Progression was seen in 32% of 56 volunteers who received the combination for up to four years compared with 38% of 58 who got sulindac alone and 40% of the 57 treated with eflornithine alone.
Those differences were not statistically significant, the researchers report in The New England Journal of Medicine. For the comparison of the drug combination against sulindac, the hazard ratio was 0.71, but the 95% confidence interval was 0.39 to 1.32. Against eflornithine, that hazard ratio was 0.66, with a confidence interval of 0.36 to 1.23.
A 2018 study published in JAMA Oncology concluded that the combination was better than placebo, decreasing the number of polyps in the duodenum by about 70%. But the new study compared the combination to the individual drugs.
"Despite the fact that this trial was larger than previous trials on pharmacologic prevention in patients with familial adenomatous polyposis, it was relatively small, and the 95% confidence intervals for our hazard ratios were wide for this small sample size," Dr. Carol Burke of the Cleveland Clinic in Ohio and colleagues write.
The study was funded by Cancer Prevention Pharmaceuticals. In June, the Tuscon-based company issued a news release acknowledging that the combination did not do better than the individual drugs.
"However," the company said, "further analysis of the data showed key differential effects of the agents in the lower vs upper GI anatomy. Focusing on lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), the data showed statistically significant benefit" for the combination in delaying surgical events for that region.
By Reuters Staff
SOURCE: https://bit.ly/2QY9TPN The New England Journal of Medicine, online September 9, 2020.
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