Abstract | Importance: Objective: Design, Setting, and Participants: Prespecified secondary analysis for colorectal adenoma regression was carried out using data from a double-blind, randomized, placebo-controlled trial, enrolling 92 patients with FAP, conducted from July 2010 to June 2014 in Salt Lake City, Utah. Interventions: Patients were randomized to sulindac, 150 mg twice daily, and erlotinib, 75 mg daily (n = 46), vs placebo (n = 46) for 6 months. Main Outcomes and Measurements: The total number of polyps in the intact colorectum, ileal pouch anal anastomosis, or ileo-rectum were recorded at baseline and 6 months. The primary outcomes were change in total colorectal polyp count and percentage change in colorectal polyps, following 6 months of treatment. Results: Eighty-two randomized patients (mean [SD] age, 40 [13] years; 49 [60%] women) had colorectal polyp count data available for this secondary analysis: 22 with intact colon, 44 with ileal pouch anal anastomosis and 16 with ileo-rectal anastomosis; 41 patients received sulindac/ erlotinib and 41 placebo. The total colorectal polyp count was significantly different between the placebo and sulindac- erlotinib group at 6 months in patients with net percentage change of 69.4% in those with an intact colorectum compared with placebo (95% CI, 28.8%-109.2%; P = .009). Conclusion and Relevance: In this double-blind, placebo-controlled, randomized trial we showed that combination treatment with sulindac and erlotinib compared with placebo resulted in significantly lower colorectal polyp burden after 6 months of treatment. There was a reduction in polyp burden in both those with an entire colorectum and those with only a rectal pouch or rectum. Trial Registration: clinicaltrials.gov Identifier: NCT01187901.
|
Authors | N Jewel Samadder, Scott K Kuwada, Kenneth M Boucher, Kathryn Byrne, Priyanka Kanth, Wade Samowitz, David Jones, Sean V Tavtigian, Michelle Westover, Therese Berry, Kory Jasperson, Lisa Pappas, Laurel Smith, Danielle Sample, Randall W Burt, Deborah W Neklason |
Journal | JAMA oncology
(JAMA Oncol)
Vol. 4
Issue 5
Pg. 671-677
(05 01 2018)
ISSN: 2374-2445 [Electronic] United States |
PMID | 29423501
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
|
Chemical References |
- Sulindac
- Erlotinib Hydrochloride
|
Topics |
- Adenomatous Polyposis Coli
(drug therapy, mortality, pathology)
- Adult
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Colorectal Neoplasms
(drug therapy, mortality, pathology)
- Erlotinib Hydrochloride
(administration & dosage)
- Female
- Humans
- Male
- Middle Aged
- Sulindac
(administration & dosage)
- Treatment Outcome
|