Results of EORTC Genito-Urinary Group phase III trial 30911

In patients with stage Ta T1 urothelial bladder cancer, intravesical chemotherapy and bacillus Calmette-Guérin (BCG) both reduce the recurrence rate, but the benefit of BCG relative to chemotherapy for long term endpoints is controversial, especially in intermediate risk patients.

The European Association of Urology guidelines for non–muscle-invasive urothelial carcinoma of the bladder recommend adjuvant treatment for patients following transurethral resection based on their risk of recurrence and progression to muscle invasive disease. It recommends one immediate instillation of chemotherapy as the complete adjuvant treatment for patients at low risk of recurrence and progression, at least 1 yr of intravesical BCG after an immediate instillation of chemotherapy for patients at high risk of progression, and either further instillations of chemotherapy or a minimum of 1 yr of BCG after an immediate instillation of chemotherapy for intermediate-risk patients.

EORTC phase III trial 30911 has shown that for patients with intermediate- and high-risk stage Ta and T1 bladder cancer, intravesical BCG with or without isoniazid is superior to intravesical epirubicin for the time to first recurrence ( p < 0.001),  and for the long-term end points of time to distant metastases ( p = 0.046), overall survival ( p = 0.023), and disease-specific survival ( p = 0.026).[1] The observed treatment benefit was at least as large, if not larger, for the intermediate-risk patients compared with the high-risk patients. No difference was observed between the arms with regards to time to progression. The study included 837 eligible patients with stage Ta T1 urothelial carcinoma of the bladder, 323 high risk and 497 intermediate risk patients, with a median follow-up of 9.2 years.

This trial confirms the superiority of intravesical BCG with or without isoniazid as compared with intravesical epirubicin for time to first recurrence, overall survival, and disease specific survival for high risk patients and also for intermediate risk patients.

 John Bean and Richard Sylvester


[1] R. J. SYLVESTER, M.A. BRAUSI, W.J. KIRKELS, W. HOETL, F.C. DA SILVA, P.H. POWELL, S. PRESCOTT, Z. KIRKALI, C. VAN DE BEEK, T. GORLIA, T.M. DE REIJKE, EORTC Genito-Urinary Tract Cancer Group European Urology. Long-Term Efficacy Results of EORTC Genito-Urinary Group Randomized Phase 3 Study 30911 Comparing Intravesical Instillations of Epirubicin, Bacillus Calmette-Guérin, and Bacillus Calmette-Guérin plus Isoniazid in Patients with Intermediate- and High-Risk Stage Ta T1 Urothelial Carcinoma of the Bladder DOI: 10.1016/j.eururo.2009.12.

Back to news list