2007直肠癌指南

Continue NCCN Clinical Practice Guidelines in Oncology™ Rectal Cancer V.1.2007 www.nccn.org Continue Rectal Cancer Version 1.2007, 01/02/07 © 2007 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.1.2007 Guidelines Index Rectal Cancer Table of Contents Staging, MS, References NCCN Rectal Cancer Panel Members Continue * Edward W. Martin, Jr., MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute at The Ohio State University Sujata Rao, MD Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Leonard Saltz, MD Þ Memorial Sloan-Kettering Cancer Center David Shibata, MD H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida The University of Texas M. D. Anderson Cancer Center UCSF Comprehensive Cancer Center ¶ † † ‡ ¶ John M. Skibber, MD ¶ Alan P. Venook, MD † ‡ Dayna S. Early, MD ¤ Siteman Cancer Center at Barnes- Jewish Hospital and Washington University School of Medicine Marwan G. Fakih, MD Roswell Park Cancer Institute Charles Fuchs, MD Dana-Farber/Partners CancerCare Jean L. Grem, MD UNMC Eppley Cancer Center at The Nebraska Medical Center Krystyna Kiel, MD § Robert H. Lurie Comprehensive Cancer Center of Northwestern University James A. Knol, MD University of Michigan Comprehensive Cancer Center Lucille A. Leong, MD City of Hope Cancer Center Kirk A. Ludwig, MD Duke Comprehensive Cancer Center † † † ¶ † ¶ Paul F. Engstrom, MD/Chair Fox Chase Cancer Center § Comprehensive Cancer Center at † ¶ † ¶ ¶ Juan Pablo Arnoletti, MD University of Alabama at Birmingham Comprehensive Cancer Center Al B. Benson, III, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University Yi-Jen Chen, MD, PhD City of Hope Cancer Center Michael A. Choti, MD The Sidney Kimmel Johns Hopkins Harry S. Cooper, MD Fox Chase Cancer Center Raza A. Dilawari, MD St. Jude Children's Research Hospital/University of Tennessee Cancer Institute � † Medical Oncology ¶ Surgery/Surgical oncology Pathology ‡ Hematology/Hematology Oncology Þ Internal medicine § Radiotherapy/Radiation oncology *Writing Committee Member � ¤ Gastroenterology * Rectal Cancer Version 1.2007, 01/02/07 © 2007 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.1.2007 Guidelines Index Rectal Cancer Table of Contents Staging, MS, References This manuscript is being updated to correspond with the newly updated algorithm. Table of Contents Clinical Presentations and Primary Treatment: NCCN Rectal Cancer Panel Members Surveillance (REC-7) Recurrence and Workup (REC-8) Postoperative CEA Elevation (REC-8) Principles of Pathologic Review (REC-A) Principles of Surgery (REC-B) Principles of Adjuvant Therapy (REC-C) Principles of Radiation Therapy (REC-D) Chemotherapy for Advanced or Metastatic Disease (REC-E) � � � Pedunculated polyp with invasive cancer (REC-1) Sessile polyp with invasive cancer (REC-1) Rectal cancer appropriate for resection (REC-2) T1-2, N0: Primary and Adjuvant Treatment (REC-3) T3, N0 or T any, N1-2: Primary and Adjuvant Treatment (REC-4) T4 and/or locally unresectable: Primary and Adjuvant Treatment (REC-4) T any, N any, M1: Resectable Metastases Treatment and Surveillance (REC-5) � � � � �T any, N any, M1: Unresectable Metastases or Medically Inoperable Treatment (REC-6) These guidelines are a statement of 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. ©2007. Clinical Trials: Categories of Consensus:NCCN The believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. To find clinical trials online at NCCN member institutions, All recommendations are Category 2A unless otherwise specified. See NCCN click here: nccn.org/clinical_trials/physician.html NCCN Categories of Consensus Guidelines Index Print the Rectal Cancer Guideline Order the Patient Version of the Rectal Cancer Guideline Summary of Guidelines Updates For help using these documents, please click here Staging Manuscript References Rectal Cancer Version 1.2007, 01/02/07 © 2007 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.1.2007 Guidelines Index Rectal Cancer Table of Contents Staging, MS, References Summary of the Guidelines updates UPDATES Summary of changes in the 1.2007 version of the Rectal Cancer Guidelines from the 2.2006 version include: � � � � � � � � � � � � � � � � is a new page to the guidelines discussing the management of malignant polyps. Chest CT replaced chest x-ray in the Workup section and proctoscopy was added ( ). Footnote "l" and "m" are new to page . Footnote "q" is new to page . Footnote "p" was modified to include patients greater than or equal to the age of 65 have an increased risk of stroke and other arterial events and the use of bevacizumab may interfere with wound healing. The H&P and CEA were changed from every 3 mo to every 3-6 mo for 2 y ( ). The recommended timing of colonoscopy was changed throughout the guidelines to at 3 y and then every 5 y for patients negative for polyps at the 1 y colonoscopy. Footnotes "v" and "w" are new to the page ( ). A new page was added to address the treatment recommendations for documented metachronous liver and/or lung metastases based upon the timing and type of previous therapy ( ). Principles of Pathologic Review is a new attachment ( ). Principles of Surgery ( ) Principles of Radiation Therapy ( ) Chemotherapy for Advanced or Metastatic Disease ( ): � � � The bullet regarding transanal microsurgery and the recommendation that surgery follow 5-10 weeks after neoadjuvant therapy are new to the page. The first bullet was modified to add "tumors involving anterior structures and the inguinal nodes should be included for tumors invading into the distal anal canal." The fourth bullet regarding IMRT is new to the page. CapeOX was added as a treatment option wherever FOLFOX is listed as an option. FOLFIRI + cetuximab and Irinotecan + cetuximab were added as treatment options with a category 2B designation after first progression following treatment on FOLFOX + bevacizumab or CapeOX + bevacizumab. Panitumumab was added as a treatment option wherever cetuximab is listed as monotherapy. IFL + bevacizumab and the Mayo Clinic 5-FU/LV regimens were removed as treatment recommendations for patients. Capecitabine bevacizumab was added as a treament option with a category 2B designation for patients who cannot tolerate intensive therapy. Footnotes 2-4, 6, 8 and 12-15 are all new to the section to provide guidance for selecting therapy ( ). Footnote 5 was modified to include the mention of the UGT1A1 test available but there are no guidelines established for use in clinical practice. The simplified biweekly infusional 5-FU/LV regimen was added ( ). REC-1 REC-2 REC-4 REC-5 REC-7 REC-7 REC-9 REC-A REC-B REC-D REC-E REC-E 2 of 5 REC-E 4 of 5 ± Rectal Cancer Version 1.2007, 01/02/07 © 2007 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.1.2007 Guidelines Index Rectal Cancer Table of Contents Staging, MS, References Single specimen, completely removed with favorable histological features and clear margins (T1 only) d Observe � � � Pathology review Colonoscopy Marking of cancerous polyp site (at time of colonoscopy or within 2 wks) b,c CLINICAL PRESENTATIONa Pedunculated polyp (adenoma [tubular, tubulovillous, or villous]) with invasive cancer WORKUP FINDINGS Fragmented specimen or margin cannot be assessed or unfavorable histological featuresd See Primary and Adjuvant Treatment (REC-3) a ll Endoscopically removed malignant polyp A patients with colon cancer should be counseled for family history. Patients with suspected hereditary non-polyposis colon cancer (HNPCC), familial adenomatous polyposis (FAP) and attenuated FAP, see the . Confirm the presence of invasive cancer (pT1). pTis has no biological potential to metastasize. It has not been established if molecular markers are useful in treatment determination (predictive markers) and prognosis. College of American Pathologists Consensus Statement 1999. Prognostic factors in colorectal cancer. Arch Pathol Lab Med 2000;124:979-994. - . b c d NCCN Colorectal Cancer Screening Guidelines See Principles of Pathologic Review (REC-A) Back to Other Clinical Presentations (Table of Contents) Single specimen, completely removed with favorable histological features and clear margins (T1 only) d Observe or See Primary Treatment on page REC-3� � � Pathology review Colonoscopy Marking of cancerous polyp site (at time of colonoscopy or within 2 wks) b,cSessile polyp (Adenoma [tubular, tubulovillous, or villous]) with invasive cancer Fragmented specimen or margin cannot be assessed or unfavorable histological featuresd 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. REC-1 See Primary and Adjuvant Treatment (REC-3) Rectal Cancer Version 1.2007, 01/02/07 © 2007 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.1.2007 Guidelines Index Rectal Cancer Table of Contents Staging, MS, References 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. WORKUP CLINICAL STAGE T1-2, N0e � � � � � � � � Biopsy Pathology review Colonoscopy Proctoscopy Chest/abdominal/pelvic CT CEA Endorectal ultrasound or endorectal or pelvic MRI Enterostomal therapist as indicated for preoperative marking of site, teaching a T3, N0 or T any, N1-2 a e All patients with colon cancer should be counseled for family history. Patients with suspected hereditary non-polyposis colon cancer (HNPCC), familial adenomatous polyposis (FAP) and attenuated FAP, see the T1-2, N0 should be based on assessment of endorectal ultrasound or MRI. NCCN Colorectal Cancer Screening Guidelines. CLINICAL PRESENTATION Rectal cancer appropriate for resection See Primary Treatment (REC-6) See Primary Treatment (REC-4) See Primary Treatment (REC-3) T4 and/or locally unresectable See Primary Treatment (REC-4) See Primary Treatment (REC-5) T any, N any, M1 Resectable metastases T any, N any, M1 Unresectable metastases or medically inoperable REC-2 Rectal Cancer Version 1.2007, 01/02/07 © 2007 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.1.2007 Guidelines Index Rectal Cancer Table of Contents Staging, MS, References 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. CLINICAL STAGE PRIMARY TREATMENT T1-2, N0e Transabdominal resection or Transanal excision, if appropriate (category 2B for T2) f f T1-T2, NX; high risk featuresg Trans- abdominal resectionf T1, NX; Margins negative Observe T2, NX; Margins negative Trans- abdominal resection or 5-FU/RT f eT1-2, N0 should be based on assessment of endorectal ultrasound or MRI. High risk features include positive margins, lymphovascular invasion and poorly differentiated tumors. The use of FOLFOX or capecitabine is an extrapolation from the available data in colon cancer. Trials are still pending in rectal cancer.f g i j k h Data regarding the use of capecitabine/RT is limited and no phase III randomized data are available. Trials are pending. Kim J-Sang, Kim J-Sung, Cho, M, et al Preoperative chemoradiation using oral capecitabine in locally advanced rectal cancer. Int J Radiation Oncology Biol Phys 2002;54(2):403-408. See Principles of Surgery (REC-B). See Principles of Radiation Therapy (REC-D). See Principles of Adjuvant Therapy (REC-C). ADJUVANT TREATMENTh,i pT3, N0, M0 or pT1-3, N1-2 pT1-2, N0, M0 Observe 5-FU ± leucovorin , or capecitabine/RT (category 2B), then 5-FU ± leucovorin or FOLFOX jor FOLFOX (category 2B) or capecitabine (category 2B) then continuous 5-FU/RT or bolus 5-FU + leucovorin/RT (category 2B) (category 2B) or capecitabine (category 2B) j k j j REC-3 pT3, N0, M0 or pT1-3, N1-2 pT1–2, N0, M0 Observe 5-FU ± leucovorin , or capecitabine/RT (category 2B), then 5-FU ± leucovorin or FOLFOX or FOLFOX (category 2B) or capecitabine (category 2B) then continuous 5-FU/RT or bolus 5-FU + leucovorin/RT (category 2B) (category 2B) or capecitabine (category 2B) j j j j k Consider systemic chemotherapy Surveillance (See REC-7) Rectal Cancer Version 1.2007, 01/02/07 © 2007 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.1.2007 Guidelines Index Rectal Cancer Table of Contents Staging, MS, References Surveillance (See REC-7) 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. pT3, N0, M0 or pT1-3, N1-2 l,m pT1–2, N0, M0 Observe 5-FU ± leucovorin (category 1) or FOLFOX (category 2B) or Capecitabine (category 2B) j,o j f h i j k l m n o . . . The use of FOLFOX or capecitabine is an extrapolation from the available data in colon cancer. Trials are still pending in rectal cancer. Data regarding the use of capecitabine/RT is limited and no phase III randomized data are available. Trials are pending. Kim J-Sang, Kim J-Sung, Cho, M, et al Preoperative chemoradiation using oral capecitabine in locally advanced rectal cancer. Int J Radiation Oncology Biol Phys 2002;54(2):403-408. The use of agents other than fluoropyrimidines are not recommended concurrently with RT. For patients with proximal T3, N0 disease with clear margins and favorable prognostic features, the incremental benefit of RT is likely to be small. Consider chemotherapy. Postoperative therapy is indicated in all patients who receive preoperative therapy, regardless of the surgical pathology results. An ongoing Intergroup trial compares 5-FU/leucovorin, FOLFOX, and FOLFIRI after surgery. See Principles of Surgery (REC-B) See Principles of Adjuvant Therapy (REC-C) See Principles of Radiation Therapy (REC-D) T3, N0 or T any, N1-2 Preoperative (category 2B) or Transabdominal resection continuous 5-FU/RT (preferred) (category 1 for node positive disease) or bolus 5-FU + leucovorin/RT or capecitabine/RTk e Transabdominal resectionf 5-FU ± leucovorin or then continuous 5-FU/RT or bolus 5-FU + leucovorin/RT (category 2B) (category 2B) then 5-FU ± leucovorin k FOLFOX (category 2B) or capecitabine (category 2B), or capecitabine/RT or FOLFOX (category 2B) or capecitabine (category 2B) j,o j j,o j 5-FU ± leucovorin or FOLFOX (category 2B)j,o Continuous IV 5-FU/RT or capecitabine/RT (category 2B) or bolus 5-FU + leucovorin/RT k Resection, if possible T4 and/or locally unresectable Any T CLINICAL STAGE PRIMARY TREATMENT ADJUVANT TREATMENTh,i,n REC-4 Rectal Cancer Version 1.2007, 01/02/07 © 2007 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.1.2007 Guidelines Index Rectal Cancer Table of Contents Staging, MS, References Surveillance (See REC-7) 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. CLINICAL STAGE PRIMARY TREATMENT ADJUVANT THERAPYh,i Continuous IV 5-FU/ pelvic RT or bolus 5-FU + leucovorin/ + + pelvic RT or Capecitabine/RT (category 2B) or Combination chemotherapy (FOLFOX bevacizumab or FOLFIRI bevacizumab) or Staged or synchronous resection of metastases + rectal lesion k f p Staged or synchronous resection of metastases and rectal lesion f T Any, N Any, M1 Resectable synchronous metastases pT1-2, N0, M1 pT3-4, Any N or Any T, N1-2 Staged or synchronous resection of metastases and rectal lesion f 5-FU ± leucovorin or FOLFOX + bevacizumab (category 2B) or FOLFIRI p p+ bevacizumab (category 2B) Consider continuous IV 5-FU/ pelvic RT or bolus 5-FU + leucovorin/pelvic RT or Capecitabine/RT (category 2B)k 5-FU ± leucovorin or FOLFOX + bevacizumab x 4-6 mo (category 2B) or FOLFIRI + bevacizumab x 4-6 mo p p x 6 mo (category 2B) REC-5 f h i j k o p q . The use of FOLFOX or capecitabine is an extrapolation from the available data in colon cancer. Trials are still pending in rectal cancer. The safety of administering bevacizumab pre or postoperatively, in combination with 5-FU-based regimens, has not been adequately evaluated. There should be at least a 6 wk interval between the last dose of bevacizumab and elective surgery. There is an increased risk of stroke and other arterial events especially in age 65. The use of bevacizumab may interfere with wound healing. RT only recommended for patients at relative risk for pelvic recurrence. Data regarding the use of capecitabine/RT is limited and no phase III randomized data are available. Trials are pending. Kim J-Sang, Kim J-Sung, Cho, M et al Preoperative chemoradiation using oral capecitabine in locally advanced rectal cancer. Int J Radiation Oncology Biol Phys 2002;54(2):403-408. An ongoing Intergroup trial compares 5-FU/leucovorin, FOLFOX, and FOLFIRI after surgery. � See Principles of Surgery (REC-B). See Principles of Adjuvant Therapy (REC-C) See Principles of Radiation Therapy (REC-D). 5-FU