Article

Bacillus Calmette-Guérin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer: a randomised prospective study.

Section of Urology and Andrology, Department of Medical-Surgical Specialties and Public Health, University of Perugia, Perugia, Italy.
Urologia Internationalis (impact factor: 0.99). 01/2010; 84(1):23-7. DOI:10.1159/000273461 pp.23-7
Source: PubMed

ABSTRACT To evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine versus bacillus Calmette-Guérin (BCG) in the treatment of high-risk superficial bladder cancer.
64 patients with high-risk superficial bladder cancer (pT1 and/or G3 and/or CIS) were assigned to interventions (gemcitabine or BCG) in a randomised controlled trial. All the patients were evaluated for recurrence and progression rates (primary endpoint) and safety and tolerability (secondary endpoint).
The two groups were comparable in terms of baseline characteristics. Tolerability was better for gemcitabine, whereas the BCG group experienced the need for delayed treatment or withdrawal in 12.5% of cases. At a mean follow-up of 44 months, the recurrence rate in patients treated with BCG was 28.1%; the recurrence rate in patients who received gemcitabine was 53.1% (p = 0.037). Time to recurrence was shorter in patients treated with BCG (25.6 vs. 39.4 months, p = 0.042). No patients developed disease progression.
Gemcitabine is significantly inferior to BCG, but given its favourable toxicity profile, it may be useful for patients intolerant to or otherwise unable to receive BCG.

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Keywords

44 months
 
64 patients
 
adjuvant intravesical gemcitabine
 
bacillus Calmette-Guérin
 
baseline characteristics
 
cases
 
CIS
 
disease progression
 
favourable toxicity profile
 
gemcitabine
 
high-risk superficial bladder cancer
 
patients
 
patients intolerant
 
primary endpoint
 
progression rates
 
secondary endpoint
 
tolerability
 
two groups
 
unable