Management Of Superficial Bladder Tumors: Group Study Comparing Epirubicin, Bacillus Calmette-Guerin (BCG), And BCG Plus Isoniazid

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 13 Apr 2008 - 0:00 PDT

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UroToday.com - Long-term efficacy results of EORTC GU group study 30911 comparing epirubicin, bacilus calmetteguerin (BCG), and BCG plus isoniazid in patients with intermediate and high risk stage Ta T1 papillary carcinoma of the bladder

Dr. Sylvester from the EORTC presented a study on the benefit of BCG relative to chemotherapy for long term endpoints, primarily in intermediate risk patients. They compared the long-term efficacy of 6 weekly intravesical instillations of epirubicin, bacillus Calmette-Guerin (BCG) and BCG plus isoniazid after transurethral resection (TUR) 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.

Between 1992 and 1997, 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. A final total of 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 = 0.03), overall (p = 0.02) and disease specific survival (p = 0.03) were all significantly longer in the two 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 two 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.

This trial confirms the superiority of intravesical BCG with or without isoniazid as compared to intravesical epirubicin not only for the time to first recurrence, but also for the long-term endpoints of time to distant metastases, overall and disease specific survival. This study shows 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: R.J. Sylvester, MD, et al at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

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

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