Korean J Urol.  2008 Apr;49(4):313-319.

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

• Kim JW
• Cho DY
• Yeo JK
• Park HS
• Yoon DK

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.

Keyword

Gemcitabine; Bladder cancer; Intravesical instillation

MeSH Terms

Administration, Intravesical
Bacillus
Deoxycytidine
Humans
Mycobacterium bovis
Prospective Studies
Recurrence
Urinary Bladder
Urinary Bladder Neoplasms
Deoxycytidine

Figure

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  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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