VOLUME 31 䡠 NUMBER 35 䡠 DECEMBER 10 2013
JOURNAL OF CLINICAL ONCOLOGY
A S C O
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A R T I C L E
Follow-Up Care, Surveillance Protocol, and Secondary Prevention Measures for Survivors of Colorectal Cancer: American Society of Clinical Oncology Clinical Practice Guideline Endorsement Jeffrey A. Meyerhardt, Pamela B. Mangu, Patrick J. Flynn, Larissa Korde, Charles L. Loprinzi, Bruce D. Minsky, Nicholas J. Petrelli, Kim Ryan, Deborah H. Schrag, Sandra L. Wong, and Al B. Benson III Jeffrey A. Meyerhardt and Deborah H. Schrag, Dana-Farber Cancer Institute, Boston, MA; Pamela B. Mangu, American Society of Clinical Oncology; Kim Ryan, Fight Colorectal Cancer, Alexandria, VA; Patrick J. Flynn, Minnesota Oncology, Minneapolis; Charles L. Loprinzi, Mayo Clinic, Rochester, MN; Larissa Korde, University of Washington, Seattle, WA; Bruce D. Minsky, MD Anderson Cancer Center, Houston, TX; Nicholas J. Petrelli, Helen Graham Cancer Center, Newark, DE; Sandra L. Wong, University of Michigan Medical School, Ann Arbor, MI; and Al B. Benson III, Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL. Published online ahead of print at www.jco.org on November 12, 2013. ASCO Clinical Practice Guidelines Committee approval: April 26, 2013. Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article. Corresponding author: American Society of Clinical Oncology, 2318 Mill Rd, Suite 800, Alexandria, VA 22314; e-mail: [email protected]. © 2013 by American Society of Clinical Oncology
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Purpose The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing recent clinical practice guidelines that have been developed by other professional organizations. Methods The Cancer Care Ontario (CCO) Guideline on Follow-up Care, Surveillance Protocol, and Secondary Prevention Measures for Survivors of Colorectal Cancer was reviewed by ASCO for methodologic rigor and considered for endorsement. Results The ASCO Panel concurred with the CCO recommendations and recommended endorsement, with the addition of several qualifying statements. Conclusion Surveillance should be guided by presumed risk of recurrence and functional status of the patient (important within the first 2 to 4 years). Medical history, physical examination, and carcinoembryonic antigen testing should be performed every 3 to 6 months for 5 years. Patients at higher risk of recurrence should be considered for testing in the more frequent end of the range. A computed tomography scan (abdominal and chest) is recommended annually for 3 years, in most cases. Positron emission tomography scans should not be used for surveillance outside of a clinical trial. A surveillance colonoscopy should be performed 1 year after the initial surgery and then every 5 years, dictated by the findings of the previous one. If a colonoscopy was not preformed before diagnosis, it should be done after completion of adjuvant therapy (before 1 year). Secondary prevention (maintaining a healthy body weight and active lifestyle) is recommended. If a patient is not a candidate for surgery or systemic therapy because of severe comorbid conditions, surveillance tests should not be performed. A treatment plan from the specialist should have clear directions on appropriate follow-up by a nonspecialist. J Clin Oncol 31:4465-4470. © 2013 by American Society of Clinical Oncology
0732-183X/13/3135w-4465w/$20.00 DOI: 10.1200/JCO.2013.50.7442
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INTRODUCTION
In 2006, the American Society of Clinical Oncology (ASCO) Board of Directors approved a policy and a set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations. The goal of the endorsement policy is to increase the number of high-quality, ASCO-vetted guidelines available to the ASCO membership. Endorsement of guidelines will be considered in selected circumstances, either on request from related professional organizations at the discretion of the ASCO Clinical Practice Guidelines Committee (CPGC) or when ASCO seeks to endorse the guideline of another organization in lieu of
undertaking its own guideline on the same topic. Of note, guidelines considered for endorsement by ASCO are typically developed from established guideline development groups and are based on systematic reviews of the literature.
OVERVIEW OF THE ASCO GUIDELINE ENDORSEMENT PROCESS
The guideline under endorsement consideration is reviewed and approved by the ASCO CPGC. The CPGC review includes two parts: methodologic review and content review. The content review is completed by an ASCO Panel (Appendix Table A1, © 2013 by American Society of Clinical Oncology
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online only). The methodologic review is completed by a member of the CPGC Methodology Subcommittee and/or by ASCO guideline staff using the Rigour of Development subscale of the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument (www.agreetrust.org). The Rigour subscale consists of seven items that assess the quality of the processes used to gather and synthesize the relevant data and the methods used to formulate the guideline recom-
mendations (Appendix Table A2, online only). In addition to this methodologic review, ASCO staff conducts literature searches to identify relevant studies and additional systematic reviews, meta-analyses, and guidelines that have been published since the guideline under endorsement was completed. The content review is completed by an ASCO Panel. The Panel members are asked to complete an eight-item Guideline Endorsement
THE BOTTOM LINE ASCO endorses the CCO Practice Guideline on Follow-up Care, Surveillance Protocol, and Secondary Prevention Measures for Survivors of CRC, with qualifying statements 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 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. ● 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. ● 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. 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 ad hoc Panel. A link1 to the CCO guideline can be found at http://www.asco.org/endorsements/CRC/FU or on the CCO Web site at https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileIdⴝ124839.
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Content Review Form (Appendix Table A3, online only) that assesses the perceived clarity and clinical utility of the recommendations and the degree to which the recommendations are consistent with the content reviewers’ interpretation of the available data on the topic in question. This form was adapted by ASCO from the Cancer Care Ontario (CCO) Program in Evidence-Based Care (PEBC) Practitioner Feedback instrument. Final review and approval are competed by the ASCO CPGC after approval by the ASCO Panel. Disclaimer The information contained herein, including but not limited to clinical practice guidelines and other guidance, is based on the best available evidence at the time of creation and is provided by ASCO to assist providers in clinical decision making. The information should not be relied on 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 address 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 product or course of medical treatment. Furthermore, the information is not intended to substitute for the independent professional judgment of the treating provider, because 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. 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 certain cases. In all cases, the selected course of action should be considered by the treating provider 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. Guidelines and Conflicts of Interest The ASCO Panel was assembled in accordance with ASCO Conflicts of Interest Management Procedures for Clinical Practice Guidelines (ASCO procedures are summarized at http://www.asco.org/ rwc). Members of the Panel completed the ASCO disclosure form, which requires disclosure of financial and other interests that are relevant to the subject matter of the guideline, including relationships with commercial entities that are reasonably likely to experience direct regulatory or commercial impact as the result of promulgation of the guideline. Categories for disclosure include employment relationships, consulting arrangements, stock ownership, honoraria, research funding, and expert testimony. In accordance with the procedures, the majority of the members of the ASCO Panel did not disclose any such relationships. www.jco.org
CCO PRACTICE GUIDELINE ON FOLLOW-UP CARE, SURVEILLANCE PROTOCOL, AND SECONDARY PREVENTION MEAUSRES FOR SURVIVIORS OF COLORECTAL CANCER
CCO Guideline Clinical Questions, Target Population, and Intended Users The CCO guideline1 addresses five clinical questions that are addressed in this ASCO Endorsement and one question (No. 6) 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? 6. Are there preferred models of follow-up care in Ontario, ie, should patient follow-up be done by a medical oncologist, radiation oncologist, surgeon, advanced practice nurse, physician assistant, or primary care provider (eg, family physician, nurse practitioner, family practice nurse)? (for Ontario, Canada; not applicable for ASCO) The target population included CRC survivors (adult patients who have completed primary treatment for stage II or III CRC and who are without evidence of disease). Whether these recommendations are extrapolated to stage I patients (ASCO note: or a patient with metastatic CRC who underwent metastatectomy and is currently without evidence of disease, because there are few to no data for surveillance in these groups) is left to the discretion of the health care provider. Intended users are: 1. Clinicians (eg, medical oncologist, radiation oncologist, surgeon, advanced practice nurse, physician assistant, primary care provider [family physician, nurse practitioner, family practice nurse]) involved in the delivery of care for CRC survivors 2. Patients and families of patients who have survived CRC 3. Health care organizations and system leaders responsible for offering, monitoring, or providing resources for CRC survivorship protocols (Section reprinted with permission. © Cancer Care Ontario. All rights reserved.) SUMMARY OF CCO GUIDELINE DEVELOPMENT METHODOLOGY
The CCO guideline was developed under the auspices of the CCO PEBC by a guideline development group convened in partnership with CCO’s Survivorship Programs, including clinical experts and methodologists. The literature search included MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews and a search on the Internet for guidelines relevant to the research questions (using the PEBC preferred list of guideline developers and guideline directories © 2013 by American Society of Clinical Oncology
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of Canadian and international health organizations, including the National Guidelines Clearinghouse). The literature search spanned from 2000 to June 2012. The ASCO Panel conducted an updated search through March 2013 and found no additional guidelines relevant to the CCO research questions. To summarize, the CCO Guideline identified 11 clinical practice guidelines (Table 2 in CCO Guideline; ASCO Data Supplement 1) on follow-up protocols for CRC survivors to inform recommendations for their research questions No. 1 to 5. AGREE II evaluations were reported for the 11 included guidelines, and the scores for each of the evaluations across different domains are summarized in the CCO Guideline. The ASCO clinical authors confirmed that these guidelines are still valid and in use by clinicians. The recommendations from each of the identified guidelines are consistent across all the guidelines. The consensus of the CCO Colorectal Cancer Survivorship Working Group was that all the included guidelines were of sufficient quality to inform the development of Ontario-specific recommendations (Table 3 in CCO Guideline; ASCO Data Supplement 2). PEBC, ASCO, Cancer Council Australia, Australian Cancer Network, New Zealand Guidelines Group, and National Comprehensive Cancer Network practice guidelines were considered to be of higher quality or of greater relevance than those remaining.2-5,7-12 Links to the CCO search terms and quorum diagram are provided in Data Supplements 3 and 4, respectively, as are details of an updated ASCO search about positron emission tomography (PET) scans for surveillance. On the basis of the available evidence and expert opinion, the CCO Working Group made recommendations for adult patients who have completed primary treatment for stage II or III CRC and who are without evidence of disease. The conclusions of CCO Guideline are provided in Data Supplement 5. More detailed recommendations with key evidence and qualifying statements are found in the CCO Guideline.
searched from June 2012 to March 2013. The CCO inclusion criteria were applied to the review of the literature search results. The updated search yielded no new publications that satisfied the CCO inclusion criteria. RESULTS OF THE ASCO CONTENT REVIEW
The ASCO Panel reviewed the guideline in question and concurs that the recommendations are clear, thorough, and based on the most relevant scientific evidence in this content area and that they present options that will be acceptable to patients. Overall, the ASCO Panel agrees with the recommendations as stated in the CCO Guideline, with the qualification that ongoing research studies may alter the recommendations. Of note, the CCO Guideline does not include explicit recommendations for follow-up care, surveillance protocol, or secondary prevention measures for survivors of stage I CRC; recommendations for follow-up on chemotherapy-induced peripheral neuropathy; or targeted recommendation for patients with high-risk hereditary syndromes. Therefore, these issues are not addressed in the ASCO endorsement. DISCUSSION
The ASCO Panel wants to highlight that the CCO recommendations are primarily for patients with stage II or III cancer. There are insufficient data to provide guidance for follow-up for stage I patients or patients with resected metastatic disease with no evidence of disease. The ASCO Panel emphasizes that surveillance tests should only be performed in patients in whom the results will change treatment decisions. For example, 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.
METHODS AND RESULTS OF THE ASCO UPDATED LITERATURE SEARCH
Evaluations and Intervals: Medical Examination and CEA Testing The ASCO Panel added qualifying statements to the CCO recommendations based on its interpretation of the data presented in the CCO Systematic Review and Guideline. Surveillance should be guided by presumed risk of recurrence. This is especially important in the first 2 to 4 years, when the risk of recurrence is the greatest. For patients at higher risk of recurrence, providers may want to consider more frequent interval testing.13 Although the data are insufficient to make a definitive recommendation about the frequency of CEA testing, the ASCO Panel asserted that CEA may be checked between the range of 3 to 6 months in the first 2 years, because 80% of recurrences occur in the first 2 to 2.5 years in patients with a high risk of recurrence. The ASCO Panel noted that the end date for surveillance is particularly important given the very high conditional survival rates at 4 to 5 years out from treatment (curves start to flatten out at 3 years).13
A search for new evidence was conducted by ASCO guideline staff to identify relevant randomized controlled trials, systematic reviews, meta-analyses, and guidelines that have been published since the CCO Guideline was completed. Following the strategies described in the CCO Guideline, Medline and the Cochrane Library databases were
Imaging The ASCO Panel concurs that abdominal and chest imaging using a CT scan is recommended annually for 3 years, in most cases. But ASCO recommends that clinician judgment be used to determine the frequency of pelvic scans for high-risk patients (potentially every 6
RESULTS OF THE ASCO METHODOLOGIC REVIEW
The methodologic review of the CCO guideline was completed independently by two ASCO guideline staff members using the Rigour of Development subscale from the AGREE II instrument, as discussed. The score for the Rigour of Development domain is calculated by summing the scores across individual items in the domain and standardizing the total score as a proportion of the maximum possible score. Detailed results of the scoring for this guideline are available on request to [email protected]. Overall, the CCO guideline scored very high (85%) in terms of methodologic quality, with only minor deviations from the ideal as reflected in the AGREE II items.
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to 12 months). The ASCO Panel agrees that PET scans should not be used for surveillance outside of the setting of a clinical trial. An abstract presented at the ASCO 2013 Annual Meeting14 suggests that doing both CT scanning with CEA testing may not make a difference in overall mortality, although proper evaluation of how to apply results from this trial will require review of the full manuscript once published. Rectal Cancer If the primary tumor was in the rectum, pelvic CT scans are also recommended, and the ASCO Panel reiterates that clinician judgment should be used to determine the frequency of pelvic scans for these high-risk patients (every 6 to 12 months for 2 to 3 years, then annually until 5 years from surgery) based on risk. (One member of the ASCO Panel suggests 5 years of pelvic scans, if the primary tumor was located in the rectum [v just 3 years in the CCO Guideline]). The ASCO Panel wants to emphasize a footnote in Table 1 in the CCO Guideline that states that patients with rectal cancer who have not received pelvic radiation should receive a rectosigmoidoscopy every 6 months for 2 to 5 years. The Panel wants to clarify that colonoscopies should not necessarily be limited to those without radiation, because a T4 or N2 rectal cancer still has a reasonable local recurrence rate despite optimal total mesorectal excision surgery and radiation (pre- or postoperatively).15-17 Colonoscopy The ASCO Panel wants to add a clarification to the CCO recommendation about the timing of follow-up colonoscopies. If a complete colonoscopy was not performed before diagnosis, a colonoscopy should be done as soon as is reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point. Overuse and Underuse of Follow-Up Testing The ASCO Panel suggests that the clinician should consider rechecking CEA if the test result is going up or going up and down; in this case, rechecking is not overuse, because it is not surveillance but follow-up of abnormal results and appropriate use to test more frequently (Table 5 in CCO Guideline; ASCO Data Supplement 2). The ASCO Panel also emphasizes that overuse must be considered differently for high-risk versus low-risk patients, so it is better to have some flexibility in following these patients. Additional testing should not always be considered overuse.
or institution-based nurse-coordinated care. The Panel wants to emphasize the need to provide the patient and the patient’s other providers, including the primary care physician, a treatment summary as well as guidance on surveillance schedule. Secondary Prevention of CRC There are emerging data on the role of various host factors, including diet and lifestyle, as secondary prevention for CRC survivors.18,19 While such data are based on prospective, observational studies and lack confirmation from randomized clinical trials to date, the Panel agrees with the CCO Guideline for secondary prevention in CRC survivors. Patients should seek to maintain a healthy body weight. Survivors should engage in a physically active lifestyle, seeking to follow the recommendation of the American College of Sports Medicine to strive to engage in at least 150 minutes a week of moderate-intensity, or 75 minutes (1 hour and 15 minutes) a week of vigorous-intensity aerobic physical activity, or an equivalent combination of moderate- and vigorous-intensity aerobic activity.20 However, any level of activity that the patient can do is considered better than being physically inactive. Survivors should be advised to eat a healthy diet. There remains uncertainty regarding regular use of an aspirin21,22 or cyclooxygenase inhibitor and in which survivors; however, an ongoing randomized clinical trial (CALGB [Cancer and Leukemia Group B] 80702) is being conducted by the National Cancer Institute cooperative groups on whether celecoxib will improve outcomes in CRC survivors.23 Other interventions, including vitamin D, also require further study to help provide guidance for secondary prevention. ENDORSEMENT RECOMMENDATION
The ASCO Panel and the CPGC have reviewed the CCO Guideline and endorse the adoption of this guideline, with the minor qualifying statements above. AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest.
AUTHOR CONTRIBUTIONS
Communication With Patient’s Other Providers Emerging evidence suggests that it is a reasonable option for CRC survivors who have completed all treatment to be discharged from specialist-led care to community-based family physician– coordinated REFERENCES 1. Earle C, Annis R, Sussman J, et al: Follow-up care, surveillance protocol, and secondary prevention measures for survivors of colorectal cancer. https:// www.cancercare.on.ca/common/pages/UserFile .aspx?fileId⫽124839 2. Cairns SR, Scholefield JH, Steele RJ, et al: Guidelines for colorectal cancer screening and surveillance in moderate and high risk groups (update from 2002). Gut 59:666-689, 2010 www.jco.org
Administrative support: Pamela B. Mangu Manuscript writing: All authors Final approval of manuscript: All authors
3. Glimelius B, Påhlman L, Cervantes A: Rectal cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 21:v82v86, 2010 (suppl 5) 4. Labianca R, Nordlinger B, Beretta GD, et al: Primary colon cancer: ESMO clinical practice guidelines for diagnosis, adjuvant treatment and followup. Ann Oncol 21:v70-v77, 2010 (suppl 5) 5. National Comprehensive Cancer Network: NCCN guidelines. http://www.nccn.org/professionals/ physician_gls/f_guidelines.asp 6. Reference deleted
7. Cancer Care Ontario: Follow-up of patients with curatively resected colorectal cancer. https://www.cancercare.on.ca/common/pages/ UserFile.aspx?fileId⫽14014 8. Rex DK, Kahi CJ, Levin B, et al: Guidelines for colonoscopy surveillance after cancer resection: A consensus update by the American Cancer Society and US Multi-Society Task Force on Colorectal Cancer. CA Cancer J Clin 56:160-167, 2006; quiz 185-186 9. Desch CE, Benson AB 3rd, Somerfield MR, et al: Colorectal cancer surveillance: 2005 update of an
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American Society of Clinical Oncology practice guideline. J Clin Oncol 23:8512-8519, 2005 10. Australian Cancer Network: Clinical practice guidelines for the prevention, early detection and management of colorectal cancer. http://www.nhmrc.gov.au/ publications/synopses/cp106/cp106syn.htm 11. Anthony T, Simmang C, Hyman N, et al: Practice parameters for the surveillance and follow-up of patients with colon and rectal cancer. Dis Colon Rectum 47:807-817, 2004 12. New Zealand Guidelines Group: Guidance on surveillance for people at increased risk of colorectal cancer. http://www.health.govt.nz/publication/guidancesurveillance-people-increased-risk-colorectal-cancer 13. Sargent DJ, Patiyil S, Yothers G, et al: End points for colon cancer adjuvant trials: Observations and recommendations based on individual patient data from 20,898 patients enrolled onto 18 randomized trials from the ACCENT Group. J Clin Oncol 25:4569-4574, 2007
14. Mant D, Perera R, Gray A, et al: Effect of 3-5 years of scheduled CEA and CT follow-up to detect recurrence of colorectal cancer: FACS randomized controlled trial. J Clin Oncol 31, 2013 (suppl; abstr 3500) 15. Gunderson LL, Jessup JM, Sargent DJ, et al: Revised TN categorization for colon cancer based on national survival outcomes data. J Clin Oncol 28: 264-271, 2010 16. Baxter NN, Hartman LK, Tepper JE, et al: Postoperative irradiation for rectal cancer increases the risk of small bowel obstruction after surgery. Ann Surg 245:553-559, 2007 17. Quirke P, Morris E: Reporting colorectal cancer. Histopathology 50:103-112, 2007 18. Meyerhardt JA, Ma J, Courneya KS: Energetics in colorectal and prostate cancer. J Clin Oncol 28:4066-4073, 2010 19. Rock CL, Doyle C, Demark-Wahnefried W, et al: Nutrition and physical activity guidelines for
cancer survivors. CA Cancer J Clin 62:243-274, 2012 20. Schmitz KH, Courneya KS, Matthews C, et al: American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc 42:1409-1426, 2010 21. Sandler RS, Halabi S, Baron JA, et al: A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer. N Engl J Med 348:883-890, 2003 22. National Cancer Institute: Colorectal cancer prevention: Aspirin. http://www.cancer.gov/cancertopics/ pdq/prevention/colorectal/HealthProfessional/ page2#Section_964 23. Oxaliplatin, leucovorin calcium, and fluorouracil with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. http://clinicaltrials.gov/ct2/show/NCT01150045?term⫽ CALGB⫹80702&rank⫽1
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Acknowledgment The Panel wishes to thank Alok Khorana, MD, and Yousef Zafar, MD, and the full Clinical Practice Guidelines Committee for their thoughtful reviews of earlier drafts. Appendix
Table A1. Members of the ASCO Guideline Panel Panel Member
Institution
Al B. Benson III, Co-Chair Jeffrey A. Meyerhardt, Co-Chair Patrick J. Flynn Larissa Korde Charles L. Loprinzi Bruce D. Minsky Nicholas J. Petrelli Kim Ryan Deborah H. Schrag Sandra L. Wong
Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL Dana-Farber Institute, Boston, MA Minnesota Oncology, Minneapolis, MN University of Washington, Seattle, WA Mayo Clinic, Rochester, MN MD Anderson Cancer Center, Houston, TX Helen Graham Cancer Center, Newark, DE Fight Colorectal Cancer, Alexandria, VA Dana-Farber Cancer Institute, Boston, MA University of Michigan Medical School, Ann Arbor, MI
Abbreviation: ASCO, American Society of Clinical Oncology.
Table A2. Rigour of Development Subscale of the Appraisal of Guidelines for Research and Evaluation II Instrument Rigor of Development Subscale Item Systematic methods were used to search for evidence. The criteria for selecting the evidence are clearly described. The strengths and limitations of the body of evidence are clearly described. The methods used for formulating the recommendations are clearly described. The health benefits, side effects, and risks have been considered in formulating the recommendations. There is an explicit link between the recommendations and the supporting evidence. The guideline has been externally reviewed by experts prior to its publication. A procedure for updating the guideline is provided. NOTE. Each subscale item is rated on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). The score for the Rigour of Development domain is calculated by summing the scores across individual items in the domain and across all raters, subtracting the lowest possible score for that domain (1 ⫻ No. of items ⫻ No. of raters), then standardizing the total score as a proportion of the maximum possible score (7 ⫻ No. of items ⫻ No. of raters) minus the lowest possible score.
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Table A3. ASCO Guideline Endorsement Content Review Formⴱ Statement
Strongly Agree
Agree
Neither Agree or Disagree
Disagree
Strongly Disagree
Unsure
The results of the studies described in this guideline are interpreted according to my understanding of the data. The recommendations in this report are clear. I agree with the recommendations as stated in the guideline. The recommendations are suitable for the patients for whom they are intended. The recommendations are too rigid to apply to individual patients. When applied, the recommendations will produce more benefits for patients than harms. The guideline presents options that will be acceptable to patients. The guideline should be endorsed by ASCO.
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NOTE. This form was adapted from the Cancer Care Ontario Program in Evidence-Based Care Practitioner Feedback instrument. Abbreviation: ASCO, American Society of Clinical Oncology. ⴱ Background and instructions when filling in the form are given as follows: ASCO considers clinical practice guidelines developed by other professional organizations for endorsement. This is done by ASCO most often in lieu of undertaking its own guideline on the same topic. You have been asked to provide a content review of a guideline that is under consideration for endorsement by ASCO. Please check the box that best applies for each of the following items. Guideline title, organization, and reviewer name are also provided.
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Follow-Up Care, Surveillance Protocol, and Secondary Prevention Measures for Survivors of Colorectal Cancer: American Society of Clinical Oncology Clinical Practice Guideline Endorsement Jeffrey A. Meyerhardt, Pamela B. Mangu, Patrick J. Flynn, Larissa Korde, Charles L. Loprinzi, Bruce D. Minsky, Nicholas J. Petrelli, Kim Ryan, Deborah H. Schrag, Sandra L. Wong, and Al B. Benson III Jeffrey A. Meyerhardt and Deborah H. Schrag, Dana-Farber Cancer Institute, Boston, MA; Pamela B. Mangu, American Society of Clinical Oncology; Kim Ryan, Fight Colorectal Cancer, Alexandria, VA; Patrick J. Flynn, Minnesota Oncology, Minneapolis; Charles L. Loprinzi, Mayo Clinic, Rochester, MN; Larissa Korde, University of Washington, Seattle, WA; Bruce D. Minsky, MD Anderson Cancer Center, Houston, TX; Nicholas J. Petrelli, Helen Graham Cancer Center, Newark, DE; Sandra L. Wong, University of Michigan Medical School, Ann Arbor, MI; and Al B. Benson III, Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL. Published online ahead of print at www.jco.org on November 12, 2013. ASCO Clinical Practice Guidelines Committee approval: April 26, 2013. Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article. Corresponding author: American Society of Clinical Oncology, 2318 Mill Rd, Suite 800, Alexandria, VA 22314; e-mail: [email protected]. © 2013 by American Society of Clinical Oncology
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Purpose The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing recent clinical practice guidelines that have been developed by other professional organizations. Methods The Cancer Care Ontario (CCO) Guideline on Follow-up Care, Surveillance Protocol, and Secondary Prevention Measures for Survivors of Colorectal Cancer was reviewed by ASCO for methodologic rigor and considered for endorsement. Results The ASCO Panel concurred with the CCO recommendations and recommended endorsement, with the addition of several qualifying statements. Conclusion Surveillance should be guided by presumed risk of recurrence and functional status of the patient (important within the first 2 to 4 years). Medical history, physical examination, and carcinoembryonic antigen testing should be performed every 3 to 6 months for 5 years. Patients at higher risk of recurrence should be considered for testing in the more frequent end of the range. A computed tomography scan (abdominal and chest) is recommended annually for 3 years, in most cases. Positron emission tomography scans should not be used for surveillance outside of a clinical trial. A surveillance colonoscopy should be performed 1 year after the initial surgery and then every 5 years, dictated by the findings of the previous one. If a colonoscopy was not preformed before diagnosis, it should be done after completion of adjuvant therapy (before 1 year). Secondary prevention (maintaining a healthy body weight and active lifestyle) is recommended. If a patient is not a candidate for surgery or systemic therapy because of severe comorbid conditions, surveillance tests should not be performed. A treatment plan from the specialist should have clear directions on appropriate follow-up by a nonspecialist. J Clin Oncol 31:4465-4470. © 2013 by American Society of Clinical Oncology
0732-183X/13/3135w-4465w/$20.00 DOI: 10.1200/JCO.2013.50.7442
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INTRODUCTION
In 2006, the American Society of Clinical Oncology (ASCO) Board of Directors approved a policy and a set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations. The goal of the endorsement policy is to increase the number of high-quality, ASCO-vetted guidelines available to the ASCO membership. Endorsement of guidelines will be considered in selected circumstances, either on request from related professional organizations at the discretion of the ASCO Clinical Practice Guidelines Committee (CPGC) or when ASCO seeks to endorse the guideline of another organization in lieu of
undertaking its own guideline on the same topic. Of note, guidelines considered for endorsement by ASCO are typically developed from established guideline development groups and are based on systematic reviews of the literature.
OVERVIEW OF THE ASCO GUIDELINE ENDORSEMENT PROCESS
The guideline under endorsement consideration is reviewed and approved by the ASCO CPGC. The CPGC review includes two parts: methodologic review and content review. The content review is completed by an ASCO Panel (Appendix Table A1, © 2013 by American Society of Clinical Oncology
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online only). The methodologic review is completed by a member of the CPGC Methodology Subcommittee and/or by ASCO guideline staff using the Rigour of Development subscale of the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument (www.agreetrust.org). The Rigour subscale consists of seven items that assess the quality of the processes used to gather and synthesize the relevant data and the methods used to formulate the guideline recom-
mendations (Appendix Table A2, online only). In addition to this methodologic review, ASCO staff conducts literature searches to identify relevant studies and additional systematic reviews, meta-analyses, and guidelines that have been published since the guideline under endorsement was completed. The content review is completed by an ASCO Panel. The Panel members are asked to complete an eight-item Guideline Endorsement
THE BOTTOM LINE ASCO endorses the CCO Practice Guideline on Follow-up Care, Surveillance Protocol, and Secondary Prevention Measures for Survivors of CRC, with qualifying statements 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 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. ● 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. ● 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. 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 ad hoc Panel. A link1 to the CCO guideline can be found at http://www.asco.org/endorsements/CRC/FU or on the CCO Web site at https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileIdⴝ124839.
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Content Review Form (Appendix Table A3, online only) that assesses the perceived clarity and clinical utility of the recommendations and the degree to which the recommendations are consistent with the content reviewers’ interpretation of the available data on the topic in question. This form was adapted by ASCO from the Cancer Care Ontario (CCO) Program in Evidence-Based Care (PEBC) Practitioner Feedback instrument. Final review and approval are competed by the ASCO CPGC after approval by the ASCO Panel. Disclaimer The information contained herein, including but not limited to clinical practice guidelines and other guidance, is based on the best available evidence at the time of creation and is provided by ASCO to assist providers in clinical decision making. The information should not be relied on 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 address 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 product or course of medical treatment. Furthermore, the information is not intended to substitute for the independent professional judgment of the treating provider, because 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. 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 certain cases. In all cases, the selected course of action should be considered by the treating provider 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. Guidelines and Conflicts of Interest The ASCO Panel was assembled in accordance with ASCO Conflicts of Interest Management Procedures for Clinical Practice Guidelines (ASCO procedures are summarized at http://www.asco.org/ rwc). Members of the Panel completed the ASCO disclosure form, which requires disclosure of financial and other interests that are relevant to the subject matter of the guideline, including relationships with commercial entities that are reasonably likely to experience direct regulatory or commercial impact as the result of promulgation of the guideline. Categories for disclosure include employment relationships, consulting arrangements, stock ownership, honoraria, research funding, and expert testimony. In accordance with the procedures, the majority of the members of the ASCO Panel did not disclose any such relationships. www.jco.org
CCO PRACTICE GUIDELINE ON FOLLOW-UP CARE, SURVEILLANCE PROTOCOL, AND SECONDARY PREVENTION MEAUSRES FOR SURVIVIORS OF COLORECTAL CANCER
CCO Guideline Clinical Questions, Target Population, and Intended Users The CCO guideline1 addresses five clinical questions that are addressed in this ASCO Endorsement and one question (No. 6) 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? 6. Are there preferred models of follow-up care in Ontario, ie, should patient follow-up be done by a medical oncologist, radiation oncologist, surgeon, advanced practice nurse, physician assistant, or primary care provider (eg, family physician, nurse practitioner, family practice nurse)? (for Ontario, Canada; not applicable for ASCO) The target population included CRC survivors (adult patients who have completed primary treatment for stage II or III CRC and who are without evidence of disease). Whether these recommendations are extrapolated to stage I patients (ASCO note: or a patient with metastatic CRC who underwent metastatectomy and is currently without evidence of disease, because there are few to no data for surveillance in these groups) is left to the discretion of the health care provider. Intended users are: 1. Clinicians (eg, medical oncologist, radiation oncologist, surgeon, advanced practice nurse, physician assistant, primary care provider [family physician, nurse practitioner, family practice nurse]) involved in the delivery of care for CRC survivors 2. Patients and families of patients who have survived CRC 3. Health care organizations and system leaders responsible for offering, monitoring, or providing resources for CRC survivorship protocols (Section reprinted with permission. © Cancer Care Ontario. All rights reserved.) SUMMARY OF CCO GUIDELINE DEVELOPMENT METHODOLOGY
The CCO guideline was developed under the auspices of the CCO PEBC by a guideline development group convened in partnership with CCO’s Survivorship Programs, including clinical experts and methodologists. The literature search included MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews and a search on the Internet for guidelines relevant to the research questions (using the PEBC preferred list of guideline developers and guideline directories © 2013 by American Society of Clinical Oncology
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of Canadian and international health organizations, including the National Guidelines Clearinghouse). The literature search spanned from 2000 to June 2012. The ASCO Panel conducted an updated search through March 2013 and found no additional guidelines relevant to the CCO research questions. To summarize, the CCO Guideline identified 11 clinical practice guidelines (Table 2 in CCO Guideline; ASCO Data Supplement 1) on follow-up protocols for CRC survivors to inform recommendations for their research questions No. 1 to 5. AGREE II evaluations were reported for the 11 included guidelines, and the scores for each of the evaluations across different domains are summarized in the CCO Guideline. The ASCO clinical authors confirmed that these guidelines are still valid and in use by clinicians. The recommendations from each of the identified guidelines are consistent across all the guidelines. The consensus of the CCO Colorectal Cancer Survivorship Working Group was that all the included guidelines were of sufficient quality to inform the development of Ontario-specific recommendations (Table 3 in CCO Guideline; ASCO Data Supplement 2). PEBC, ASCO, Cancer Council Australia, Australian Cancer Network, New Zealand Guidelines Group, and National Comprehensive Cancer Network practice guidelines were considered to be of higher quality or of greater relevance than those remaining.2-5,7-12 Links to the CCO search terms and quorum diagram are provided in Data Supplements 3 and 4, respectively, as are details of an updated ASCO search about positron emission tomography (PET) scans for surveillance. On the basis of the available evidence and expert opinion, the CCO Working Group made recommendations for adult patients who have completed primary treatment for stage II or III CRC and who are without evidence of disease. The conclusions of CCO Guideline are provided in Data Supplement 5. More detailed recommendations with key evidence and qualifying statements are found in the CCO Guideline.
searched from June 2012 to March 2013. The CCO inclusion criteria were applied to the review of the literature search results. The updated search yielded no new publications that satisfied the CCO inclusion criteria. RESULTS OF THE ASCO CONTENT REVIEW
The ASCO Panel reviewed the guideline in question and concurs that the recommendations are clear, thorough, and based on the most relevant scientific evidence in this content area and that they present options that will be acceptable to patients. Overall, the ASCO Panel agrees with the recommendations as stated in the CCO Guideline, with the qualification that ongoing research studies may alter the recommendations. Of note, the CCO Guideline does not include explicit recommendations for follow-up care, surveillance protocol, or secondary prevention measures for survivors of stage I CRC; recommendations for follow-up on chemotherapy-induced peripheral neuropathy; or targeted recommendation for patients with high-risk hereditary syndromes. Therefore, these issues are not addressed in the ASCO endorsement. DISCUSSION
The ASCO Panel wants to highlight that the CCO recommendations are primarily for patients with stage II or III cancer. There are insufficient data to provide guidance for follow-up for stage I patients or patients with resected metastatic disease with no evidence of disease. The ASCO Panel emphasizes that surveillance tests should only be performed in patients in whom the results will change treatment decisions. For example, 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.
METHODS AND RESULTS OF THE ASCO UPDATED LITERATURE SEARCH
Evaluations and Intervals: Medical Examination and CEA Testing The ASCO Panel added qualifying statements to the CCO recommendations based on its interpretation of the data presented in the CCO Systematic Review and Guideline. Surveillance should be guided by presumed risk of recurrence. This is especially important in the first 2 to 4 years, when the risk of recurrence is the greatest. For patients at higher risk of recurrence, providers may want to consider more frequent interval testing.13 Although the data are insufficient to make a definitive recommendation about the frequency of CEA testing, the ASCO Panel asserted that CEA may be checked between the range of 3 to 6 months in the first 2 years, because 80% of recurrences occur in the first 2 to 2.5 years in patients with a high risk of recurrence. The ASCO Panel noted that the end date for surveillance is particularly important given the very high conditional survival rates at 4 to 5 years out from treatment (curves start to flatten out at 3 years).13
A search for new evidence was conducted by ASCO guideline staff to identify relevant randomized controlled trials, systematic reviews, meta-analyses, and guidelines that have been published since the CCO Guideline was completed. Following the strategies described in the CCO Guideline, Medline and the Cochrane Library databases were
Imaging The ASCO Panel concurs that abdominal and chest imaging using a CT scan is recommended annually for 3 years, in most cases. But ASCO recommends that clinician judgment be used to determine the frequency of pelvic scans for high-risk patients (potentially every 6
RESULTS OF THE ASCO METHODOLOGIC REVIEW
The methodologic review of the CCO guideline was completed independently by two ASCO guideline staff members using the Rigour of Development subscale from the AGREE II instrument, as discussed. The score for the Rigour of Development domain is calculated by summing the scores across individual items in the domain and standardizing the total score as a proportion of the maximum possible score. Detailed results of the scoring for this guideline are available on request to [email protected]. Overall, the CCO guideline scored very high (85%) in terms of methodologic quality, with only minor deviations from the ideal as reflected in the AGREE II items.
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to 12 months). The ASCO Panel agrees that PET scans should not be used for surveillance outside of the setting of a clinical trial. An abstract presented at the ASCO 2013 Annual Meeting14 suggests that doing both CT scanning with CEA testing may not make a difference in overall mortality, although proper evaluation of how to apply results from this trial will require review of the full manuscript once published. Rectal Cancer If the primary tumor was in the rectum, pelvic CT scans are also recommended, and the ASCO Panel reiterates that clinician judgment should be used to determine the frequency of pelvic scans for these high-risk patients (every 6 to 12 months for 2 to 3 years, then annually until 5 years from surgery) based on risk. (One member of the ASCO Panel suggests 5 years of pelvic scans, if the primary tumor was located in the rectum [v just 3 years in the CCO Guideline]). The ASCO Panel wants to emphasize a footnote in Table 1 in the CCO Guideline that states that patients with rectal cancer who have not received pelvic radiation should receive a rectosigmoidoscopy every 6 months for 2 to 5 years. The Panel wants to clarify that colonoscopies should not necessarily be limited to those without radiation, because a T4 or N2 rectal cancer still has a reasonable local recurrence rate despite optimal total mesorectal excision surgery and radiation (pre- or postoperatively).15-17 Colonoscopy The ASCO Panel wants to add a clarification to the CCO recommendation about the timing of follow-up colonoscopies. If a complete colonoscopy was not performed before diagnosis, a colonoscopy should be done as soon as is reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point. Overuse and Underuse of Follow-Up Testing The ASCO Panel suggests that the clinician should consider rechecking CEA if the test result is going up or going up and down; in this case, rechecking is not overuse, because it is not surveillance but follow-up of abnormal results and appropriate use to test more frequently (Table 5 in CCO Guideline; ASCO Data Supplement 2). The ASCO Panel also emphasizes that overuse must be considered differently for high-risk versus low-risk patients, so it is better to have some flexibility in following these patients. Additional testing should not always be considered overuse.
or institution-based nurse-coordinated care. The Panel wants to emphasize the need to provide the patient and the patient’s other providers, including the primary care physician, a treatment summary as well as guidance on surveillance schedule. Secondary Prevention of CRC There are emerging data on the role of various host factors, including diet and lifestyle, as secondary prevention for CRC survivors.18,19 While such data are based on prospective, observational studies and lack confirmation from randomized clinical trials to date, the Panel agrees with the CCO Guideline for secondary prevention in CRC survivors. Patients should seek to maintain a healthy body weight. Survivors should engage in a physically active lifestyle, seeking to follow the recommendation of the American College of Sports Medicine to strive to engage in at least 150 minutes a week of moderate-intensity, or 75 minutes (1 hour and 15 minutes) a week of vigorous-intensity aerobic physical activity, or an equivalent combination of moderate- and vigorous-intensity aerobic activity.20 However, any level of activity that the patient can do is considered better than being physically inactive. Survivors should be advised to eat a healthy diet. There remains uncertainty regarding regular use of an aspirin21,22 or cyclooxygenase inhibitor and in which survivors; however, an ongoing randomized clinical trial (CALGB [Cancer and Leukemia Group B] 80702) is being conducted by the National Cancer Institute cooperative groups on whether celecoxib will improve outcomes in CRC survivors.23 Other interventions, including vitamin D, also require further study to help provide guidance for secondary prevention. ENDORSEMENT RECOMMENDATION
The ASCO Panel and the CPGC have reviewed the CCO Guideline and endorse the adoption of this guideline, with the minor qualifying statements above. AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest.
AUTHOR CONTRIBUTIONS
Communication With Patient’s Other Providers Emerging evidence suggests that it is a reasonable option for CRC survivors who have completed all treatment to be discharged from specialist-led care to community-based family physician– coordinated REFERENCES 1. Earle C, Annis R, Sussman J, et al: Follow-up care, surveillance protocol, and secondary prevention measures for survivors of colorectal cancer. https:// www.cancercare.on.ca/common/pages/UserFile .aspx?fileId⫽124839 2. Cairns SR, Scholefield JH, Steele RJ, et al: Guidelines for colorectal cancer screening and surveillance in moderate and high risk groups (update from 2002). Gut 59:666-689, 2010 www.jco.org
Administrative support: Pamela B. Mangu Manuscript writing: All authors Final approval of manuscript: All authors
3. Glimelius B, Påhlman L, Cervantes A: Rectal cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 21:v82v86, 2010 (suppl 5) 4. Labianca R, Nordlinger B, Beretta GD, et al: Primary colon cancer: ESMO clinical practice guidelines for diagnosis, adjuvant treatment and followup. Ann Oncol 21:v70-v77, 2010 (suppl 5) 5. National Comprehensive Cancer Network: NCCN guidelines. http://www.nccn.org/professionals/ physician_gls/f_guidelines.asp 6. Reference deleted
7. Cancer Care Ontario: Follow-up of patients with curatively resected colorectal cancer. https://www.cancercare.on.ca/common/pages/ UserFile.aspx?fileId⫽14014 8. Rex DK, Kahi CJ, Levin B, et al: Guidelines for colonoscopy surveillance after cancer resection: A consensus update by the American Cancer Society and US Multi-Society Task Force on Colorectal Cancer. CA Cancer J Clin 56:160-167, 2006; quiz 185-186 9. Desch CE, Benson AB 3rd, Somerfield MR, et al: Colorectal cancer surveillance: 2005 update of an
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American Society of Clinical Oncology practice guideline. J Clin Oncol 23:8512-8519, 2005 10. Australian Cancer Network: Clinical practice guidelines for the prevention, early detection and management of colorectal cancer. http://www.nhmrc.gov.au/ publications/synopses/cp106/cp106syn.htm 11. Anthony T, Simmang C, Hyman N, et al: Practice parameters for the surveillance and follow-up of patients with colon and rectal cancer. Dis Colon Rectum 47:807-817, 2004 12. New Zealand Guidelines Group: Guidance on surveillance for people at increased risk of colorectal cancer. http://www.health.govt.nz/publication/guidancesurveillance-people-increased-risk-colorectal-cancer 13. Sargent DJ, Patiyil S, Yothers G, et al: End points for colon cancer adjuvant trials: Observations and recommendations based on individual patient data from 20,898 patients enrolled onto 18 randomized trials from the ACCENT Group. J Clin Oncol 25:4569-4574, 2007
14. Mant D, Perera R, Gray A, et al: Effect of 3-5 years of scheduled CEA and CT follow-up to detect recurrence of colorectal cancer: FACS randomized controlled trial. J Clin Oncol 31, 2013 (suppl; abstr 3500) 15. Gunderson LL, Jessup JM, Sargent DJ, et al: Revised TN categorization for colon cancer based on national survival outcomes data. J Clin Oncol 28: 264-271, 2010 16. Baxter NN, Hartman LK, Tepper JE, et al: Postoperative irradiation for rectal cancer increases the risk of small bowel obstruction after surgery. Ann Surg 245:553-559, 2007 17. Quirke P, Morris E: Reporting colorectal cancer. Histopathology 50:103-112, 2007 18. Meyerhardt JA, Ma J, Courneya KS: Energetics in colorectal and prostate cancer. J Clin Oncol 28:4066-4073, 2010 19. Rock CL, Doyle C, Demark-Wahnefried W, et al: Nutrition and physical activity guidelines for
cancer survivors. CA Cancer J Clin 62:243-274, 2012 20. Schmitz KH, Courneya KS, Matthews C, et al: American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc 42:1409-1426, 2010 21. Sandler RS, Halabi S, Baron JA, et al: A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer. N Engl J Med 348:883-890, 2003 22. National Cancer Institute: Colorectal cancer prevention: Aspirin. http://www.cancer.gov/cancertopics/ pdq/prevention/colorectal/HealthProfessional/ page2#Section_964 23. Oxaliplatin, leucovorin calcium, and fluorouracil with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. http://clinicaltrials.gov/ct2/show/NCT01150045?term⫽ CALGB⫹80702&rank⫽1
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Acknowledgment The Panel wishes to thank Alok Khorana, MD, and Yousef Zafar, MD, and the full Clinical Practice Guidelines Committee for their thoughtful reviews of earlier drafts. Appendix
Table A1. Members of the ASCO Guideline Panel Panel Member
Institution
Al B. Benson III, Co-Chair Jeffrey A. Meyerhardt, Co-Chair Patrick J. Flynn Larissa Korde Charles L. Loprinzi Bruce D. Minsky Nicholas J. Petrelli Kim Ryan Deborah H. Schrag Sandra L. Wong
Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL Dana-Farber Institute, Boston, MA Minnesota Oncology, Minneapolis, MN University of Washington, Seattle, WA Mayo Clinic, Rochester, MN MD Anderson Cancer Center, Houston, TX Helen Graham Cancer Center, Newark, DE Fight Colorectal Cancer, Alexandria, VA Dana-Farber Cancer Institute, Boston, MA University of Michigan Medical School, Ann Arbor, MI
Abbreviation: ASCO, American Society of Clinical Oncology.
Table A2. Rigour of Development Subscale of the Appraisal of Guidelines for Research and Evaluation II Instrument Rigor of Development Subscale Item Systematic methods were used to search for evidence. The criteria for selecting the evidence are clearly described. The strengths and limitations of the body of evidence are clearly described. The methods used for formulating the recommendations are clearly described. The health benefits, side effects, and risks have been considered in formulating the recommendations. There is an explicit link between the recommendations and the supporting evidence. The guideline has been externally reviewed by experts prior to its publication. A procedure for updating the guideline is provided. NOTE. Each subscale item is rated on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). The score for the Rigour of Development domain is calculated by summing the scores across individual items in the domain and across all raters, subtracting the lowest possible score for that domain (1 ⫻ No. of items ⫻ No. of raters), then standardizing the total score as a proportion of the maximum possible score (7 ⫻ No. of items ⫻ No. of raters) minus the lowest possible score.
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Table A3. ASCO Guideline Endorsement Content Review Formⴱ Statement
Strongly Agree
Agree
Neither Agree or Disagree
Disagree
Strongly Disagree
Unsure
The results of the studies described in this guideline are interpreted according to my understanding of the data. The recommendations in this report are clear. I agree with the recommendations as stated in the guideline. The recommendations are suitable for the patients for whom they are intended. The recommendations are too rigid to apply to individual patients. When applied, the recommendations will produce more benefits for patients than harms. The guideline presents options that will be acceptable to patients. The guideline should be endorsed by ASCO.
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NOTE. This form was adapted from the Cancer Care Ontario Program in Evidence-Based Care Practitioner Feedback instrument. Abbreviation: ASCO, American Society of Clinical Oncology. ⴱ Background and instructions when filling in the form are given as follows: ASCO considers clinical practice guidelines developed by other professional organizations for endorsement. This is done by ASCO most often in lieu of undertaking its own guideline on the same topic. You have been asked to provide a content review of a guideline that is under consideration for endorsement by ASCO. Please check the box that best applies for each of the following items. Guideline title, organization, and reviewer name are also provided.
© 2013 by American Society of Clinical Oncology
JOURNAL OF CLINICAL ONCOLOGY
Downloaded from jco.ascopubs.org on June 5, 2015. For personal use only. No other uses without permission. Copyright © 2013 American Society of Clinical Oncology. All rights reserved.
