NCCN Clinical Practice Guidelines in Oncology™



  Pancreatic
Adenocarcinoma
                   V.1.2009




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Pancreatic

  1. 1. NCCN Clinical Practice Guidelines in Oncology™ Pancreatic Adenocarcinoma V.1.2009 Continue www.nccn.org
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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-13
  18. 18. Guidelines Index NCCN ® 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. 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-A
  19. 19. Guidelines Index NCCN ® 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. 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-B
  20. 20. Guidelines Index NCCN ® 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
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