title: Celecoxib for the prevention of nonmuscle invasive bladder cancer: results from a matched control study.
abstract: 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.
authors.affiliation: Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Pagliarulo
authors.affiliation: Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Ancona
authors.affiliation: Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
authors.forename: Ivan
authors.initials: I
authors.lastname: Martines
authors.affiliation: Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
authors.forename: Rossana
authors.initials: R
authors.lastname: Spadavecchia
authors.affiliation: Department of Surgery/Urology, Tor Vergata University, Rome, Italy.
authors.forename: Savino
authors.initials: S
authors.lastname: Di Stasi
authors.affiliation: Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Alba
authors.affiliation: Department of Urology and Renal Transplantation, University of Foggia, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Cormio
authors.affiliation: Department of Clinical Pharmacology and Epidemiology, Fondazione Mario Negri Sud, Santa Maria Imbaro, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Fanizza
authors.affiliation: Department of Urology, University Hospital Campus Bio-Medico, Rome, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Salerno
authors.affiliation: Department of Urology and Renal Transplantation, University of Foggia, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Carrieri
authors.affiliation: Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
authors.forename: Arcangelo
authors.initials: A
authors.lastname: Pagliarulo
keywords: bladder cancer; celecoxib; cyclooxygenase; recurrence; treatment