Journal List > Korean J Urol > v.49(4) > 1005087

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Kim, Cho, Yeo, Park, and Yoon: Initial Experiences of Intravesical Gemcitabine Instillation Followed by Bacillus Calmette-Guerin (BCG) Therapy for Treating Intermediate or High Risk Patients with Superficial Bladder Cancer
Original Article
Korean Journal of Urology

Korean Journal of Urology 2008; 49(4): 313-319.

Published online: 30 April 2008

DOI: https://doi.org/10.4111/kju.2008.49.4.313

Initial Experiences of Intravesical Gemcitabine Instillation Followed by Bacillus Calmette-Guerin (BCG) Therapy for Treating Intermediate or High Risk Patients with Superficial Bladder Cancer

Jong Wook Kim, Dae Yeon Cho, Jeong Kyun Yeo, Hong Seok Park, Duck Ki Yoon

Department of Urology, College of Medicine, Korea University, Seoul, Korea.

dkyoon@korea.ac.kr

Received 18 December 2007       Accepted 17 March 2008

Copyright © 2008 The Korean Urological Association

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.

Keywords: Gemcitabine, Bladder cancer, Intravesical instillation

Figures and Tables

Fig. 1
Kaplan-Meier curves show the recurrence-free survival according to the gemcitabine intravesical instillation followed by Bacillus Calmette-Guerin (BCG) (group I) versus BCG only (group II). No difference was observed between the two groups (p=0.952).
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Table 1
Baseline characteristics
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*: of patients in recurrence, †: statistical analysis by chi-square equation, ‡: statistical analysis by Student's t-test, §: statistical analysis by Fisher's exact test, BCG: Bacillus Calmette-Guerin, TUR: transurethral resection

Table 2
Comparison of the results between group I and group II
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*: p-value<0.05, †: statistical analysis by Fisher's exact test, ‡: statistical analysis by chi-square equation, §: statistical analysis by Student's t-test, ANC: absolute neutrophil count

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