, click here:
Recurrence After Resection:Treatment (PANC-13) nccn.org/clinical_trials/physician.html
Principles of Diagnosis and Staging (PANC-A) NCCN Categories of Evidence and
Consensus: All recommendations
Criteria Defining Resectability Status (PANC-B) are Category 2A unless otherwise
Principles of Radiation Therapy (PANC-C) specified.
See NCCN Categories of Evidence
Principles of Chemotherapy (PANC-D) and Consensus
Principles of Palliation and Supportive Care (PANC-E)
Guidelines Index
Print the Pancreatic Adenocarcinoma Guideline
These guidelines are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment.
Any clinician seeking to apply or consult these guidelines is expected to use independent medical judgment in the context of individual clinical
circumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network makes no representations nor warranties
of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. These
guidelines are copyrighted by National Comprehensive Cancer Network. All rights reserved. These guidelines and the illustrations herein may not
be reproduced in any form without the express written permission of NCCN. ©2009.
Version 1.2009, 03/26/09 © 2009 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.
- 4. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
Summary of changes in the 1.2009 version of the Pancreatic Adenocarcinoma guidelines from the 1.2008 version include:
PANC-1 PANC-10
· Added “pancreatic and/or bile” under clinical presentation. It now reads, · Unresectable treatment: unresectable was replaced with stenting
“Clinical suspicion of pancreatic cancer or evidence of dilated pancreatic · Laparotomy changed to read “Repeat abdominal and chest imaging,
and/or bile duct (stricture). laparoscopy (category 2B).”
· “Dynamic phase spiral CT” was changed to “Pancreatic protocol CT.” PANC-12
PANC-2 · “Chemoradiation ± additional chemotherapy (gemcitabine based) ” was
· Under Clinical Presentation, “on physical exam or by imaging” was added revised to read, “Systemic chemotherapy (gemcitabine-based) ±
to “No metastatic disease.” chemoradiation.”
· Footnote “b” was added to preoperative CA 19-9. · ± oxaliplatin was added after fluorinated pyrimidine-based therapy.
· “and antibiotic coverage” was added to temporary stent. · Second-line therapy changed from a category 2B recommendation to a
· Footnote “a” was modified to say, “CA 19-9 may be negative in cases of category 2A recommendation.
benign biliary obstruction or undetectable in Lewis-a negative individuals.” PANC-13
PANC-3 · Changed page to Recurrence after resection.
· New node added to resectable, no jaundice algorithm stating, “Consider · Footnote “u” is new to the page. “Systemic chemotherapy preferred in the
staging laparoscopy in high risk patients or as clinically indicated”. absence of uncontrolled pain.”
PANC-5 PANC-A
· In the borderline resectable, no jaundice algorithm, a new node was added · New principle #2 “Imaging should include pancreatic CT scan. CT should
between neoadjuvant therapy and laparotomy stating, “Repeat abdominal be performed according to a defined pancreas protocol such as triphasic
and chest imaging, laparoscopy (category 2B).” cross sectional imaging and thin slices.”
· Footnote “h” was modified to read “A negative biopsy should be repeated · New principle #3 “PET scan may be considered useful if CT result are
by EUS at least once more.” equivocal.”
PANC-6 PANC-B
· Under adjuvant treatment, chemoradiation (5-FU-based) ± systemic · Updated criteria defining resectability status.
gemcitabine was revised to read, “Systemic gemcitabine followed by PANC-C
chemoradiation (5-FU-based).” · Added the following statement to the top of the page “Incresingly, IMRT is
· Footnote “i” was added to chemoradiation (5-FU-based). being applied for therapy of pancreatic adenocarcinoma. There is no clear
consensus on appropriate maximum dose of radiation in either the adjuvant
PANC-7
setting or in the setting of locally advanced disease.”
· “Chemoradiation ± additional chemotherapy (gemcitabine based) ” was
PANC-D
revised to read, “Systemic chemotherapy (gemcitabine-based) ± · New added 2 principles of chemotherapy: “The CONKO 001 trial
chemoradiation.” demonstrated significant improvements in disease-free survival and overall
· ± oxaliplatin was added after fluorinated pyrimidine-based therapy. survival with use of post-operative gemcitabine as adjuvant chemotherapy
· Second-line therapy changed from a category 2B recommendation to a versus observation in resectable pancreatic adenocarcinoma.”
category 2A recommendation. · “No significant differences were observed in the RTOG 97-04 study
· Footnote “l” was revised, “Chemoradiation should be reserved for patients comparing pre- and post- chemoradiation 5-FU with pre- and post-
who do not develop metastatic disease while receiving systemic chemoradiation gemcitabine for post-operative adjuvant treatment.
chemotherapy” was added. However, overall survival was significantly increased in the gemcitabine
PANC-8
arm compared with the 5-FU arm in the subset of patients with tumors of
· New node added to resectable, no jaundice algorithm stating, “Consider
the pancreatic head.”
staging laparoscopy in high risk patients or as clinically indicated”.
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.
Version 1.2009, 03/26/09 © 2009 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. UPDATES
- 5. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
CLINICAL WORKUP
PRESENTATION
· Surgical consultation
No · Consider endoscopic
metastatic Surgical candidate
ultrasonography (EUS)
See PANC-2
disease · Liver function tests
· Chest imaging
Mass in
pancreas
on imaging
Metastatic
disease See PANC-12
Clinical suspicion
of pancreatic
Pancreatic
cancer or evidence
protocol CT
of dilated
(See PANC-A) · Liver function tests If studies are
pancreatic and/or · Chest imaging consistent with
bile duct (stricture) No · EUS and/or
metastatic pancreatic cancer,
endoscopic retrograde surgical consultation
disease cholangiopancreatography is recommended
(ERCP) as clinically indicated See PANC-2
No mass in
pancreas
on imaging
Metastatic
disease See PANC-12
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-1
- 6. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
CLINICAL WORKUP
PRESENTATION
See Workup
Resectable b,c and Treatment
(PANC-3)
See Workup
No jaundice Preoperative CA 19-9 a,b Borderline resectable b,c (PANC-4) and
Treatment
(PANC-5)
No metastatic Locally advanced See Workup
disease on unresectable, no and Treatment
physical exam metastases (PANC-7)
and by imaging Symptoms of
cholangitis or Temporary stent and
fever present antibiotic coverage See Workup
Resectable b,c and Treatment
Jaundice (PANC-8)
No symptoms See Workup
Preoperative CA 19-9 a,b (PANC-9) and
of cholangitis Borderline resectable b,c
Treatment
and fever (PANC-10)
Locally advanced See Workup
unresectable, no and Treatment
metastases (PANC-10)
a CA 19-9 may be negative in cases of benign biliary obstruction or undetectable in Lewis-a negative individuals.
b See Principles of Diagnosis and Staging (PANC-A).
c See Criteria Defining Resectability Status (PANC-B).
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-2
- 7. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
CLINICAL WORKUP TREATMENT
PRESENTATION
Surgical See Adjuvant Treatment and
resection Surveillance (PANC-6)
Consider staging
Resectable, c,d laparoscopy b in high
Laparotomy See Locally Advanced
no jaundice risk patients or as
Unresectable (PANC-7)
clinically indicated
Unresectable
at surgery
Metastatic Disease (PANC-13)
b See Principles of Diagnosis and Staging (PANC-A).
cSee Criteria Defining Resectability Status (PANC-B).
d Consider neoadjuvant therapy on clinical trial.
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-3
- 8. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
CLINICAL PRESENTATION WORKUP
Candidate for
neoadjuvant therapy
Planned
neoadjuvant
therapy e Resectable
(category 2B) Biopsy, EUS directed biopsy
Borderline (preferred) f if neoadjuvant
resectable, b,c See Treatment
OR therapy is planned + staging (PANC-5)
no jaundice
laparoscopy g (category 2B)
Planned
resection Locally advanced
(category 2B)
Metastatic disease
b See Principles of Diagnosis and Staging (PANC-A).
c See Criteria Defining Resectability Status (PANC-B).
e The majority of NCCN institutions prefer neoadjuvant therapy in the setting of borderline resectable disease.
f See Principles of Diagnosis and Staging #1 and #5 (PANC-A).
g See Principles of Diagnosis and Staging 6 (PANC-A).
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-4
- 9. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
TREATMENT
See Adjuvant Treatment
Surgical resection
and Surveillance (PANC-6)
Biopsy Neoadjuvant therapy Repeat:
positive (category 2B) · Abdominal and
Candidate for
chest imaging
neoadjuvant
· Laparoscopy
therapy Biopsy (category 2B)
negative h
Unresectable at surgery See Locally Advanced
Unresectable (PANC-7)
See Adjuvant Treatment
Surgical resection
and Surveillance (PANC-6)
Resectable Laparotomy
Unresectable at surgery
See Locally Advanced
Unresectable (PANC-7)
Locally advanced
Metastatic disease Metastatic Disease
(PANC-12)
h A negative biopsy should be repeated by EUS at least once more.
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-5
- 10. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
POST-OPERATIVE ADJUVANT TREATMENT i SURVEILLANCE
Clinical trial preferred
or
Surveillance every 3-6 mo
Systemic gemcitabine followed
for 2 years, then annually:
by chemoradiation (5-FU-based) i,j
No evidence or · H&P for symptom
assessment Recurrence
of recurrence Chemotherapy alone: after resection
or metastatic · Gemcitabine preferred · CA19-9 level
(See PANC-13)
disease (category 2B)
or
· 5-FU · CT scan
or (category 2B)
· Capecitabine
Baseline pretreatment
· CT scan
· CA19-9
Metastatic disease
(See PANC-12)
i A djuvant treatment should be administered to patients who have not had neoadjuvant therapy and who have adequately recovered from surgery; treatment should be
initiated within 4-8 weeks. If systemic chemotherapy precedes chemoradiation, restaging with a CT scan should be done after each treatment modality. Patients who
have received neoadjuvant chemoradiation or chemotherapy are candidates for further adjuvant therapy following surgery.
j See Principles of Radiation Therapy (PANC-C).
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-6
- 11. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
CLINICAL WORKUP TREATMENT SALVAGE THERAPY
PRESENTATION
Clinical trial (preferred)
Clinical trial preferred Good or
or performance Fluorinated pyrimidine-
Systemic chemotherapy status based therapy ±
Good (gemcitabine-based) m oxaliplatin n,p
performance ± chemoradiation j,k,l
status or
Gemcitabine n
or Poor
Adenocarcinoma
Gemcitabine-based performance Best supportive care o
confirmed
combination therapy n status
Poor Gemcitabine n (category 1)
performance or
status Best supportive care o
Locally
advanced Biopsy if not Repeat biopsy
unresectable, previously Adenocarcinoma confirmed (see above)
Consider
no jaundice, done f Cancer not laparoscopy
no metastases Cancer not confirmed Repeat biopsy
confirmed with biopsy, if
not previously
Other cancer confirmed Treat with appropriate
done NCCN Guideline
Other cancer confirmed Treat with appropriate NCCN Guideline
f See Principles of Diagnosis and Staging #1 and #5 (PANC-A).
j See Principles of Radiation Therapy (PANC-C).
k Laparoscopy as indicated to evaluate distant disease. m Randomized clinical trial data at this time are inconclusive.
l Chemoradiation should be reserved for patients who do not develop n See Principles of Chemotherapy (PANC-D).
metastatic
disease while receiving systemic chemotherapy. Patients with a significant o See Principles of Palliation and Supportive Care (PANC-E).
response to chemoradiation may be considered for surgical resection, although p For fluorinated pyrimidine naive patients. Gemcitabine is also an option for patients
there is no definitive evidence at this time to support this intervention. who received 5-FU chemoradiation and no additional chemotherapy.
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-7
- 12. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
CLINICAL WORKUP TREATMENT
PRESENTATION
Surgical resection See Adjuvant Treatment and
Surveillance (PANC-6)
Consider staging
Resectable, b,c,d
laparoscopy g in high risk
jaundice, no Laparotomy
patients or as clinically
metastases
indicated
See Locally Advanced
Unresectable at surgery Unresectable (PANC-11)
or
Metastatic Disease (PANC-12)
b See Principles of Diagnosis and Staging (PANC-A).
c See Criteria Defining Resectability Status (PANC-B).
d Consider neoadjuvant therapy on clinical trial.
g See Principles of Diagnosis and Staging #6 (PANC-A).
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-8
- 13. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
CLINICAL PRESENTATION WORKUP
Candidate for
neoadjuvant therapy
Planned neoadjuvant Resectable
Biopsy, EUS directed
Borderline therapy e (category 2B)
biopsy (preferred) f if
resectable, b,c See Treatment
jaundice, no OR neoadjuvant therapy is
(PANC-10)
metastases planned + staging
Planned resection e laparoscopy g (category 2B)
(category 2B) Locally advanced
Metastatic disease
b See Principles of Diagnosis and Staging (PANC-A).
c See Criteria Defining Resectability Status (PANC-B).
d Consider neoadjuvant therapy on clinical trial.
e The majority of NCCN institutions prefer neoadjuvant therapy in the setting of borderline resectable disease.
f See Principles of Diagnosis and Staging #1 and #5 (PANC-A).
g See Principles of Diagnosis and Staging #3 and 6 (PANC-A).
qBiliary bypass may be performed at the time of laparoscopy.
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-9
- 14. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
TREATMENT
Placement of a
temporary
Surgical See Adjuvant Treatment
Biopsy stent followed Repeat:
resection and Surveillance (PANC-6)
Candidate for
positive by neoadjuvant · Abdominal
therapy and chest Stenting or biliary
neoadjuvant
(category 2B) imaging bypass See Locally
therapy
Biopsy · Laparoscopy ± duodenal bypass Advanced
negative h (category 2B) Unresectable
Unresectable (category 2B for
(PANC-11)
at surgery prophylactic
duodenal bypass)
± open ethanol Metastatic
celiac plexus block Disease
(category 2B) (PANC-12)
Surgical See Adjuvant Treatment
resection and Surveillance (PANC-6)
Resectable Laparotomy
Stenting or biliary
See Locally
Unresectable bypass
Advanced
at surgery ± duodenal bypass Unresectable
(category 2B for (PANC-11)
prophylactic
duodenal bypass)
Locally advanced Metastatic
± open ethanol Disease
celiac plexus block (PANC-12)
(category 2B)
Metastatic disease Metastatic Disease (PANC-12)
h A negative biopsy should be repeated by EUS at least once more.
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-10
- 15. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
CLINICAL WORKUP PRIMARY TREATMENT/ADJUVANT TREATMENT
PRESENTATION
Adenocarcinoma confirmed See PANC-12
Adenocarcinoma confirmed See PANC-12
Locally
advanced, Cancer not Temporary Repeat
Biopsy f Cancer not confirmed Repeat biopsy r
unresectable, confirmed stent biopsy f
jaundice
Other cancer confirmed Treat with appropriate
NCCN Guideline
Other cancer confirmed Treat with appropriate NCCN Guideline
f See Principles of Diagnosis and Staging #1 and #5 (PANC-A).
r In this situation a laparscopic-directed biopsy may be useful.
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-11
- 16. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
CLINICAL WORKUP TREATMENT SALVAGE THERAPY
PRESENTATION
Clinical trial preferred Clinical trial
or or
Good
Gemcitabine n (category 1) Fluorinated pyrimidine-based
performance
or therapy n,p ± oxaliplatin
status
Gemcitabine-based or
Permanent combination therapy n Best supportive careo
Metastasis stent if
jaundice t
Poor Gemcitabine n (category 1)
performance or
status Best supportive care o
Unresectable,
Clinical trial preferred
Adenocarcinoma
or
confirmed Clinical trial
Chemotherapy
or Recurrence
(gemcitabine based)m
Good Fluorinated pyrimidine- or metastatic
± chemoradiationj,k,l
performance based therapy n,p disease
or
status ± oxaliplatin See above
Gemcitabine n pathway
or
or
No Best supportive careo
Permanent Gemcitabine-based
metastases,
metal stent t combination therapy n
jaundice
Poor Gemcitabine n (category 1)
performance or
status Best supportive care o
j See n See Principles of Chemotherapy (PANC-D).
Principles of Radiation Therapy (PANC-C).
l Patients with a significant response to chemoradiation may be considered for o See Principles of Palliation and Supportive Care (PANC-E).
surgical resection, although there is no definitive evidence at this time to support p For fluorinated pyrimidine naive patients. Gemcitabine is also an option for
this intervention. patients who received 5-FU chemoradiation and no additional chemotherapy.
m Randomized clinical trial data at this time are inconclusive. t Unless biliary bypass performed at time of laparoscopy or laparotomy.
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-12
- 17. Guidelines Index
NCCN
®
Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
CLINICAL PRESENTATION TREATMENT SALVAGE THERAPY
Clinical trial (preferred)
or
Local
Consider chemoradiation j if not previously done
recurrence or
Best supportive care
Consider
Recurrence
biopsy for
after
confirmation Clinical trial (preferred)
resection
(category 2B) or
Greater than 6 mo
Systemic therapy as
from completion
previously administered n
of primary therapy or
Consider Best supportive care o
Metastatic chemoradiation j in
disease with or the setting of
without local uncontrolled pain due
recurrence to local recurrence if
not previously given u Clinical trial (preferred
or
Less than 6 mo
Switch to alternative systemic
from completion
chemotherapy n
of primary therapy
or
Best supportive care o
jSee Principles of Radiation Therapy (PANC-C).
n See Principles of Chemotherapy (PANC-D).
o See Principles of Palliation and Supportive Care (PANC-E).
u Systemic chemotherapy preferred in the absence of uncontrolled pain.
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.
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- 18. Guidelines Index
NCCN
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Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
PRINCIPLES OF DIAGNOSIS AND STAGING
#1 Decisions about diagnostic management and resectability should involve multidisciplinary consultation with reference to
appropriate radiographic studies to evaluate the extent of disease. Resections should be done at institutions that perform a large
number (15-20) of pancreatic resections annually.
#2 Imaging should include pancreatic CT scan. CT should be performed according to a defined pancreas protocol such as triphasic
cross-sectional imaging and thin slices.
#3 PET scan may be considered useful if CT results are equivocal.
#4 Endoscopic ultrasound (EUS) may be complementary to CT for staging.
#5 EUS-directed FNA biopsy is preferable to a CT-guided FNA in patients with resectable disease because of the much lower risk of
peritoneal seeding with EUS FNA when compared with the percutaneous approach. Biopsy proof of malignancy is not required before
surgical resection and a nondiagnostic biopsy should not delay surgical resection when the clinical suspicion for pancreatic cancer is
high.
#6 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 (borderline
resectable disease, markedly elevated CA19-9 or large primary tumors).
#7 Positive cytology from washings obtained at laparoscopy or laparotomy is equivalent to M1 disease. If resection has been done for
such a patient, they should be treated as for M1 disease.
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.
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- 19. Guidelines Index
NCCN
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Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
CRITERIA DEFINING RESECTABILITY STATUS
RESECTABLE UNRESECTABLE
· HEAD/BODY/TAIL · HEAD
> No distant metastases > Distant metastases
> Clear fat plane around celiac and superior mesenteric arteries > Greater than 180 degrees SMA encasement, any celiac abutment
(SMA) > Unreconstructible SMV/portal occlusion
> Patent superior mesenteric vein (SMV)/portal vein > Aortic invasion or encasement
· BODY
BORDERLINE RESECTABLE 1 > Distant metastases
· HEAD/BODY > SMA or celiac encasement greater than 180 degrees
> Severe unilateral or bilateral SMV/portal impingement > Unreconstructible SMV/portal occlusion
> Less than 180 degree tumor abutment on SMA > Aortic invasion
> Abutment or encasement of hepatic artery, if reconstructible. · TAIL
> SMV occlusion, if of a short segment, and reconstructible. > Distant metastases
· TAIL > SMA or celiac encasement greater than 180 degrees
> SMA or celiac encasement less than 180 degree · Nodal status
> Metastases to lymph nodes beyond the field of resection should
be considered unresectable.
1 For any tumors where there is a higher likelihood of an incomplete (R1 or R2) resection, it is suggested that chemoradiation be given prior to surgery.
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.
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- 20. Guidelines Index
NCCN
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Practice Guidelines Pancreatic Table of Contents
in Oncology – v.1.2009 Pancreatic Adenocarcinoma Staging, Discussion, References
PRINCIPLES OF RADIATION THERAPY
Increasingly, IMRT is being applied for therapy of pancreatic adenocarcinoma. There is no clear consensus on
appropriate maximum dose of radiation in either the adjuvant setting or in the setting of locally advanced disease.
NEOADJUVANT/ADJUVANT RT
In contrast to the GITSG trial, 1,2 more recent phase III trials have not provided evidence of benefit from radiotherapy in
this setting. A recent trial, ESPAC-1 has even suggested that radiotherapy is detrimental. 3 However, these trials have
been criticized widely for lack of statistical power (EORTC) 4 and inadequate quality control (ESPAC). Therefore, 5-FU
based chemoradiotherapy as part of adjuvant therapy remains 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 nodes
> Dose: 45-54 Gy (1.8-2.0 Gy/day)
DEFINITIVE RT FOR UNRESECTABLE TUMORS
Radiation 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 encouraged
> Treatment 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 nodes.
> The dose for definitive 5-FU based radiochemotherapy is 50-60 Gy (1.8-2.0 Gy/day)
1 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.
2 Kalser, Mlt, Ellenberg SS. Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch. Surg. 1985;20:899-903.
3 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.
4 EORTC trial: Klinkenbijl JH, Jeekel J, Sahmoud T, et al. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and
periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg 1999;230:776-782; discussion 782-784.
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.
Version 1.2009, 03/26/09 © 2009 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. PANC-C