FOLLOW-UP CARE, SURVEILLANCE PROTOCOL, AND SECONDARY PREVENTION MEASURES FOR SURVIVORS OF COLORECTAL CANCER Clinical Practice Guideline Endorsement © American Society of Clinical Oncology®. All rights reserved.

Introduction The Cancer Care Ontario (CCO) Guideline on Follow-up Care, Surveillance Protocol, and Secondary Prevention Measures for Survivors of Colorectal Cancer (CRC) was reviewed by ASCO for methodologic rigor and considered for endorsement in ASCO Guideline endorsement procedures were approved in 2006 by the ASCO Board of Directors in order to increase number of high- quality, ASCO-vetted guidelines available, in lieu of undertaking its own guideline (de novo or Update) on a topic. © American Society of Clinical Oncology®. All rights reserved.

ASCO Endorsement Process Identify guideline for endorsement (Clinical Practice Guideline Committee [CPGC]) Conduct methodologic review by CPGC Methodology Subcommittee Member and/or ASCO Guidelines staff Use Rigour of Development subscale of the AGREE II instrument ( Conduct literature review to identify relevant literature published since completion of guideline under consideration Complete content review by an ASCO Expert Panel Use Guideline Endorsement Content Review Form Final approval of ASCO Clinical Practice Guideline Endorsement by CPGC © American Society of Clinical Oncology®. All rights reserved.

Cancer Care Ontario (CCO) Guideline Methodology: Systematic Review Developed under auspices of CCO Program in Evidence-Based Care (PEBC) for adults who completed primary treatment for stage II or III for CRC and without evidence of disease Literature search: 2000-June 2012 MEDLINE, EMBASE, and Cochrane Database of Systematic Reviews, Internet for guidelines relevant to the research questions ASCO Panel updated search: June 2012-March 2013 CCO identified 11 clinical practice guidelines on CRC follow-up Consensus of CCO Working Group - all 11 were of sufficient quality to inform recommendations © American Society of Clinical Oncology®. All rights reserved.

CCO Clinical Questions The CCO guideline addresses five clinical questions that are addressed in this ASCO Endorsement and one question (No. 6, omitted) that was specific to Ontario, Canada.* 1.Which evaluations (eg, colonoscopy, computed tomography [CT], carcinoembryonic antigen [CEA], liver function, complete blood count [CBC], chest x-ray, history, and physical examination) should be performed for surveillance for recurrence of cancer? 2.What is a reasonable frequency of these evaluations for surveillance? 3.Which symptoms and/or signs potentially signify a recurrence of CRC and warrant investigation? 4.What are the common and/or significant long-term and late effects of CRC treatment? 5.On what secondary prevention measures should CRC survivors be counseled? *Section reprinted with permission. © Cancer Care Ontario. All rights reserved. © American Society of Clinical Oncology®. All rights reserved.

The Bottom Line Intervention: Follow-up, surveillance, and secondary prevention measures for survivors of CRC, stages II and III (not stage I or resected metastatic disease, both of which have minimal data to provide guidance) Target Audience: Medical, surgical, and radiation oncologists, primary care providers, and others involved in the delivery of care for CRC survivors Patients and family members of patients who have survived CRC Methods: The ASCO Panel reviewed methodology employed in the guideline on CRC follow-up, considered results from the AGREE II review instrument, and considered the guideline content to determine appropriateness for endorsement. A literature search was conducted to evaluate new articles published since the CCO search; results were reviewed by the ASCO Panel. © American Society of Clinical Oncology®. All rights reserved.

ASCO Key Recommendations Surveillance should be guided by presumed risk of recurrence and functional status of patient where early detection would lead to aggressive treatment including surgery. It is especially important in the first 2 to 4 years, when the risk of recurrence is the greatest. A medical history, physical examination, and CEA testing should be performed every 3 to 6 months for 5 years. The frequency of visits and testing should be driven by the data showing that 80% of recurrences occur in the first 2 to 2.5 years from date of surgery and 95% occur by 5 years. Patients at a higher risk of recurrence should be considered for testing in the more frequent end of the range. Abdominal and chest imaging using a CT scan is recommended annually for 3 years. For high-risk patients, it is reasonable to consider imaging every 6 to 12 months for the first 3 years. Outside of a clinical trial, PET scans are not recommended for surveillance. © American Society of Clinical Oncology®. All rights reserved.

ASCO Key Recommendations For patients with rectal cancer, a pelvic CT is also recommended. Clinician judgment, considering risk status, should be used to determine the frequency of pelvic scans (eg, annually for 3 to 5 years). For those patients who have not received pelvic radiation, a rectosigmoidoscopy should be performed every 6 months for 2 to 5 years. A surveillance colonoscopy should be performed approximately 1 year after the initial surgery. The frequency of subsequent surveillance colonoscopies should be dictated by the findings of the previous one, but they generally should be performed every 5 years if the findings of the previous one are normal. If a complete colonoscopy was not performed before diagnosis, a colonoscopy should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point. Any new and persistent or worsening symptoms warrant the consideration of a recurrence. © American Society of Clinical Oncology®. All rights reserved.

ASCO Key Recommendations Despite the lack of high-quality evidence on secondary prevention in CRC survivors, it is reasonable to counsel patients on maintaining a healthy body weight, being physically active, and eating a healthy diet. A treatment plan from the specialist should be sent to the patient’s other providers, particularly the primary care physician, and it should have clear directions on appropriate follow-up. If a patient is not a surgical candidate or a candidate for systemic therapy because of severe comorbid conditions, surveillance tests should not be performed. © American Society of Clinical Oncology®. All rights reserved.

ASCO Discussion Section The ASCO Panel added minor qualifying statements to the CCO Guideline addressing: Evaluations and Intervals: Medical Examination and CEA Testing Imaging Rectal Cancer Colonoscopy Overuse and Underuse of Follow-up Testing Communication with Patient’s Other Providers Secondary Prevention of CRC © American Society of Clinical Oncology®. All rights reserved.

Endorsement Recommendation The ASCO Panel and the CPGC have reviewed the CCO Guideline on Follow-up Care, Surveillance Protocol, and Secondary Prevention Measures for Survivors of Colorectal Cancer and endorse the adoption of this guideline, with the minor qualifying statements listed in the Guideline Endorsement. A link to the CCO Guideline can be found at Or on the CCO website at leID= leID= © American Society of Clinical Oncology®. All rights reserved.

ASCO Panel Members PANEL MEMBERAFFILIATION Al B. Benson III, Co-Chair Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL Jeffrey A. Meyerhardt, Co-Chair Dana-Farber Institute, Boston, MA Patrick J. Flynn Minnesota Oncology, Minneapolis, MN Larissa Korde University of Washington, Seattle, WA Charles L. Loprinzi Mayo Clinic, Rochester, MN Bruce D. Minsky MD Anderson Cancer Center, Houston, TX Nicholas J. Petrelli Helen Graham Cancer Center, Newark, DE Kim Ryan Fight Colorectal Cancer, Alexandria, VA Deborah H. Schrag Dana-Farber Cancer Institute, Boston, MA Sandra L. Wong University of Michigan Medical School, Ann Arbor, MI Sandra L. Wong University of Michigan Medical School, Ann Arbor, MI © American Society of Clinical Oncology®. All rights reserved.

Disclaimer The clinical practice guidelines and other guidance published herein are provided by the American Society of Clinical Oncology, Inc. ("ASCO") to assist practitioners in clinical decision making. The information therein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients. Recommendations reflect high, moderate or low confidence that the recommendation reflects the net effect of a given course of action. [Cont’d on next slide] © American Society of Clinical Oncology®. All rights reserved.

Disclaimer The use of words like "must," "must not," "should," and "should not" indicate that a course of action is recommended or not recommended for either most or many patients, but there is latitude for the treating physician to select other courses of action in individual cases. In all cases, the selected course of action should be considered by the treating physician in the context of treating the individual patient. Use of the information is voluntary. ASCO provides this information on an "as is" basis, and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions. © American Society of Clinical Oncology®. All rights reserved.