23rd Annual Congress of the European Association of Urology in Milan (Italy) from 26-29 March 2008

The EAU Scientific Committee has selected the abstract mentioned below for Prize of the Congress President for the best presentation on clinical urology.

“Long-term efficacy results of EORTC GU group study 30911 comparing epirubicin, bacillus calmette-guerin (BCG), and BCG plus isoniazid in patients with intermediate and high risk stage Ta T1 papillary carcinoma of the bladder".

in Oral Session 14 entitled: Management of superficial bladder tumours II.

R. Sylvester, M. Brausi, W. Hoeltl, P. Powell, P. Whelan, T. Gorlia and T. de Reijke

 

Introduction and Objectives

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.

 

Material and Methods

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.

 

Results

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 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.

 

Conclusions

In patients with intermediate and high risk stage Ta and T1 bladder cancer, 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 however that the benefit of BCG is not limited to just high risk patients, but rather that intermediate risk patients also benefit from BCG.