Comparing Epirubicin, Bacillus Calmette-Guerin (BCG), & BCG + Isoniazid In Patients With Intermediate & High Risk Stage Ta T1 Bladder Carcinoma

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology
Article Date: 20 Jun 2008 - 4:00 PDT

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ORLANDO, FL (UroToday.com) - Intravesical chemotherapy and intravesical BCG both reduce the recurrence rate in patients with stage Ta, T1 bladder cancer, however the benefit of BCG relative to chemotherapy for long-term endpoints, especially in intermediate risk patients, is still controversial. The objective is to compare after transurethral resection (TUR) the long-term efficacy of 6 weekly intravesical instillations of epirubicin, bacillus Calmette-Guerin (BCG) and BCG plus isoniazid followed by 3 weekly maintenance instillations at months 3, 6, 12, 18, 24, 30 and 36 in patients with intermediate and high risk stage Ta T1 papillary bladder cancer.

From January 1992 to February 1997, a total of 957 patients were randomized after TUR but prior to confirmation of histological stage and grade in EORTC Genito-Urinary Group phase III trial 30911. Patients with carcinoma in situ were ineligible.

837 eligible patients were included in the analysis, 298 (36%) were T1 and 102 (12%) were grade 3. With a median duration of follow-up of 9.2 years, the time to first recurrence (p<0.0001), time to distant metastases (p=0.046), overall (p=0.02) and disease specific survival (p=0.03) were all significantly longer in the 2 BCG arms as compared to epirubicin, however there was no difference with respect to the time to progression to muscle invasive disease. There was no difference in efficacy between the 2 BCG arms for any of the endpoints considered. 323 patients (39%) with stage T1 or grade 3 tumors were considered to be high risk and 497 patients (60%) were classified as intermediate risk. There was a consistent trend towards a greater benefit of BCG relative to epirubicin in the intermediate risk group patients than in the high risk group patients for all endpoints.

They conclude that in patients with intermediate and high risk stage Ta-T1 bladder cancer, this trial confirms the superiority of intravesical BCG with or without isoniazid as compared to intravesical epirubicin not only for time to first recurrence, but also for the long-term endpoints of time to distant metastases, overall and disease specific survival.. This study shows however that the benefit of BCG is not limited to just high risk patients, but rather that intermediate risk patients also benefit from BCG.

Presented by Richard Sylvester, MD, Maurizio Brausi, MD, Wolfgang Hoeltl, MD, Philip Powell, MD, Peter Whelan, MD, Thierry Gorlia, MD, Theo De Reijke, MD, at the Annual Meeting of the American Urological Association (AUA) - May 17 - 22, 2008. Orange County Convention Center - Orlando, Florida, USA.

Reported by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

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