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NCCN Clinical Practice Guidelines in Oncology™



  Colon Cancer
                   V.1.2010




                  Continue

                www.nccn.org
Guidelines Index

NCCN
                             ®
                                    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 Women's 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 Children's 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.
Guidelines Index

NCCN
                             ®
                                    Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                    in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References



Table of Contents

NCCN Colon Cancer Panel Members                                                                                                                                          For help using these
Summary of the Guidelines Updates                                                                                                                                        documents, please click here
Clinical 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 management
Pathologic Stage, Adjuvant Therapy and Surveillance (COL-3)                                                                                                              for any cancer patient is in a clinical
Recurrence and Workup (COL-9)                                                                                                                                            trial. Participation in clinical trials is
Principles 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.html
Principles of Risk Assessment for Stage II Disease (COL-D)
                                                                                                                                                                         NCCN Categories of Evidence and
Principles of Adjuvant Therapy (COL-E)                                                                                                                                   Consensus: All recommendations
Principles of Radiation Therapy (COL-F)                                                                                                                                  are Category 2A unless otherwise
Principles of Survivorship (COL-G)                                                                                                                                       specified.
                                                                                                                                                                         See NCCN Categories of Evidence
                                                                                                                                                                         and Consensus
Guidelines Index
Print 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.
Guidelines Index

NCCN
                            ®
                                   Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                   in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References

Summary of the Guidelines updates
Summary 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
Guidelines Index

NCCN
                            ®
                                   Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                   in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References

Summary of the Guidelines updates
Summary 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
Guidelines Index

NCCN
                              ®
                                     Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                     in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References


CLINICAL                                          WORKUP                                                FINDINGS                                                   SURGERY
PRESENTATION a

                                                                                                        Single specimen,
                                                                                                        completely removed with
                                               · Pathology review b,c                                                                                              Observe
                                                                                                        favorable histological
Pedunculated polyp                             · Colonoscopy                                            features d and clear margins
(adenoma [tubular,                             · Marking of                                                                                                                                                        See Pathologic
tubulovillous, or                                cancerous polyp site                                                                                                                                              Stage, Adjuvant
villous]) with invasive                                                                                                                                                                                            Therapy, and
                                                 (at time of
                                                                                                                                                                                                                   Surveillance
cancer                                           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 histological
Sessile polyp                                  · Colonoscopy                                                                                                       bloc removal of
                                                                                                        features d and clear margins                                                                               See Pathologic
(adenoma [tubular,                             · Marking of                                                                                                        regional lymph nodes                            Stage, Adjuvant
tubulovillous, or                                cancerous polyp site                                                                                                                                              Therapy, and
villous]) with invasive                          (at time of                                                                                                                                                       Surveillance
cancer                                           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 d
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.
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
Guidelines Index

NCCN
                              ®
                                     Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                     in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References


CLINICAL                          WORKUP                                                FINDINGS                               SURGERY
PRESENTATION 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,                                                                                                                                                                           Adjuvant
Colon cancer                                                                                                                   regional lymph nodes
                                                                                        Resectable,                                                                                                                           Therapy, and
appropriate for                     chemistry profile,                                                                         or                                                                                             Surveillance
                                    CEA                                                 obstructing                            Resection with diversion                                                                       (COL-3)
resection (non
metastatic)                       · 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 or
adenocarcinoma 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 Clinical
g PET-CT does not supplant a contrast-enhanced diagnostic CT scan.                                                                            Presentations
h 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
Guidelines Index

NCCN
                              ®
                                     Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                     in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References


PATHOLOGIC STAGE d                                    ADJUVANT THERAPY i,k,l,m                                                              SURVEILLANCE r
Tis; T1, N0, M0;                                                                                                                            · History and physical every 3-6 mo for 2 y,
                                                      None
T2, 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 lesions
T3, 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                                                                                                                                                           Recurrence
T3, N0, M0 at high risk for                                                                                                                   preoperative colonoscopy due to
systemic 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 y
invasion, bowel obstruction,
                                                      or                                                                                      > If no advanced adenoma, u repeat in 3 y,
< 12 lymph nodes examined)
                                                      Clinical trial
or T4, N0, M0; or T3 with                                                                                                                       then every 5 y v
                                                      or
localized perforation or
                                                      Observation n                                                                         · PET-CT scan is not routinely
close, indeterminate or                                                                                                                       recommended
positive margins                                                                                                                            · See Principles of Survivorship (COL-G)
Node positive disease, see page COL-4

a 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 considerably
d 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. J
j 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 or
k 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 the
m 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
Guidelines Index

NCCN
                              ®
                                     Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                     in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References


PATHOLOGIC 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                                                                                                                                                  See
T1-3, N1-2, M0                                                                                                                            · Colonoscopy a in 1 y except if no
                                                           or                                                                                                                                                                 Recurrence
or 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. J
d 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 or
l 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 the
o See Principles of Adjuvant Therapy (COL-E).                                                                                US Multi-Society Task Force on Colorectal Cancer. Gastroenterology
p 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
Guidelines Index

NCCN
                             ®
                                    Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                    in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References


CLINICAL                                  WORKUP                                                                      FINDINGS
PRESENTATION



                                                                                                                                                                                                                  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
                                                                                                                                                         Unresectable
Suspected or                            · Determination of tumor KRAS gene                                                                                                                                        See Treatment
                                                                                                                                                         (potentially
proven metastatic                         status (if KRAS non-mutated,                                                                                                                                            and Adjuvant
                                                                                                                                                         convertible e or
synchronous                               consider BRAF testing) d                                                                                                                                                Therapy (COL-7)
                                                                                                                                                         unconvertible)
adenocarcinoma                          · Needle biopsy, if clinically indicated
from 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
Guidelines Index

NCCN
                              ®
                                     Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                     in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References


TREATMENT                                                                                          ADJUVANT THERAPY                   SURVEILLANCE
                                                                                                   (resected metastatic disease)
Resectable e synchronous liver                                                                     (6 mo perioperative treatment preferred)
and/or lung metastases only

Colectomy, with synchronous or staged liver or lung                                                                                                            If patient stage IV, NED:
resection                                                                                                                                                      · CEA every 3 mo x 2 y, then every
or                                                                                                   Active chemotherapy regimen                                 6 mo x 3-5 y
Neoadjuvant therapy (for 2-3 months)                                                                 for advanced disease (See                                 · Chest/abdominal/pelvic CT scan
FOLFIRI 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 y
wild-type gene only) d,y followed by synchronous or                                                  (category 2B)                                             · Colonoscopy a in 1 y except if no                            Recurrence
staged 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 mo
FOLFIRI or FOLFOX or CapeOX w ± bevacizumab x or                                                     chemotherapy, if patient                                    > If advanced adenoma, repeat
FOLFIRI or FOLFOX or CapeOX w ± cetuximab (KRAS                                                      received neoadjuvant therapy                                  in 1 y
wild-type gene only) d,y and staged resection of                                                                                                                 > If no advanced adenoma, u
metastatic disease                                                                                                                                                 repeat in 3 y, then every 5 y v
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.
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
Guidelines Index

NCCN
                              ®
                                     Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                     in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References


TREATMENT                                                                                                                                              ADJUVANT THERAPY                              SURVEILLANCE
                                                                                                                                                       (6 mo perioperative
Unresectable 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
Guidelines Index

NCCN
                              ®
                                     Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                     in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References


FINDINGS                                                                                                                      PRIMARY TREATMENT




                                                                                                                              See Chemotherapy for
                                     Nonobstructing                                                                           Advanced or Metastatic
                                                                                                                              Disease (COL-C)

Synchronous
abdominal/
peritoneal                                                                                                                    Colon resection e
metastases bb                                                                                                                 or
                                                                                                                              Diverting colostomy
                                     Obstructed                                                                                                                                                 See Chemotherapy for
                                                                                                                              or
                                     or imminent                                                                                                                                                Advanced or Metastatic
                                                                                                                              Bypass of impending
                                     obstruction                                                                                                                                                Disease (COL-C)
                                                                                                                              obstruction
                                                                                                                              or
                                                                                                                              Stenting




e 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
Guidelines Index

NCCN
                              ®
                                     Practice Guidelines                                                                                                                                           Colon Cancer Table of Contents
                                     in Oncology – v.1.2010                                  Colon Cancer                                                                                          Staging, Discussion, References


RECURRENCE                        WORKUP




                                                                                                                                                                 Negative
                                                                                                     · Consider PET-CT scan                                      findings
                                                                           Negative                  · Reevaluate chest/
                                  · Physical exam                          findings                    abdominal/pelvic CT
                                  · Colonoscopy                                                                                                                                                  See treatment for
Serial                                                                                                 in 3 mo                                                   Positive                        Documented
                                  · Chest/abdominal/
CEA                                                                                                                                                              findings                        metachronous
                                    pelvic CT
elevation                                                                                                                                                                                        metastases COL-10
                                  · Consider PET-CT                                                  See treatment for
                                    scan                                   Positive                  Documented
                                                                           findings                  metachronous
                                                                                                     metastases COL-10



Documented                                                  See treatment for
metachronous                                                Documented
metastases cc by CT,                                        metachronous
MRI and/or biopsy                                           metastases COL-10




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.
  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
Guidelines Index

NCCN
                              ®
                                     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-11



Documented
metachronous                                                                                                                                                                                                             Active
metastases cc,dd                                                                           FOLFIRI ±
                                                                                                                                                                                                                         chemotherapy
by CT, MRI                                                                                 bevacizumab
                                                                                                                                                                  Converted to                                           regimen ee
and/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
                                                     chemotherapy


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).
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
Guidelines Index

NCCN
                              ®
                                     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                             chemotherapy
Resectable e,dd             Consider                                                                                                                   Resection z                                                       Active
                                                                                                              (2-3 mo)                                                                                                   chemotherapy
metachronous                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
                                                                       chemotherapy

d 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 for
y 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
Guidelines Index

NCCN
                             ®
                                    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 Mutation
lymph 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.
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Colon

  • 1. NCCN Clinical Practice Guidelines in Oncology™ Colon Cancer V.1.2010 Continue www.nccn.org
  • 2. Guidelines Index NCCN ® 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 Women's 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 Children's 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References Table of Contents NCCN Colon Cancer Panel Members For help using these Summary of the Guidelines Updates documents, please click here Clinical 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 management Pathologic Stage, Adjuvant Therapy and Surveillance (COL-3) for any cancer patient is in a clinical Recurrence and Workup (COL-9) trial. Participation in clinical trials is Principles 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.html Principles of Risk Assessment for Stage II Disease (COL-D) NCCN Categories of Evidence and Principles of Adjuvant Therapy (COL-E) Consensus: All recommendations Principles of Radiation Therapy (COL-F) are Category 2A unless otherwise Principles of Survivorship (COL-G) specified. See NCCN Categories of Evidence and Consensus Guidelines Index Print 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References Summary of the Guidelines updates Summary 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References Summary of the Guidelines updates Summary 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References CLINICAL WORKUP FINDINGS SURGERY PRESENTATION a Single specimen, completely removed with · Pathology review b,c Observe favorable histological Pedunculated polyp · Colonoscopy features d and clear margins (adenoma [tubular, · Marking of See Pathologic tubulovillous, or cancerous polyp site Stage, Adjuvant villous]) with invasive Therapy, and (at time of Surveillance cancer 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 histological Sessile polyp · Colonoscopy bloc removal of features d and clear margins See Pathologic (adenoma [tubular, · Marking of regional lymph nodes Stage, Adjuvant tubulovillous, or cancerous polyp site Therapy, and villous]) with invasive (at time of Surveillance cancer 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 d 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. 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References CLINICAL WORKUP FINDINGS SURGERY PRESENTATION 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, Adjuvant Colon cancer regional lymph nodes Resectable, Therapy, and appropriate for chemistry profile, or Surveillance CEA obstructing Resection with diversion (COL-3) resection (non metastatic) · 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 or adenocarcinoma 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 Clinical g PET-CT does not supplant a contrast-enhanced diagnostic CT scan. Presentations h 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References PATHOLOGIC STAGE d ADJUVANT THERAPY i,k,l,m SURVEILLANCE r Tis; T1, N0, M0; · History and physical every 3-6 mo for 2 y, None T2, 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 lesions T3, 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 Recurrence T3, N0, M0 at high risk for preoperative colonoscopy due to systemic 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 y invasion, bowel obstruction, or > If no advanced adenoma, u repeat in 3 y, < 12 lymph nodes examined) Clinical trial or T4, N0, M0; or T3 with then every 5 y v or localized perforation or Observation n · PET-CT scan is not routinely close, indeterminate or recommended positive margins · See Principles of Survivorship (COL-G) Node positive disease, see page COL-4 a 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 considerably d 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. J j 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 or k 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 the m 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References PATHOLOGIC 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 See T1-3, N1-2, M0 · Colonoscopy a in 1 y except if no or Recurrence or 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. J d 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 or l 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 the o See Principles of Adjuvant Therapy (COL-E). US Multi-Society Task Force on Colorectal Cancer. Gastroenterology p 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References CLINICAL WORKUP FINDINGS PRESENTATION 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 Unresectable Suspected or · Determination of tumor KRAS gene See Treatment (potentially proven metastatic status (if KRAS non-mutated, and Adjuvant convertible e or synchronous consider BRAF testing) d Therapy (COL-7) unconvertible) adenocarcinoma · Needle biopsy, if clinically indicated from 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References TREATMENT ADJUVANT THERAPY SURVEILLANCE (resected metastatic disease) Resectable e synchronous liver (6 mo perioperative treatment preferred) and/or lung metastases only Colectomy, with synchronous or staged liver or lung If patient stage IV, NED: resection · CEA every 3 mo x 2 y, then every or Active chemotherapy regimen 6 mo x 3-5 y Neoadjuvant therapy (for 2-3 months) for advanced disease (See · Chest/abdominal/pelvic CT scan FOLFIRI 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 y wild-type gene only) d,y followed by synchronous or (category 2B) · Colonoscopy a in 1 y except if no Recurrence staged 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 mo FOLFIRI or FOLFOX or CapeOX w ± bevacizumab x or chemotherapy, if patient > If advanced adenoma, repeat FOLFIRI or FOLFOX or CapeOX w ± cetuximab (KRAS received neoadjuvant therapy in 1 y wild-type gene only) d,y and staged resection of > If no advanced adenoma, u metastatic disease repeat in 3 y, then every 5 y v 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. 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References TREATMENT ADJUVANT THERAPY SURVEILLANCE (6 mo perioperative Unresectable 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References FINDINGS PRIMARY TREATMENT See Chemotherapy for Nonobstructing Advanced or Metastatic Disease (COL-C) Synchronous abdominal/ peritoneal Colon resection e metastases bb or Diverting colostomy Obstructed See Chemotherapy for or or imminent Advanced or Metastatic Bypass of impending obstruction Disease (COL-C) obstruction or Stenting e 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. Guidelines Index NCCN ® Practice Guidelines Colon Cancer Table of Contents in Oncology – v.1.2010 Colon Cancer Staging, Discussion, References RECURRENCE WORKUP Negative · Consider PET-CT scan findings Negative · Reevaluate chest/ · Physical exam findings abdominal/pelvic CT · Colonoscopy See treatment for Serial in 3 mo Positive Documented · Chest/abdominal/ CEA findings metachronous pelvic CT elevation metastases COL-10 · Consider PET-CT See treatment for scan Positive Documented findings metachronous metastases COL-10 Documented See treatment for metachronous Documented metastases cc by CT, metachronous MRI and/or biopsy metastases COL-10 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. 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. Guidelines Index NCCN ® 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-11 Documented metachronous Active metastases cc,dd FOLFIRI ± chemotherapy by CT, MRI bevacizumab Converted to regimen ee and/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 chemotherapy 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). 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. Guidelines Index NCCN ® 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 chemotherapy Resectable e,dd Consider Resection z Active (2-3 mo) chemotherapy metachronous 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 chemotherapy d 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 for y 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. Guidelines Index NCCN ® 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 Mutation lymph 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