UROLOGICAL ONCOLOGY

Bacillus Calmette-Guerin versus chemotherapy for the intravesical treatment of patients with carcinoma in situ of the bladder: a meta-analysis of the published results of randomized clinical trials
Sylvester RJ, van der Meijden AP, Witjes JA, Kurth K
European Organization for the Research and Treatment of Cancer Data Center, Brussels, Belgium
J Urol. 2005; 174: 86-91; discussion 91-2

• Purpose: We determined the short-term and long-term efficacy of bacillus Calmette-Guerin (BCG) and chemotherapy in the treatment of patients with carcinoma in situ (CIS).
• Materials and Methods: A meta-analysis was performed on published results of randomized clinical trials comparing intravesical BCG to intravesical chemotherapy.
• Results: Nine randomized trials including 700 patients with CIS compared BCG to either mitomycin C (MMC), epirubicin, adriamycin, or sequential MMC/adriamycin. Of 298 patients on BCG 203 (68.1%) had a complete response compared with 158 of 307 patients on chemotherapy (51.5%), a reduction of 47% in the odds of nonresponse on BCG (OR 0.53, p = 0.0002). Based on a median followup of 3.6 years, 161 of 345 patients on BCG (46.7%) had no evidence of disease compared with 93 of 355 patients on chemotherapy (26.2%), a reduction of 59% in the odds of treatment failure on BCG (OR 0.41, p < 0.0001). Although the long-term benefit of BCG was smaller in trials with MMC, BCG was superior to MMC in trials with maintenance BCG (OR 0.57, p = 0.04). The reduction of 26% in the risk of progression on BCG (p = 0.20) is consistent with the reduction of 27% (p = 0.001) previously reported in a larger superficial bladder cancer meta-analysis.
• Conclusions: Intravesical BCG significantly reduces the risk of short and long-term treatment failure compared with intravesical chemotherapy. Therefore, it is considered to be the intravesical agent of choice in the treatment of CIS.
  
  
• Editorial Comment
  Sylvester and coworkers from the EORTC present another extraordinary paper on patients outcomes with superficial bladder cancer. This metaanalytic calculation of all published data on intravesical treatment of CIS reveals that chemotherapy is clearly inferior to immunotherapy with BCG with regard to recurrence, and, more importantly, with regard to progression.
  Clearly, these high-risk patients deserve maintenance BCG therapy. If recurrence, or worse, progression occurs while under maintenance therapy, immediate radical cystectomy is justified.

Dr. Andreas Bohle
Professor of Urology
HELIOS Agnes Karll Hospital
Bad Schwartau, Germany