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


METHODS
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.
Porena
Massimo
M
Section of Urology and Andrology, Department of Medical-Surgical Specialties and Public Health, University of Perugia, Perugia, Italy.
Del Zingaro
Michele
M
Lazzeri
Massimo
M
Mearini
Luigi
L
Giannantoni
Antonella
A
Bini
Vittorio
V
Costantini
Elisabetta
E
D000283:Administration, Intravesical; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D004724:Endoscopy / Q000379:methods; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D012008:Recurrence; D015203:Reproducibility of Results; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000628:therapy*; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D001500:BCG Vaccine; D003841:Deoxycytidine; D000093542:Gemcitabine