The impact of intravesical Gemcitabine and 1/3 dose Bacillus Calmette Guerin instillation therapy on the quality of life in non-muscle-invasive bladder cancer patients: results of a prospective, randomised phase II trial.

BCG and intravesical chemotherapy represent viable adjuvant options in intermediate-risk non-muscle-invasive bladder cancer (NMIBC). Although BCG is perceived as less tolerable than intravesical chemotherapy, no comparative studies have addressed quality of life (QoL) issues. We compared QoL of NMIBC patients who received either adjuvant intravesical gemcitabine or 1/3 dose BCG. MATERIAL AND METHODS: our multicenter, prospective, randomised, phase II study included 120 intermediate-risk NMIBC; 88 remained assessable at 1-year follow-up. Only one patient was withdrawn because of adverse events. 61 patients received gemcitabine 2000 mg/50 cc weekly for 6 weeks (maintenance monthly for one year), while 59 BCG Connaught 1/3 dose weekly for 6 weeks (maintenance 3 weekly instillations at 3, 6 and 12 months). QoL was measured by EORTC QlQ-C30 and BLS-24 questionnaires. Group differences were calculated using analysis of variance (ANOVA/MANOVA). RESULTS: treatment was well-tolerated in both groups, although local and systemic side-effects were more frequent in the BCG-arm. Multivariable analyses showed no significant differences between the two groups in all QoL dimensions. No significant changes over time in QoL domains were detected for both BCG and gemcitabine patients, except for Physical Functioning, which significantly decreased in both groups (p 0.002). No significant differences were detected in terms of recurrence and progression between the two groups at 1 year follow-up. CONCLUSIONS: while a higher rate of side effects, albeit mild to moderate, was detected with 1/3 dose BCG as compared to gemcitabine, our study failed to show significant differences between the two drugs in terms of QoL.