Initial experiences on intravesical gemcitabine instillation followed by Bacillus Calmette-Guerin (BCG) therapy for treating intermediate or high risk patients with superficial bladder cancer

Abstract

Purpose: To investigate the safety and the efficacy of intravesical gemcitabine therapy, we prospectively studied intravesical gemcitabine instillation followed by Bacillus Calmette-Guerin (BCG) instillation for treating the patients who suffer from superficial bladder cancer, and the above method was then compared with conventional BCG instillation. Materials and Methods: Between May 2005 and April 2007, a total of 84 patients were divided into Group I: the patients were treated with a 2-week course of gemcitabine (1,000mg/50ml, 2,000mg/50ml) followed by a conventional 6-week course of BCG, and Group II: the patients were treated by BCG instillation only. Gemcitabine was instilled immediately within 6 hours after complete trans-urethral resection of the bladder tumor (TURBT) and then this was repeated one week later. BCG instillation was started 2 weeks after TURBT. The complications, recurrence rates, progression rates and recurrence-free period (RFP) were analyzed in both groups. Results: The treatment was well tolerated in all the patients. Most of the complications were self-limiting, and there was no significant difference between the two groups (p=0.379). The recurrence rates of the two groups were 25.6% and 26.7%, respectively (p=0.899). Yet the recurrence-free period (RFP) was significantly longer in Group I (p=0.021). The progression rates of the two groups were 2.6% and 6.7%, respectively (p=0.620). Conclusions: Intravesical gemcitabine instillation showed the effect to prolong the recurrence-free period for patients with superficial bladder cancer. Further long-term study will be needed.