A randomized controlled trial of celecoxib to prevent recurrence of
nonmuscle-invasive bladder cancer.
Author(s): Sabichi AL, Lee JJ, Grossman HB, Liu S, Richmond E, Czerniak BA, De la Cerda J,
Eagle C, Viner JL, Palmer JL, Lerner SP.
Affiliation(s): Department of Medicine, Division of Hematology/Oncology, Baylor College of
Medicine, Houston, Texas 77030, USA. sabichi@bcm.edu
Publication date & source: 2011, Cancer Prev Res (Phila). , 4(10):1580-9
Significant morbidity and expense result from frequent recurrences of
nonmuscle-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 the
pathogenesis, and the activity of COX-2 inhibitors, in bladder cancer, we
conducted a randomized, double-blind, placebo-controlled trial to determine
whether celecoxib could reduce the time-to-recurrence (TTR) in NMIBC patients at
high risk for recurrence. A total of 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 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. After controlling for covariates with Cox regression
analysis, recurrence rates did not differ between the two study arms (HR = 0.69;
95% CI: 0.37-1.29). However, celecoxib had a marginally significant effect on
reducing metachronous recurrences (vs. placebo) with 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 do not show a
clinical benefit for celecoxib in preventing NMIBC recurrence but further
investigation of COX-2 inhibitors in this setting is warranted.
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