Colorectal Cancer Surveillance: 2005 Update Clinical Practice Guideline

1. Colorectal Cancer Surveillance: 2005 Update Clinical Practice Guideline

2. Introduction • The 2005 guidelines are designed for the surveillance of patients following treatment for stage II or III colorectal cancer. • Occasionally, guidelines for colon and rectal cancer may differ. • The rationale for the guideline is finding the balance between identifying curable recurrences and minimizing ineffective tests and the costs associated with them. • The panel limited its attention to sporadic cases of colon and rectal cancer. Patients with hereditable cancers may need more frequent attention.

3. Background Estimated colorectal cancer cases (U.S.), 2005: 145,290 60% of these patients will present with stage II or III disease & 35% to 40% of them will recur with metastatic or locally invasive disease Hundreds of thousands of people with resected colorectal cancer are candidates for surveillance.

4. Background (cont’d) The majority of recurrences in patients who have undergone a complete resection of a colorectal cancer will occur within 5 years, and usually within 3 years of surgery. Because metastatic disease is usually fatal, effort has been focused on finding recurrences before symptoms develop, at a stage when another curative resection is still possible. 1 2 3 4 5

5. Benefits from the Resection of Metastatic Colorectal Cancer • One third or more of patients with liver metastases can be cured with resection • Over 50 percent of lung metastases can be cured by surgery Fong Y, Cohen AM, Fortner JG, et al. Liver resection for colorectal metastases. J Clin Oncol. 1997 Mar;15(3):938-46. Kato T, Yasui K, Hirai T, et al. Therapeutic results for hepatic metastasis of colorectal cancer with special reference to effectiveness of hepatectomy: analysis of prognostic factors for 763 cases recorded at 18 institutions. Dis Colon Rectum. 2003 Oct;46(10 Suppl):S22-31. Ike H, Shimada H, Ohki S, et al. Results of aggressive resection of lung metastases from colorectal carcinoma detected by intensive follow-up. Dis Colon Rectum. 2002 Apr;45(4):468-73.

6. Background (cont’d) The findings from studies of postoperative monitoring in colorectal cancer have varied widely, leading to: • Considerable variation in follow-up practice. • Wide variation in follow-up costs. ? ? $ A 28-fold difference between Medicare-allowed charges over a 5-year period ranged from $561 to $16,492

7. Guideline Methodology • An ASCO Expert Panel completed a review and analysis of data published since 1999: • MEDLINE • Cochrane Collaboration Library

8. 2005 Categories of Recommendations (5) for Colorectal Cancer Surveillance • History and physical examination and risk assessment • Laboratory tests • Imaging Procedures • Endoscopic surveillance techniques • Laboratory-based prognostic and predictive factors

9. History and Physical and Risk Assessment2005 Recommendations • Coordinating physician visits • Every 3-6 months during years 1, 2, 3 • Every 6 months during years 4, 5 • Subsequently, physician’s discretion

10. History and Physical and Risk Assessment2005 Recommendations (cont’d) • Focus on initial risk assessment • Implement surveillance strategy & periodic counseling based on • Estimated risk • Feasibility of surgical interventions

11. History and Physical and Risk AssessmentRationale and Considerations • 85% of colon cancer recurrences are diagnosed within the first 3 years after surgical resection of the primary tumor. • The frequency, duration, and benefit of the follow-up visit itself have never been formally tested; however, the concept of a risk-based plan, and the tools to formulate it, have improved. • Longer follow-up may be appropriate for locally advanced rectal cancer patients with poor prognostic factors due to continuing risk of recurrence after 5 years.

12. History and Physical and Risk AssessmentRationale and Considerations (cont’d) • Currently, other than stage and subsets within a stage, there is no single pathologic feature or statistical model that can be used to build a surveillance strategy. • The Mayo Clinic calculator: http://www.mayoclinic.com/calcs or http://www.adjuvantonline.com estimates 5-year relapse-free survival both with and without treatment using data available on most pathology reports.

13. History and Physical and Risk AssessmentRationale and Considerations (cont’d) Data from Mayo Clinic Calculator

14. Laboratory Tests2005 Recommendations Carcinoembryonic Antigen • Every 3 months for at least 3 years after diagnosis • If the patient is a candidate for surgery or systemic therapy • Caution: 5-FU-based therapy may falsely increase CEA values – wait until adjuvant treatment is finished before initiating surveillance

15. Laboratory Tests2005 Recommendations (cont’d): • Blood Tests • Routine blood tests (i.e., complete • blood counts or liver function tests) • are not recommended. • Fecal Occult Blood Test • Periodic fecal occult blood testing • is not recommended. CEA CBC LFTs FOBT

16. Imaging Procedures2005 Recommendations Computed Tomography • Annual CT of the chest & abdomen for 3 years • Patients at higher risk, who could be candidates for curative-intent surgery • Pelvic CT scan (rectal cancer) • Especially for patients who have not been treated with radiotherapy.

17. Imaging Procedures2005 Recommendations (cont’d) Chest X-Ray • Annual chest X-rays are not recommended.

18. Imaging ProceduresRationale and Considerations • In patients undergoing liver imaging, there is a 25% lower mortality compared to non-imaging strategies. • Despite earlier controversy among Panel members about the value of chest x-rays, since the Panel has recommended annual CT scanning for high-risk patients who are candidates for resection, routine chest x-rays are probably not relevant.

19. Qualifications to CT Recommendation • There are no data that specify the frequency of CT scanning. • CT scanning should not be routinely ordered in patients who would or could not undergo curative liver or pulmonary resection. • The data do not justify routine pelvic imaging (although CT scans of the abdomen and pelvis are frequently ordered together). • The Panel did not rigidly define “higher risk”; the risk-based plan developed by the doctor and patient at the beginning of the follow-up period cannot be underemphasized.

20. Endoscopic Surveillance Techniques2005 Recommendations Colonoscopy • For the pre- or perioperative documentation of a cancer- and polyp-free colon. • Normal risk: a colonoscopy at 3 years and then, if normal, every 5 years thereafter. • High-risk genetic syndromes: consider the guideline published by the AGA.

21. Endoscopic Surveillance Techniques2005 Recommendations (cont’d) Flexible Protosigmoidoscopy (Rectal Cancer) Every 6 months for 5 years • In patients who have not received pelvic radiation

22. Laboratory-Derived Prognostic and Predictive Factors2005 Recommendations Use of molecular or cellular markers should not influence the surveillance strategy. Cellular Markers Molecular Markers

23. Summary Recommended Coordinating physician visits Risk assessment CEA testing CT scans Colonoscopy Flexible proctosigmoidoscopy Not Recommended CBC LFT FOBT Chest X-ray Molecular or cellular markers

24. Additional ASCO Resources • The full text of the 2005 updated guideline is available at http://www.jco.org/cgi/reprint/JCO.2005.04.0063v1 • A Patient Guide is available at http://www.plwc.org/plwc/external_files/Colorectal_Cancer_Patient_Guide.pdf • A Guideline Summary, Surveillance Flow Sheets for individual patient follow up , and links to the resources listed above are available online at http://www.asco.org/guidelines/crcfollowup

25. Additional ASCO Resources (cont’d)Print Flow Sheet (Rectal Cancer)

26. Additional ASCO Resources (cont’d)Interactive Flow Sheet (Rectal Cancer)

27. ASCO Guidelines