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NCCN Clinical Practice Guidelines in Oncology™  Colon Cancer                   V.1.2010                  Continue         ...
Guidelines IndexNCCN                             ®                                    Practice Guidelines                 ...
Guidelines IndexNCCN                             ®                                    Practice Guidelines                 ...
Guidelines IndexNCCN                            ®                                   Practice Guidelines                   ...
Guidelines IndexNCCN                            ®                                   Practice Guidelines                   ...
Guidelines IndexNCCN                              ®                                     Practice Guidelines               ...
Guidelines IndexNCCN                              ®                                     Practice Guidelines               ...
Guidelines IndexNCCN                              ®                                     Practice Guidelines               ...
Guidelines IndexNCCN                              ®                                     Practice Guidelines               ...
Guidelines IndexNCCN                             ®                                    Practice Guidelines                 ...
Guidelines IndexNCCN                              ®                                     Practice Guidelines               ...
Guidelines IndexNCCN                              ®                                     Practice Guidelines               ...
Guidelines IndexNCCN                              ®                                     Practice Guidelines               ...
Guidelines IndexNCCN                              ®                                     Practice Guidelines               ...
Guidelines IndexNCCN                              ®                                     Practice Guidelines               ...
Guidelines IndexNCCN                              ®                                     Practice Guidelines               ...
Guidelines IndexNCCN                             ®                                    Practice Guidelines                 ...
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  1. 1. NCCN Clinical Practice Guidelines in Oncology™ Colon Cancer V.1.2010 Continue www.nccn.org
  2. 2. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References NCCN Colon Cancer Panel Members* Paul F. Engstrom, MD/Chair † Peter C. Enzinger, MD † David P. Ryan, MD ¤ Fox Chase Cancer Center Dana-Farber/Brigham and Women’s Cancer Center Massachusetts General Hospital Cancer Center Juan Pablo Arnoletti, MD ¶ Marwan G. Fakih, MD † * Leonard Saltz, MD † ‡ Þ University of Alabama at Birmingham Roswell Park Cancer Institute Memorial Sloan-Kettering Cancer Center Comprehensive Cancer Center James Fleshman, Jr., MD ¶ David Shibata, MD ¶* Al B. Benson, III, MD † Siteman Cancer Center at Barnes-Jewish Hospital H. Lee Moffitt Cancer Center and Research Robert H. Lurie Comprehensive Cancer and Washington University School of Medicine Institute at the University of South Florida Center of Northwestern University Charles Fuchs, MD † John M. Skibber, MD ¶ Jordan D. Berlin, MD † Dana-Farber/Brigham and Womens Cancer Center The University of Texas M. D. Anderson Cancer Vanderbilt-Ingram Cancer Center Center Jean L. Grem, MD † J. Michael Berry, MD † UNMC Eppley Cancer Center at The Nebraska William Small, Jr., MD § UCSF Helen Diller Family Comprehensive Medical Center Robert H. Lurie Comprehensive Cancer Center Cancer Center of Northwestern University James A. Knol, MD ¶ Yi-Jen Chen, MD, PhD § University of Michigan Comprehensive Cancer Constantinos T. Sofocleous, MD, PhD ф City of Hope Comprehensive Cancer Center Center Memorial Sloan-Kettering Cancer Center Michael A. Choti, MD ¶ Lucille A. Leong, MD † James Thomas, MD, PhD ‡ The Sidney Kimmel Comprehensive Cancer City of Hope Comprehensive Cancer Center Arthur G. James Cancer Hospital & Richard J. Center at Johns Hopkins Solove Research Institute at The Ohio State Edward Lin, MD † University Harry S. Cooper, MD ¹ Fred Hutchinson Cancer Research Center/Seattle Fox Chase Cancer Center Cancer Care Alliance Alan P. Venook, MD † ‡ UCSF Helen Diller Family Comprehensive Raza A. Dilawari, MD ¶ Mary F. Mulcahy, MD ‡ Cancer Center St. Jude Childrens Research Robert H. Lurie Comprehensive Cancer Center of Hospital/University of Tennessee Cancer Northwestern University Christopher Willett, MD § Institute Duke Comprehensive Cancer Center Eric Rohren, MD, PhD ф Dayna S. Early, MD ¤ The University of Texas M. D. Anderson Cancer † Medical Oncology Siteman Cancer Center at Barnes-Jewish Center § Radiotherapy/Radiation oncology Hospital and Washington University School ¶ Surgery/Surgical oncology of Medicine ¹ Pathology Continue ‡ Hematology/Hematology Oncology Þ Internal medicine NCCN Guidelines Panel Disclosures ¤ Gastroenterology ф Diagnostic/Interventional Radiology *Writing Committee Member Version 1.2010, 12/11/09 © 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 IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesTable of ContentsNCCN Colon Cancer Panel Members For help using theseSummary of the Guidelines Updates documents, please click hereClinical Presentations and Primary Treatment:· Pedunculated polyp (adenoma [tubular, tubulovillous, or villous]) with invasive Staging cancer (COL-1) Discussion· Sessile polyp (adenoma [tubular, tubulovillous, or villous]) with invasive References cancer (COL-1)· Colon cancer appropriate for resection (COL-2) Clinical Trials: The NCCN· Suspected or proven metastatic adenocarcinoma from the large bowel (COL-5) believes that the best managementPathologic Stage, Adjuvant Therapy and Surveillance (COL-3) for any cancer patient is in a clinicalRecurrence and Workup (COL-9) trial. Participation in clinical trials isPrinciples of Pathologic Review (COL-A) especially encouraged.Principles of Surgery (COL-B) To find clinical trials online at NCCN member institutions, click here:Chemotherapy for Advanced or Metastatic Disease (COL-C) nccn.org/clinical_trials/physician.htmlPrinciples of Risk Assessment for Stage II Disease (COL-D) NCCN Categories of Evidence andPrinciples of Adjuvant Therapy (COL-E) Consensus: All recommendationsPrinciples of Radiation Therapy (COL-F) are Category 2A unless otherwisePrinciples of Survivorship (COL-G) specified. See NCCN Categories of Evidence and ConsensusGuidelines IndexPrint the Colon Cancer 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 or warranties of any kind, 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 1.2010, 12/11/09 © 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 IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesSummary of the Guidelines updatesSummary changes in the 1.2010 version of the Colon Guidelines from the 3.2009 version include:Global Changes· PET scan changed to PET-CT scan throughout.COL-2· Footnote “g” is new to the page, “PET-CT does not supplant a contrast-enhanced diagnostic CT scan.”COL-3· Footnote “l” is new to the page, “Bevacizumab, cetuximab, panitumumab, or irinotecan should not be used in the adjuvant setting for stage II or III patients outside the setting of a clinical trial.” (also applies to COL-4)· Footnote “m” is new to the page, “Testing for mismatch repair proteins (MMR) should be considered for all patients < 50 years of age.” (also applies to COL-4)COL-5· Consideration of BRAF gene status was added to the workup recommendations as an option, if KRAS is non-mutated.· Footnote “w” was clarified that IV contrast should be used for a CT or MRI.COL-6· Footnote “y” is new to the page, “Patients with a known V600E BRAF mutation appear to be unlikely to benefit from anti-EGFR monoclonal antibodies.” (also applies for COL-7, COL-10, and COL-11)COL-9· Footnote “cc” modified to include consideration of BRAF testing as an option, if KRAS is non-mutated. (also applies to COL-10)COL-10· If a patient remains unresectable after primary treatment, the recommendation of “observation” was removed. (also applies to COL-11)COL-A 3 of 4· New section added for BRAF testing.COL-B 2 of 3· Bullet 8 modified to “Conformal external beam radiation therapy may be considered in highly selected cases or in the setting of a clinical trial and should not be used indiscriminately in patients who are potentially surgically resectable.”COL-C 1 of 6· Footnote “2” is new to the page, “PET-CT should not be used to monitor progress of therapy. CT with contrast or MRI is recommended.” (also applies to COL-C 2 of 6)· Footnote “9” is new to the page, “Patients with a known V600E BRAF mutation appear to be unlikely to benefit from anti-EGFR monoclonal antibodies.”COL-C 2 of 6· Panitumumab (KRAS WT gene only) was added as an option for patients not appropriate for intensive therapy with a category 2B designation.COL-C 3 of 6· Footnotes “2” and “9” are new to the page as noted above.· Hecht reference in footnote “6” updated.Version 1.2010, 12/11/09 © 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 IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesSummary of the Guidelines updatesSummary changes in the 1.2010 version of the Colon Guidelines from the 3.2009 version include:COL-C 4 of 6· Notation added “Bevacizumab may be safely given at a rate of 0.5 mg/kg/minute (5 mg/kg over 10 minutes and 7.5 mg/kg over 15 minutes)”· FOLFOX 4 (Goldberg reference) and FOLFIRI (Douillard reference) regimens removed from the options for chemotherapy regimens.· Footnote modified relating to levoleucovorin, “While used in Europe, levoleucovorin is not approved for colorectal cancer in the United States. Leucovorin 400 mg/m 2 is the equivalent of levoleucovorin 200 mg/m 2.” (also applies for COL-C 5 of 6, and COL-E 1 of 3)COL-C 5 of 6· Bolus 5-FU/leucovorin (de Gramont reference) regimen removed from the options for chemotherapy regimens.· Irinotecan dosing regimen changed from 4 weeks on and 2 weeks off, to 2 weeks on and 1 week off.COL-D· The following bullet was added to the Principles of Risk Assessment, “If considering only fluoropyrimidine therapy, MMR testing recommended. See NCCN Colorectal Screening Guidelines.”COL-E 1 of 3· FOLFOX 4 (Andre reference) and bolus 5-FU/leucovorin (IMPACT reference) regimens removed from the options for chemotherapy regimens.· Simplified LV5FU2 (Andre reference) added as a regimen option.COL-E 2 of 3· Cassidy reference in footnote “5” added.COL-E 3 of 3· Bullet 2 modified to note “FOLFOX is superior to fluoropyrimidine therapy alone for stage III patients.”· Bullet 4 added, “Bevacizumab, cetuximab, panitumumab, or irinotecan should not be used in the adjuvant setting for stage II or III patients outside the setting of a clinical trial.”COL-F· Bullet 3 modified to note that “conformal external beam radiation should be routinely used” and IMRT “reserved” only “for unique clinical situations.”· Bullet 4 - If IORT not available, “additional 10-20 Gy” replaced “low dose.” Clarification added with the addition of “to a limited volume.”COL-G 2 of 3· References 4-6 added.Version 1.2010, 12/11/09 © 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
  6. 6. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesCLINICAL WORKUP FINDINGS SURGERYPRESENTATION a Single specimen, completely removed with · Pathology review b,c Observe favorable histologicalPedunculated polyp · Colonoscopy features d and clear margins(adenoma [tubular, · Marking of See Pathologictubulovillous, or cancerous polyp site Stage, Adjuvantvillous]) with invasive Therapy, and (at time of Surveillancecancer colonoscopy or Fragmented specimen or Colectomy e with en (COL-3) within 2 wks) margin cannot be bloc removal of assessed or unfavorable regional lymph nodes histological features d Observe f Single specimen, or completely removed with · Pathology review b,c Colectomy e with en favorable histologicalSessile polyp · Colonoscopy bloc removal of features d and clear margins See Pathologic(adenoma [tubular, · Marking of regional lymph nodes Stage, Adjuvanttubulovillous, or cancerous polyp site Therapy, andvillous]) with invasive (at time of Surveillancecancer colonoscopy or (COL-3) Fragmented specimen or within 2 wks) Colectomy e with en margin cannot be bloc removal of assessed or unfavorable regional lymph nodes histological features da 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 NCCN Colorectal Cancer Screening Guidelines.b Confirm the presence of invasive cancer (pT1). pTis has no biological potential to metastasize.c 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.d See Principles of Pathologic Review (COL-A) - Endoscopically removed malignant polyp.e See Principles of Surgery (COL-B 1 of 3).f Observation may be considered, with the understanding that there is an added 10-15% risk of lymph node metastases. Nivatvongs S, Back to Other Clinical Rojanasakul A, Reiman HM, et al. The risk of lymph node metastasis in colorectal polyps with invasive adenocarcinoma. Dis Colon Rectum Presentations 1991;34(4):323-8. (Table of Contents) 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 1.2010, 12/11/09 © 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. COL-1
  7. 7. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesCLINICAL WORKUP FINDINGS SURGERYPRESENTATION a Colectomy e with en Resectable, bloc removal of nonobstructing regional lymph nodes See · Pathology review d One-stage colectomy e Pathologic · Colonoscopy with en bloc removal of Stage, · CBC, platelets, AdjuvantColon cancer regional lymph nodes Resectable, Therapy, andappropriate for chemistry profile, or Surveillance CEA obstructing Resection with diversion (COL-3)resection (nonmetastatic) · Chest/abdominal/ (unprepped) or pelvic CT Stent Colectomy e with en · PET-CT scan is not or bloc removal of routinely indicated g Diversion regional lymph nodes Locally See Chemotherapy unresectable Palliative for Advanced or or medically therapy h Metastatic Disease inoperable (COL-C)Suspected or proven metastatic See Management of suspected oradenocarcinoma from large bowel proven metastases (COL-5)a Allpatients 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 NCCN Colorectal Cancer Screening Guidelines.d See Principles of Pathologic Review (COL-A) - Colon cancer appropriate for resection, pathological stage, and lymph node evaluation.e See Principles of Surgery (COL-B 1 of 3). Back to Other Clinicalg PET-CT does not supplant a contrast-enhanced diagnostic CT scan. Presentationsh Palliative therapy may include RT for uncontrolled bleeding, stent for obstruction, supportive care. (Table of Contents) 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 1.2010, 12/11/09 © 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. COL-2
  8. 8. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesPATHOLOGIC STAGE d ADJUVANT THERAPY i,k,l,m SURVEILLANCE rTis; T1, N0, M0; · History and physical every 3-6 mo for 2 y, NoneT2, N0, M0 then every 6 mo for a total of 5 y Consider capecitabine n,o · CEA s every 3-6 mo for 2 y, then every 6 mo or 5-FU/leucovorin n,o for a total of 5 y for T2 or greater lesionsT3, N0, M0 j or · Chest/abdominal/pelvic CT annually x 3 y(no high risk features) Clinical trial for patients at high risk for recurrence r,t or · Colonoscopy a in 1 y except if no See Observation n RecurrenceT3, N0, M0 at high risk for preoperative colonoscopy due tosystemic recurrence (grade obstructing lesion, colonoscopy in and Workup 5-FU/leucovorin/oxaliplatin n,o,p,q or (COL-9)3-4, lymphatic/vascular 3-6 mo capecitabine n,o,q or 5-FU/leucovorin n,o,q > If advanced adenoma, repeat in 1 yinvasion, bowel obstruction, or > If no advanced adenoma, u repeat in 3 y,< 12 lymph nodes examined) Clinical trialor T4, N0, M0; or T3 with then every 5 y v orlocalized perforation or Observation n · PET-CT scan is not routinelyclose, indeterminate or recommendedpositive margins · See Principles of Survivorship (COL-G)Node positive disease, see page COL-4a All patients with colon cancer should be counseled for family history. Patients with n See Principles of Risk Assessment for Stage II Disease (COL-D). suspected hereditary non-polyposis colon cancer (HNPCC), familial adenomatous o See Principles of Adjuvant Therapy (COL-E). polyposis (FAP) and attenuated FAP see the NCCN Colorectal Cancer Screening p Treatment options include FOLFOX (infusional 5-FU, leucovorin, oxaliplatin) or Guidelines. FLOX (bolus 5-FU, leucovorin, oxaliplatin). Grade 3-4 diarrhea is considerablyd See Principles of Pathologic Review (COL-A) - Pathological stage. higher with FLOX than FOLFOX in cross study comparison.i There are no data to support adjuvant therapy in Stage I disease, however certain q Consider RT for T4 with penetration to a fixed structure. See Principles of high risk Stage II patients (lymphovascular invasion, poorly differentiated histology, Radiation Therapy COL-F. inadequate lymph node sampling) may be considered at higher risk and a r Desch CE, Benson III AB, Somerfield MR, et al. Colorectal cancer surveillance: discussion of chemotherapy may be warranted. 2005 update of the American Society of Clinical Oncology Practice Guideline. Jj Patients considered to be N0 but who have < 12 nodes examined are suboptimally Clin Oncol 2005;23:8512-8519. staged and should be considered in the high risk group. See Principles of s If patient is a potential candidate for further intervention. Pathologic Review (COL-A) - Lymph node evaluation. t CT scan may be useful for patients at high risk for recurrence (eg, lymphatic ork There are insufficient data to recommend the use of multi-gene assay panels to venous invasion by tumor, or poorly differentiated tumors). determine adjuvant therapy. u Villous polyp, polyp > 1 cm, or high grade dysplasia.l Bevacizumab, cetuximab, panitumumab, or irinotecan should not be used in the v Rex DK, Kahi CJ, Levin B, et al. Guidelines for colonoscopy surveillance after adjuvant setting for stage II or III patients outside the setting of a clinical trial. cancer resection: a consensus update by the American Cancer Society and them Testing for mismatch repair proteins (MMR) should be considered for all patients US Multi-Society Task Force on Colorectal Cancer. Gastroenterology < 50 years of age. 2006;130:1865-71. 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 1.2010, 12/11/09 © 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. COL-3
  9. 9. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesPATHOLOGIC STAGE d ADJUVANT THERAPY k,l,m SURVEILLANCE r · History and physical every 3-6 mo for 2 y, then every 6 mo for a total of 5 y · CEA s every 3-6 mo for 2 y, then every 6 mo for a total of 5 y for T2 or greater lesions · Chest/abdominal/pelvic CT annually x 3 y 5-FU/leucovorin/oxaliplatin for patients at high risk for recurrence r,t (category1) o,p,q SeeT1-3, N1-2, M0 · Colonoscopy a in 1 y except if no or Recurrenceor T4, N1-2, M0 Capecitabine o,q preoperative colonoscopy due to and Workup or obstructing lesion, colonoscopy in (COL-9) 5-FU/leucovorin o,q 3-6 mo > If advanced adenoma, repeat in 1 y > If no advanced adenoma, u repeat in 3 y, then every 5 y v · PET-CT scan is not routinely recommended · See Principles of Survivorship (COL-G)a All patients with colon cancer should be counseled for family history. Patients with q Consider RT for T4 with penetration to a fixed structure. See Principles of suspected hereditary non-polyposis colon cancer (HNPCC), familial adenomatous Radiation Therapy COL-F. polyposis (FAP) and attenuated FAP see the NCCN Colorectal Cancer Screening r Desch CE, Benson III AB, Somerfield MR, et al. Colorectal cancer surveillance: Guidelines. 2005 update of the American Society of Clinical Oncology Practice Guideline. Jd See Principles of Pathologic Review (COL-A) - Pathological stage. Clin Oncol 2005;23:8512-8519.k There are insufficient data to recommend the use of multi-gene assay panels to s If patient is a potential candidate for further intervention. determine adjuvant therapy. t CT scan may be useful for patients at high risk for recurrence (eg, lymphatic orl Bevacizumab, cetuximab, panitumumab, or irinotecan should not be used in the venous invasion by tumor, or poorly differentiated tumors). adjuvant setting for stage II or III patients outside the setting of a clinical trial. u Villous polyp, polyp > 1 cm, or high grade dysplasia.m Testing for mismatch repair proteins (MMR) should be considered for all patients v Rex DK, Kahi CJ, Levin B, et al. Guidelines for colonoscopy surveillance after < 50 years of age. cancer resection: a consensus update by the American Cancer Society and theo See Principles of Adjuvant Therapy (COL-E). US Multi-Society Task Force on Colorectal Cancer. Gastroenterologyp Treatment options include FOLFOX (infusional 5-FU, leucovorin, oxaliplatin) or 2006;130:1865-71. FLOX (bolus 5-FU, leucovorin, oxaliplatin). Grade 3-4 diarrhea is considerably higher with FLOX than FOLFOX in cross study comparison. 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 1.2010, 12/11/09 © 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. COL-4
  10. 10. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesCLINICAL WORKUP FINDINGSPRESENTATION See Treatment Resectable e and Adjuvant Therapy (COL-6) · Colonoscopy Synchronous · Chest/abdominal/pelvic CT w liver only or · CBC, platelets, chemistry profile lung only · CEA metastases UnresectableSuspected or · Determination of tumor KRAS gene See Treatment (potentiallyproven metastatic status (if KRAS non-mutated, and Adjuvant convertible e orsynchronous consider BRAF testing) d Therapy (COL-7) unconvertible)adenocarcinoma · Needle biopsy, if clinically indicatedfrom large bowel · PET-CT scan only if potentially(Any T, any N, M1) surgically curable M1 disease · Multidisciplinary team evaluation, Synchronous See Primary including a surgeon experienced in abdominal/peritoneal Treatment and the resection of hepatobiliary and Adjuvant Therapy lung metastases metastases (COL-8)d See Principles of Pathologic Review (COL-A 3 of 4) - KRAS and BRAF Mutation Testing.e See Principles of Surgery (COL-B 2 of 3).w CT should be with IV contrast. Consider MRI with IV contrast if CT is inadequate. 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 1.2010, 12/11/09 © 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. COL-5
  11. 11. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesTREATMENT ADJUVANT THERAPY SURVEILLANCE (resected metastatic disease)Resectable e synchronous liver (6 mo perioperative treatment preferred)and/or lung metastases onlyColectomy, with synchronous or staged liver or lung If patient stage IV, NED:resection · CEA every 3 mo x 2 y, then everyor Active chemotherapy regimen 6 mo x 3-5 yNeoadjuvant therapy (for 2-3 months) for advanced disease (See · Chest/abdominal/pelvic CT scanFOLFIRI or FOLFOX or CapeOX w ± bevacizumab x or Chemotherapy for Advanced or every 3-6 mo x 2 y, then every 6-FOLFIRI or FOLFOX or CapeOX w ± cetuximab (KRAS Metastatic Disease (COL-C) z,aa 12 mo up to a total of 5 ywild-type gene only) d,y followed by synchronous or (category 2B) · Colonoscopy a in 1 y except if no Recurrencestaged colectomy and resection of metastatic disease or preoperative colonoscopy due (See COL-9)or Consider observation or to obstructing lesion,Colectomy, followed by chemotherapy (for 2-3 months) shortened course of colonoscopy in 3-6 moFOLFIRI or FOLFOX or CapeOX w ± bevacizumab x or chemotherapy, if patient > If advanced adenoma, repeatFOLFIRI or FOLFOX or CapeOX w ± cetuximab (KRAS received neoadjuvant therapy in 1 ywild-type gene only) d,y and staged resection of > If no advanced adenoma, umetastatic disease repeat in 3 y, then every 5 y va 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 NCCN Colorectal Cancer Screening Guidelines.d See Principles of Pathologic Review (COL-A 3 of 4) - KRAS and BRAF Mutation Testing.e See Principles of Surgery (COL-B 2 of 3).u Villous polyp, polyp > 1 cm, or high grade dysplasia.v Rex DK, Kahi CJ, Levin B, et al. Guidelines for colonoscopy surveillance after cancer resection: a consensus update by the American Cancer Society and the US Multi- Society Task Force on Colorectal Cancer. Gastroenterology 2006;130(6):1865-71.w The majority of safety and efficacy data for this regimen have been developed in Europe, where a capecitabine starting dose of 1000 mg/m 2 twice daily for 14 days, repeated every 21 days, is standard. Evidence suggests that North American patients may experience greater toxicity with capecitabine (as well as with other fluoropyrimidines) than European patients, and may require a lower dose of capecitabine. The relative efficacy of CapeOx with lower starting doses of capecitabine has not been addressed in large scale randomized trials.x 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 and re-initiation of bevacizumab at least 6-8 weeks postoperatively. There is an increased risk of stroke and other arterial events especially in age ³ 65. The use of bevacizumab may interfere with wound healing.y Patients with a known V600E BRAF mutation appear to be unlikely to benefit from anti-EGFR monoclonal antibodies.z Hepatic artery infusion ± systemic 5-FU/leucovorin (category 2B) is also an option at institutions with experience in both the surgical and medical oncologic aspects of this procedure.aa FOLFOXIRI is not recommended in this setting. 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 1.2010, 12/11/09 © 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. COL-6
  12. 12. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesTREATMENT ADJUVANT THERAPY SURVEILLANCE (6 mo perioperativeUnresectable synchronous liver treatment preferred) If patient stage IV, NED:and/or lung metastases only · CEA every 3 mo x 2 y, Active chemotherapy then every 6 mo x 3-5 y regimen for advanced · Chest/abdominal/pelvic disease (See CT scan every 3-6 mo x Synchronized Chemotherapy for 2 y, then every 6-12 mo· Systemic therapy or staged Advanced or Metastatic up to a total of 5 y (FOLFIRI or FOLFOX Re-evaluate for Converted to resection e of Disease (COL-C) z · Colonoscopy a in 1 y conversion to resectable e colon and (category 2B) except if no preoperative or CapeOX w ± bevacizumab x resectable e every metastatic or colonoscopy due to or FOLFIRI or FOLFOX or obstructing lesion, 2 mo if conversion cancer Consider observation CapeOX w ± cetuximab [KRAS Remains colonoscopy in 3-6 mo to resectability is or shortened course of wild-type gene only] d,y or unresectable > If advanced adenoma, a reasonable goal chemotherapy, if FOLFOXIRI [category 2B]) repeat in 1 y patient received· Consider colon resection e > If no advanced See Chemotherapy for neoadjuvant therapy adenoma, u repeat in only if imminent risk of Advanced or Metastatic 3 y, then every 5 y v obstruction or significant Disease (COL-C) bleeding Recurrence (See COL-9)a 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 NCCN Colorectal Cancer Screening Guidelines.d See Principles of Pathologic Review (COL-A 3 of 4) - KRAS and BRAF Mutation Testing.e See Principles of Surgery (COL-B 2 of 3).u Villous polyp, polyp > 1 cm, or high grade dysplasia.v Rex DK, Kahi CJ, Levin B, et al. Guidelines for colonoscopy surveillance after cancer resection: a consensus update by the American Cancer Society and the US Multi- Society Task Force on Colorectal Cancer. Gastroenterology 2006;130(6):1865-71.w The majority of safety and efficacy data for this regimen have been developed in Europe, where a capecitabine starting dose of 1000 mg/m 2 twice daily for 14 days, repeated every 21 days, is standard. Evidence suggests that North American patients may experience greater toxicity with capecitabine (as well as with other fluoropyrimidines) than European patients, and may require a lower dose of capecitabine. The relative efficacy of CapeOx with lower starting doses of capecitabine has not been addressed in large scale randomized trials.x 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 and re-initiation of bevacizumab at least 6-8 weeks postoperatively. There is an increased risk of stroke and other arterial events especially in age ³ 65. The use of bevacizumab may interfere with wound healing.y Patients with a known V600E BRAF mutation appear to be unlikely to benefit from anti-EGFR monoclonal antibodies.z Hepatic artery infusion ± systemic 5-FU/leucovorin (category 2B) is also an option at institutions with experience in both the surgical and medical oncologic aspects of this procedure. 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 1.2010, 12/11/09 © 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. COL-7
  13. 13. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesFINDINGS PRIMARY TREATMENT See Chemotherapy for Nonobstructing Advanced or Metastatic Disease (COL-C)Synchronousabdominal/peritoneal Colon resection emetastases bb or Diverting colostomy Obstructed See Chemotherapy for or or imminent Advanced or Metastatic Bypass of impending obstruction Disease (COL-C) obstruction or Stentinge See Principles of Surgery (COL-B 2 of 3).bb Aggressive cytoreductive debulking and/or intraperitoneal chemotherapy are not recommended outside the setting of a 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 1.2010, 12/11/09 © 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. COL-8
  14. 14. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, ReferencesRECURRENCE WORKUP Negative · Consider PET-CT scan findings Negative · Reevaluate chest/ · Physical exam findings abdominal/pelvic CT · Colonoscopy See treatment forSerial in 3 mo Positive Documented · Chest/abdominal/CEA findings metachronous pelvic CTelevation metastases COL-10 · Consider PET-CT See treatment for scan Positive Documented findings metachronous metastases COL-10Documented See treatment formetachronous Documentedmetastases cc by CT, metachronousMRI and/or biopsy metastases COL-10cc Determination of tumor KRAS (if KRAS non-mutated, consider BRAF testing). See Principles of Pathologic Review (COL-A 3 of 4) - KRAS and BRAF Mutation Testing. 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 1.2010, 12/11/09 © 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. COL-9
  15. 15. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References PRIMARY TREATMENT See Primary Resectable f Treatment COL-11Documentedmetachronous Activemetastases cc,dd FOLFIRI ± chemotherapyby CT, MRI bevacizumab Converted to regimen eeand/or biopsy · Previous adjuvant or Resection z FOLFIRI ± resectable e (See COL-C) FOLFOX within Re-evaluate for or past 12 months cetuximab conversion to Observation (KRAS WT resectable e every Unresectable gene only) d,y 2 mo if conversion (potentially · Previous adjuvant to resectability is convertible e or FOLFOX > 12 Active a reasonable goal unconvertible) Remains Active chemotherapy months chemotherapy · Previous 5-FU/LV regimen unresectable regimen (See COL-C) or capecitabine (See COL-C) · No previous chemotherapyd See Principles of Pathologic Review (COL-A 3 of 4) - KRAS and BRAF Mutation Testing.e See Principles of Surgery (COL-B 2 of 3).y Patients with a known V600E BRAF mutation appear to be unlikely to benefit from anti-EGFR monoclonal antibodies.z Hepatic artery infusion ± systemic 5-FU/leucovorin (category 2B) is also an option at institutions with experience in both the surgical and medical oncologic aspects of this procedure.cc Determination of tumor KRAS (if KRAS non-mutated, consider BRAF testing). See Principles of Pathologic Review (COL-A 3 of 4) - KRAS and BRAF Mutation Testing.dd Patients should be evaluated by a multidisciplinary team including surgical consultation for potentially resectable patients.ee Total perioperative therapy should be considered for a maximum of 6 months. 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 1.2010, 12/11/09 © 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. COL-10
  16. 16. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References PRIMARY TREATMENT Resection z Active chemotherapy regimen ee (See COL-C) or Repeat initial Response No previous Neoadjuvant chemotherapy chemotherapy chemotherapy Resection z Active (2-3 mo) chemotherapy (See COL-C) regimen ee No response Resectable e (See COL-C) Active chemotherapy or Resection z regimen ee (See COL-C) Observation or or Observation Repeat initial Response Previous Neoadjuvant chemotherapy chemotherapy chemotherapyResectable e,dd Consider Resection z Active (2-3 mo) chemotherapymetachronous PET-CT (See COL-C)metastases scan regimen ee No response FOLFIRI ± (See COL-C) bevacizumab or · Previous adjuvant Observation or Re-evaluate for FOLFOX within FOLFIRI ± cetuximab Converted to past 12 months conversion to resectable e (KRAS WT gene resectable e every · Previous adjuvant only) d,y Active Unresectable 2 mo if conversion FOLFOX > 12 Active to resectability is chemotherapy months Unresectable chemotherapy a reasonable goal regimen · Previous 5-FU/LV regimen (See COL-C) or capecitabine (See COL-C) · No previous chemotherapyd See Principles of Pathologic Review (COL-A 3 of 4) - KRAS and z Hepatic artery infusion ± systemic 5-FU/leucovorin (category 2B) is also an option at institutions BRAF Mutation Testing. with experience in both the surgical and medical oncologic aspects of this procedure.e See Principles of Surgery (COL-B 2 of 3). dd Patients should be evaluated by a multidisciplinary team including surgical consultation fory Patients with a known V600E BRAF mutation appear to be unlikely potentially resectable patients. to benefit from anti-EGFR monoclonal antibodies. ee Total perioperative therapy should be considered for a maximum of 6 months. 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 1.2010, 12/11/09 © 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. COL-11
  17. 17. Guidelines IndexNCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References PRINCIPLES OF PATHOLOGIC REVIEW (1 of 4) Endoscopically removed malignant polyps · A malignant polyp is defined as one with cancer invading through the muscularis mucosae and into the submucosa (pT1). pTIS is not considered a “malignant polyp.” · Favorable histological features: grade 1 or 2, no angiolymphatic invasion and negative margin of resection. There is no consensus as to the definition of what constitutes a positive margin of resection. A positive margin has been defined as 1) tumor < 1 mm from the transected margin, 2) tumor < 2 mm from the transected margin, 3) tumor cells present within the diathermy of the transected margin. 1-4 · Unfavorable histological features: grade 3 or 4, or angiolymphatic invasion, or a “positive margin.” - see positive margin definition above. · There is controversy as to whether malignant colorectal polyps with a sessile configuration can be successfully treated by endoscopic removal. The literature seems to indicate that endoscopically removed sessile malignant polyps have a significantly greater incidence of adverse outcomes (residual disease, recurrent disease, mortality, hematogenous metastasis, but not lymph node metastasis) than do polypoid malignant polyps. However, when one closely looks at the data, configuration by itself is not a significant variable for adverse outcome and endoscopically removed malignant sessile polyps with grade I or II histology, negative margin, and no lymphovascular invasion can be successfully treated with endoscopic polypectomy. 3-7 Colon cancer appropriate for resection · Histological confirmation of primary colonic malignant neoplasm Pathological stage · The following parameters should be reported. > Grade of the cancer > Depth of penetration, (T) > Number of lymph nodes evaluated and number positive (N) > Status of proximal, distal, and radial margins 8-9 See Staging (ST-1)See Lymph node evaluation and sentinel See KRAS and BRAF Mutationlymph node on page 2 of 4 COL-A Testing page 3 of 4 COL-A See footnotes on page 4 of 4 COL-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 1.2010, 12/11/09 © 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. COL-A 1 of 4
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