Celecoxib for the prevention of nonmuscle invasive bladder cancer: results from a matched control study

OBJECTIVE - New targets and approaches are under investigation for the treatment of nonmuscle invasive bladder cancer (NMIBC). Preclinical data suggest cyclooxygenase-2 (COX-2) as a promising target. Celecoxib, a COX-2 selective inhibitor, inhibits tumor development and enhances survival, both in vitro and in vivo models of bladder cancer.

Therefore, we conducted a pilot study of celecoxib to prevent recurrence in patients with intermediate risk NMIBC.

METHODS - Treatment with celecoxib was administered orally for 12 months and compared with a contemporary series of patients treated with intravesical mitomycin C (MMC), given weekly for 4 weeks and then monthly for 11 months. Primary endpoints were time to first recurrence and adverse events.

RESULTS - From 2003 through 2006, 58 patients were treated with celecoxib and compared with 66 patients receiving MMC. After a median follow up of 75 months, 49 patients were disease free, including 23 (34.85%) in the MMC group and 26 (44.8%) in the celecoxib group. Median disease-free interval was 67 months [95% confidence interval (CI) 35.8 to NA] versus 41 months (95% CI 27.1-67.1; log-rank p = 0.25) for patients treated with MMC and celecoxib, respectively. In the multivariate analysis, treatment was not found to be an independent predictor for recurrence [hazard ratio (HR) 0.76, 95% CI 0.47-1.22, p = 0.25). Overall, 45 AEs were recorded in 35/124 patients. There were no differences between the two groups.

CONCLUSIONS - Our data support a clinical benefit of celecoxib and encourage future trials in which COX-2 inhibitors may be tested in selected patients with NMIBC.

Therapeutic advances in urology. 2015 Dec [Epub]

Vincenzo Pagliarulo, Patrizia Ancona, Ivan Martines, Rossana Spadavecchia, Savino Di Stasi, Stefano Alba, Luigi Cormio, Caterina Fanizza, Annamaria Salerno, Giuseppe Carrieri, Arcangelo Pagliarulo

Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy., Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy., Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy., Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy., Department of Surgery/Urology, Tor Vergata University, Rome, Italy., Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy., Department of Urology and Renal Transplantation, University of Foggia, Italy., Department of Clinical Pharmacology and Epidemiology, Fondazione Mario Negri Sud, Santa Maria Imbaro, Italy., Department of Urology, University Hospital Campus Bio-Medico, Rome, Italy., Department of Urology and Renal Transplantation, University of Foggia, Italy., Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.