Randomized controlled trial of celecoxib to prevent recurrence of non-muscle-invasive bladder cancer - Abstract

1THNMO, UT MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 432, Houston, TX, 77030, United States.


Significant morbidity and expense result from frequent recurrences of non-muscle invasive bladder cancer (NMIBC) after standard treatment, and carcinoma in situ (Tis) is a poor prognostic factor. Predicated on observational and preclinical data strongly supporting cyclooxygenase-2 (COX-2) in pathogenesis and the activity of COX-2 inhibitors in bladder cancer, we conducted a randomized, double-blind, placebo-controlled trial to determine if celecoxib could reduce the time-to-recurrence (TTR) in NMIBC patients at high risk for recurrence. 146 patients were randomized to celecoxib (200 mg) or placebo orally twice daily for at least 12 months. The average treatment duration was 1.25 years. Primary intent-to-treat analysis revealed celecoxib did not statistically significantly prolong TTR compared with placebo (P = 0.17, log-rank). With a median follow-up of 2.49 years the relative risk of recurrence in the celecoxib vs placebo arms was 0.64 (95% CI, 0.38, 1.17). The recurrence-free rate at 12 months with celecoxib was 88% (95% CI, 0.81,0.96) versus 78% (95% CI, 0.69, 0.89) with placebo. However, after controlling for covariates (including Tis) with Cox regression analysis, recurrence rates did not differ between the two study arms (HR = 0.69; 95% CI, 0.37,1.29). Celecoxib had a marginally significant effect on reducing metachronous recurrences (vs. placebo) with hazard ratio (HR) of 0.56 (95% CI, 0.3,1.06; P=0.075). Celecoxib was well tolerated, with similar adverse events and quality-of-life in both arms. Our clinical trial results align with the existing data, and support further investigation of COX-2 inhibitors for prevention of NMIBC recurrence.

Written by:
Sabichi AL, Lee JJ, Grossman HB, Liu S, Richmond E, Czerniak B, Delacerda J, Eagle C, Viner JL, Palmer JL, Lerner SP.   Are you the author?

Reference: Cancer Prev Res (Phila). 2011 Aug 31. Epub ahead of print.
doi: 10.1158/1940-6207.CAPR-11-003

PubMed Abstract
PMID: 21881030

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