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Celecoxib for the prevention of nonmuscle invasive bladder cancer: results from a matched control study
Vincenzo Pagliarulo1, Patrizia Ancona2, Ivan Martines2
1Urology and Andrology Unit, Department of Emergency and Organ Transplantation, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy.
Objectives:
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.
Insights
This pilot study suggests celecoxib may offer a clinical benefit for preventing recurrence in nonmuscle invasive bladder cancer (NMIBC) patients. Further trials are encouraged to explore COX-2 inhibitors in select NMIBC cases.
Area of Science:
- Oncology
- Urologic Oncology
- Cancer Therapeutics
Background:
- Nonmuscle invasive bladder cancer (NMIBC) requires novel therapeutic targets.
- Cyclooxygenase-2 (COX-2) inhibition shows promise in preclinical bladder cancer models.
- Celecoxib, a selective COX-2 inhibitor, demonstrated anti-tumor effects in vitro and in vivo.
Purpose of the Study:
- To evaluate the efficacy of celecoxib in preventing recurrence in intermediate-risk NMIBC patients.
- To compare celecoxib treatment with standard intravesical mitomycin C (MMC) therapy.
- To assess adverse events associated with celecoxib in NMIBC patients.
Main Methods:
- A pilot study comparing oral celecoxib (12 months) with intravesical mitomycin C (MMC) (15 months).
- Primary endpoints included time to first recurrence and safety (adverse events).
- Median follow-up was 75 months, with 58 patients in the celecoxib group and 66 in the MMC group.
Main Results:
- Disease-free rates were 44.8% for celecoxib and 34.85% for MMC.
- Median disease-free intervals were 67 months (celecoxib) vs. 41 months (MMC), though not statistically significant (p=0.25).
- No significant difference in recurrence or adverse events between the two treatment groups.
Conclusions:
- Data suggest a potential clinical benefit of celecoxib for NMIBC patients.
- Further clinical trials investigating COX-2 inhibitors in selected NMIBC populations are warranted.
- Celecoxib demonstrated comparable safety to MMC in this pilot study.
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