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Cited by 441

The DOI matches its Crossref record; 14 of the 14 references it cites were found in a registry or an index.

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

Open access
Sylvester, Richard J., Brausi, Maurizio A., Kirkels, Wim J., Hoeltl, Wolfgang, Calais Da Silva, Fernando, Powell, Philip H., Prescott, Stephen, Kirkali, Ziya, van de Beek, Cees, Gorlia, Thierry, de Reijke, Theo M.·2010·European Urology

Abstract

Background Intravesical chemotherapy and bacillus Calmette-Guérin (BCG) reduce the recurrence rate in patients with stage Ta T1 urothelial bladder cancer; however, the benefit of BCG relative to chemotherapy for long-term end points is controversial, especially in intermediate-risk patients. Objective The aim of the study was to compare the long-term efficacy of BCG and epirubicin. Design, setting, and participants From January 1992 to February 1997, 957 patients with intermediate- or high-risk stage Ta T1 urothelial bladder cancer were randomized after transurethral resection to one of three treatment groups in the European Organization for Research and Treatment of Cancer Genito-Urinary Group phase 3 trial 30911. Intervention Patients received six weekly instillations of epirubicin, BCG, or BCG plus isoniazid (INH) followed by three weekly maintenance instillations at months 3, 6, 12, 18, 24, 30, and 36. Measurements End points were time to recurrence, progression, distant metastases, overall survival, and disease-specific survival. Results and limitations With 837 eligible patients and a median follow-up of 9.2 yr, time to first recurrence (p < 0.001), distant metastases (p = 0.046), overall survival (p = 0.023), and disease-specific survival (p = 0.026) were significantly longer in the two BCG arms combined as compared with epirubicin; however, there was no difference for progression. Three hundred twenty-three patients with stage T1 or grade 3 tumors were high risk, and the remaining 497 patients were intermediate risk. The observed treatment benefit was at least as large, if not larger, in the intermediate-risk patients compared with the high-risk patients. Conclusions In patients with intermediate- and high-risk stage Ta and T1 urothelial bladder cancer, intravesical BCG with or without INH is superior to intravesical epirubicin not only for time to first recurrence but also for time to distant metastases, overall survival, and disease-specific survival. The benefit of BCG is not limited to just high-risk patients; intermediate-risk patients also benefit from BCG.

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Metadata

Authors
Sylvester, R. J., Brausi, M. A., Kirkels, W. J., Hoeltl, W., Calais Da Silva, F., Powell, P. H., Prescott, S., Kirkali, Z., van de Beek, C., Gorlia, T., & de Reijke, T. M.
Venue
European Urology
Publisher
Elsevier BV
Published
2010-05
Volume
57
Issue
5
Pages
766-773
ISSN
0302-2838 (ISSN-L)
OpenAlex
W2108974158
Cited by
441
References
14
FWCI
17.22
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: 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. https://app.cochat.ai/papers/10.1016/j.eururo.2009.12.024
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Sylvester, R. J., Brausi, M. A., Kirkels, W. J., Hoeltl, W., Calais Da Silva, F., Powell, P. H., Prescott, S., Kirkali, Z., van de Beek, C., Gorlia, T., & de Reijke, T. M. (2010). 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. European Urology. https://doi.org/10.1016/j.eururo.2009.12.024

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