The effect of gender on response to bacillus Calmette-Guérin therapy for patients with non-muscle-invasive urothelial carcinoma of the bladder.

OBJECTIVE: To determine the influence of gender on the outcome of patients with high-risk non-muscle-invasive bladder cancer treated with intravesical bacille Calmette-Guérin (BCG) therapy, as the role of hormone status in the pathogenesis of urothelial carcinoma and the response to treatment remains subject to debate. PATIENTS AND METHODS: We reviewed 1021 consecutive patients (756 men and 265 women) who were treated with induction BCG between 1978 and 2006 for multiple or recurrent high-grade Ta, T1, and/or carcinoma in situ (CIS) bladder cancer. All patients had > or = 5 years of follow-up. The endpoints of initial response to BCG and the time to disease recurrence and progression were correlated with gender using Kaplan-Meier methods and multivariate Cox regression models.
RESULTS: Men were significantly more likely to present with high grade (P = 0.003) tumours and with CIS (P < 0.001), while age and clinical stage at presentation were similar between men and women. There was no significant difference in the initial response to BCG by gender, as 593/756 (78.4%) men and 219/265 (82.6%) women had no evidence of disease at 6 months after BCG treatment (P = 0.14). The median time to recurrence after BCG therapy was also similar for men and women (20 vs 21 months, P = 0.51). Likewise, there was no evidence of a significant association between gender and the risk of disease progression after BCG therapy, such that the 5-year estimated freedom from progression was 77% and 82%, respectively, for men and women (P = 0.08). Moreover, on a multivariate analysis controlling for patient age and tumour stage, grade and CIS, gender was not associated with the risk of recurrence (hazard ratio 0.94, 95% confidence interval 0.79-1.11; P = 0.44) or progression (1.18, 0.85-1.63; P = 0.33) after BCG. When the outcomes for women treated with BCG were stratified by age <50 years (the median age of menopause in the USA) vs > or = 50 years, again there were no differences in the risk of tumour recurrence (P = 0.95) or progression (P = 0.35).
CONCLUSION: These data suggest that the outcomes of men and women with high risk non-muscle-invasive urothelial carcinoma treated with BCG are similar. As such, further studies are required to determine the clinical relevance of preclinical evidence that has suggested a potential role for sex steroids in the pathophysiology of bladder cancer.