An international randomised trial of celecoxib versus celecoxib plus difluoromethylornithine in patients with familial adenomatous polyposis
Conclusions
CXB combined with DFMO yielded moderate synergy according to a video-based global assessment. No significant difference in adenoma count, the primary endpoint, was seen between the two study arms. No evidence of DFMO-related ototoxicity was seen. There were no adverse cardiovascular outcomes in either trial arm and no significant increase in AEs in the CXB+DFMO arm of the trial. Differences in outcomes between primary and secondary endpoints may relate to sensitivity of the endpoint measures themselves.
Trial registration number
ClinicalTrials.gov number N01-CN95040.
Source: Gut - Category: Gastroenterology Authors: Lynch, P. M., Burke, C. A., Phillips, R., Morris, J. S., Slack, R., Wang, X., Liu, J., Patterson, S., Sinicrope, F. A., Rodriguez-Bigas, M. A., Half, E., Bulow, S., Latchford, A., Clark, S., Ross, W. A., Malone, B., Hasson, H., Richmond, E., Hawk, E. Tags: Colon cancer Source Type: research
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