Management Of Superficial Bladder Tumors: Celecoxib For The Treatment Of Non-Muscle Invasive Bladder

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 06 Apr 2008 - 0:00 PDT

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UroToday.com - Cyclooxygenase-2 (Cox-2) expression increases with bladder cancer tumor grade and stage. Dr. Pagliarulo presented preliminary results from a clinical trial to evaluate the safety and efficacy of the selective inhibitor of Cox-2, celecoxib, in Ta and T1 bladder cancer patients

From 2003 through 2006, all patients with naive non-muscle invasive transitional cell carcinoma (TCC) of the bladder undergoing transurethral resection (TUR) were considered for treatment with celecoxib. Major exclusion criteria were patient's choice, previous history of cardiac or cerebral vascular disease, any bowel inflammatory disease, gastric hypersecretion and/or bleeding, known intolerance to NSAIDs, previous chronic use of NSAIDs, including cardiospirin, and carcinoma in situ of the bladder. Accordingly, 61 eligible patients were treated with celecoxib 400 mg twice daily, and were compared to 56 non-eligible patients who received no treatment. Celecoxib was administered for 1 year, starting within 1 week from TUR. All patients were prospectively followed with flexible cystoscopy quarterly for the first 2 years, bi-annually for the third year and yearly thereafter, if no relapse occurred. Recurrence, progression (stage and grade), and adverse events were strictly monitored. The level of significance for comparative analyses was set at 0.05. Duration of response and progression-free survival were analyzed with the use of Kaplan Meier techniques. Univariate and multivariate analyses were performed using chi-square and log-rank tests, and a logistic regression model, respectively.

At a median follow-up of 29.4 months, overall recurrence and progression rates were not significantly different between the 2 cohorts of patients. Nevertheless, after stratification for stage and grade, higher risk patients who received celecoxib had stronger protection, with lower recurrence(p=0.01) and progression (p<0.001) rates. Overall time to first recurrence was significantly prolonged by celecoxib compared to TUR alone (p<0.001). Progression to muscle invasion was rare (2.5 % of cases) and not different in the 2 arms. Treatment was clinically well tolerated in all patients. Treatment was suspended in 5 patients, because of angina (1), gastric pain (3), and edema (1). There was no remarkable systemic toxicity on hematology or biochemistry.

Presented by: V. Pagliarulo, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD

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