Introduction: Colorectal cancer (CRC) is the second leading cause of cancer mortality in the United States, and routine population-based CRC screening is well-supported by existing studies. Despite this, CRC screening rates have been lagging behind national targets with the CDC reporting only 58.2% of adults between 50-75 years having had recent screening in 2013. To address this important issue, several non-invasive screening assays have been developed. The recently approved Cologuard combines a multitarget stool DNA test with fecal immunochemical testing (FIT) and provides patients with a less invasive, more convenient screening option that demonstrates improved detection of cancers and advanced adenomas over FIT alone. We describe the results of our experience with Cologuard after one year in the clinical setting. Methods: This study was a retrospective chart review of patients who had a Cologuard screening test ordered between 09/01/2015 and 08/31/2016 at Mayo Clinic Arizona. The primary endpoint was the number of positive results. Multiple secondary endpoints were evaluated including noncompliance rate, reasons for not completing the test, and subsequent colonoscopy results. Results: A total of 701 charts were reviewed. Baseline characteristics are listed in Table 1. Of these 701 patients, 367 (52.4%) completed a Cologuard. A positive result was seen in 46 patients (12.5%), and 39 underwent subsequent colonoscopy at our facility. Overall, 7 patients (17.9%) had advanced adenomas, and 7 patients (17.9%) had a false positive result. No colorectal cancer was detected. Table 2 depicts subsequent colonoscopy results. Of the patients who did not complete a Cologuard, 19 (5.7%) ultimately pursued colonoscopy, 30 patients (9%) patients had a lack of insurance coverage and 4 patients (1.2%) underwent other screening modalities. Sixty patients had various other reasons for not pursuing the test. Given the limitations of retrospective chart review, the reason for not completing the test was unknown in 221 patients (66.2%).Table: Table. Baseline CharacteristicsTable: Table. Subsequent Colonoscopy Results for Patients with a Positive CologuardConclusion: Unexpectedly, 47.6% of patients who had a Cologuard ordered did not complete the test. A positive result was seen in 12.5% of patients who completed the test, and there was a false positive rate of 17.9%. Advanced adenomas were seen in 7 patients. No cancer was found. Although the Cologuard is a non-invasive and seemingly more convenient screening modality, noncompliance issues must be kept in mind and infrastructure must be in place to follow up with patients who have not completed screening in a timely manner.
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Bering et al. (2017) studied this question.