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Sulindac and eflornithine could help delay the need for lower gastrointestinal surgery for FAP patients.
A combination of sulindac and eflornithine might be able to decrease the risk of progression and delay the need for lower gastrointestinal surgery for familial adenomatous polyposis (FAP) patients.
Researchers from the Cleveland Clinic presented new data from a post hoc analysis of a phase 3 trial during the annual American College of Gastroenterology (2020) conference showing the benefit of the combination therapy for patients suffering from the inherited colorectal cancer (CRC) syndrome caused by a germline mutation in the adenomatous polyposis coli gene.
The investigators found this treatment resulted in a benefit in FAP patients with an intact colon, ileorectal anastomosis (IRA), or ileal pouch anal anastomosis (IPAA).
Initially, the investigators tested adults with FAP were randomized to eflornithine 750 mg, sulindac 150 mg or both, once daily for up to 48 months. The team followed up that study with a 158-patient intent-to-treat trial, where patients had either a native lower gastrointestinal tract or a tract reconstructed as a pelvic pouch.
The investigators found disease progression in 3.7% of the 54 patients in the combination arm, 17% of the 53 patients in the sulindac arm, and 19.6% in the 51 patents sin the eflornithine arm. The risk reduction was significant for comparison of the combination treatment with both individual therapy arms, at 80% (HR, 0.20; 95% CI, 0.05-0.80, P = 0.02) for combination therapy compared to sulindac and 83% (HR, 0.17; 95% CI, 0.04-0.70; P = 0.01) compared to eflornithine.
In an interview with HCPLive®, James Church, MD, Director of the Sanford R. Weiss Center for Hereditary Colorectal Neoplasia in the Cleveland Clinic’s Digestive Disease and Surgical Institute, explained how the results will have real world impact for patients.