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

Abstract

OBJECTIVE:

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.

METHOD:

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).

RESULTS:

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.

CONCLUSIONS:

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.

• Authors: Massimo Porena, Michele Del Zingaro, Massimo Lazzeri, Luigi Mearini, Antonella Giannantoni, Vittorio Bini, Elisabetta Costantini
• Journal: Urologia internationalis (Urol Int) Vol. 84 Issue 1 Pg. 23-7 ( 2010) ISSN: 1423-0399 [Electronic] Switzerland
• PMID: 20173364 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright 2010 S. Karger AG, Basel.

Chemical References

• Antineoplastic Agents
• BCG Vaccine
• Deoxycytidine
• Gemcitabine

Topics

• Administration, Intravesical
• Antineoplastic Agents (therapeutic use)
• BCG Vaccine (therapeutic use)
• Deoxycytidine (analogs & derivatives, therapeutic use)
• Disease Progression
• Endoscopy (methods)
• Humans
• Immunotherapy (methods)
• Recurrence
• Reproducibility of Results
• Treatment Outcome
• Urinary Bladder Neoplasms (therapy)
• Gemcitabine