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No increased survival benefit to intensive follow-up after colorectal cancer surgery

Clinical Question:
Does intensive follow-up after surgery for colorectal cancer reduce morbidity and mortality?

Bottom Line:
Compared with minimal follow-up after surgery for colorectal cancer, intensive follow-up with regular computed tomography (CT), carcinoembryonic antigen (CEA) testing, or both results in more patients undergoing repeat surgery but no reduction in overall mortality or disease-specific mortality. Overall deaths were actually higher, but not significantly so, in the more intensive follow-up groups compared with the minimum follow-up group (18.2% vs 15.9%). Serial testing of CEA was as effective as serial CT. (LOE = 1b)

Reference:
Primrose JN, Perera R, Gray A, et al, for the FACS Trial Investigators. Effect of 3 to 5 years of scheduled CEA and CT follow-up to detect recurrence of colorectal cancer. The FACS randomized clinical trial. JAMA 2014;311(3):263-270  [PMID:24430319]

Study Design:
Randomized controlled trial (single-blinded)

Funding:
Government

Allocation:
Concealed

Setting:
Outpatient (any)

Synopsis:
The optimal program for follow-up after surgery for colorectal cancer is uncertain. These investigators identified adults (N = 1202; mean age = 69 years) with a history of curative surgery for primary colorectal cancer with no residual disease (Dukes stage A to C with microscopically clear margins) confirmed by CT or a magnetic resonance imaging liver scan and chest CT scan and with normal postoperative blood CEA level. Eligible patients randomly received assignment (concealed) to 1 of 4 types of follow-up: (1) CEA follow-up, with measurement of blood CEA every 3 months for 2 years, then every 6 months for 3 years with an optional single chest, abdomen, and pelvis CT scan at 12 to 18 months if requested at study entry by supervising clinician; (2) CT follow-up, with CT of the chest, abdomen, and pelvis every 6 months for 2 years, then annually for 3 years; (3) CEA and CT follow-up; or (4) minimum follow-up, with no scheduled follow-up except the option of a single CT scan of chest, abdomen and pelvis if requested at study entry by supervising clinician. All patients were offered colonoscopy after 5 years, and patients in the 2 CT groups also underwent colonoscopy after 2 years. The study was underpowered to detect a significant difference in all-cause mortality, so the primary outcome measured was repeat surgical treatment of recurrent disease with curative intent. Individuals who assessed outcomes remained masked to treatment group assignment. Complete follow-up occurred for all patients at 5 years. Using intention-to-treat analysis, cancer recurred in 199 patients (16.6%). Of these, 71 patients (5.9%) underwent repeat surgery for curative intent. Surgical treatment of recurrence with curative intent was significantly higher in each of the 3 more intensive follow-up groups compared with the minimum follow-up group (absolute difference ranged from 4.3% to 5.7%; numbers needed to treat = 12 to 20 for closer monitoring to identify 1 potentially curable recurrence), with no difference in repeat surgery for the combined CT plus CEA group compared with the CT or CEA alone groups. Overall deaths were actually higher, but not significantly so, in the more intensive follow-up groups than in the minimum follow-up group (18.2% vs 15.9%). Disease-specific mortality was also nonsignificantly increased in the more intensive follow-up groups (10.4% vs 9.3%). The investigators also performed a per-protocol analysis excluding 308 patients who missed more than one scheduled visit and found results consistent with the intention-to-treat analysis.

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