Abstract
BackgroundThe survival benefits of colon cancer surveillance programs are well delineated, but less is known about the magnitude of false positive testing. The objective of this study was to estimate the false positive rate and positive predictive value of testing as part of a surveillance program based on national guidelines, and to estimate the degree of testing and resource use needed to identify a curable recurrence.MethodsAnalysis of clinically significant events leading to suspicion of cancer recurrence, false positive events, true cancer recurrences, time to confirmation of diagnosis, and resource use (radiology, blood samples, colonoscopies, consultations) among patients included in a randomised colon cancer surveillance trial.Results110 patients surgically treated for colon cancer were followed according to national guidelines for 1884 surveillance months. 1105 tests (503 blood samples, 278 chest x-rays, 209 liver ultrasounds, 115 colonoscopies) and 1186 health care consultations were performed. Of the 48 events leading to suspicion of cancer recurrence, 34 (71%) represented false positives. Thirty-one (65%) were initiated by new symptoms, and 17 (35%) were initiated by test results. Fourteen patients had true cancer recurrence; 7 resections of recurrent disease were performed, 4 of which were successful R0 metastasis Resections. 276 tests and 296 healthcare consultations were needed per R0 resection; the cost per R0 surgery was £ 103207. There was a 29% probability (positive predictive value) of recurrent cancer when a diagnostic work-up was initiated based on surveillance testing or patient complaints.ConclusionWe observed a high false positive rate and low positive predictive value for significant clinical events suggestive of possible colorectal cancer relapse in the setting of a post-treatment surveillance program based on national guidelines. Providers and their patients should have an appreciation for the modest positive predictive value inherent in colorectal cancer surveillance programs in order to make informed choices, which maximize quality of life during survivorship. Better means of tailoring surveillance programs based on patient risk would likely lead to more effective and cost-effective post-treatment follow-up.Trial registrationClinicalTrials.gov identifier NCT00572143. Date of trial registration: 11th of December 2007.
Highlights
The survival benefits of colon cancer surveillance programs are well delineated, but less is known about the magnitude of false positive testing
Data from a randomised trial assessing a colon cancer surveillance program based on Norwegian National Guidelines (ClinicalTrials.gov identifier NCT00572143), was linked to follow-up data from the electronic medical records (EMRs) of four Norwegian hospitals [8,9]
The total surveillance time was 1884 person-months; median follow up time was 17 months
Summary
The survival benefits of colon cancer surveillance programs are well delineated, but less is known about the magnitude of false positive testing. The survival benefits of a surveillance program for colon cancer survivors are well known, but much less is known about the potential negative impacts for patients and their loved ones [3]. In order to more rationally weigh benefits and harms of post-operative surveillance programs, patients and providers need information to help them better understand the implications of positive and negative test results [6]. It is important to understand the resource use associated with work-up of suspected recurrence and the benefit which can be expected in terms of opportunities for curative treatment of recurrence
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