Originally published as JCO Early Release 10.1200/JCO.2005.11.094 on June 6 2005

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Adjuvant Cisplatin Plus Methotrexate Versus Methotrexate, Vinblastine, Epirubicin, and Cisplatin in Locally Advanced Bladder Cancer: Results of a Randomized, Multicenter, Phase III Trial (AUO-AB 05/95)

From the Trial Group AB 05/95 "Arbeitsgemeinschaft Urologische Onkologie" of the German Cancer Society; and Division of Biostatistics, Central Institute of Mental Health Mannheim/University of Heidelberg, Heidelberg, Germany

Address reprint requests to Jan Lehmann, MD, Department of Urology and Pediatric Urology, Saarland University, 66421 Homburg/Saar, Germany; e-mail: jan.lehmann{at}uniklinikum-saarland.de

PURPOSE: Radical cystectomy as standard treatment of muscle-invasive urothelial carcinoma of the urinary bladder cures less than 50% of patients with locally advanced bladder cancer. We compared two adjuvant combination chemotherapies in patients with stage pT3a-4a and/or pathologic node-positive transitional-cell carcinoma of the bladder after radical cystectomy.

PATIENTS AND METHODS: A total of 327 patients were randomly assigned to either adjuvant systemic chemotherapy with three cycles of cisplatin 70 mg/qm² on day 1 and methotrexate 40 mg/qm² on days 8 and 15 of a 21-day cycle (CM) or three cycles of methotrexate 30 mg/qm² on days 1, 15, and 22, vinblastine 3 mg/qm² on days 2, 15, and 22, epirubicin 45 mg/qm² on day 2, and cisplatin 70 mg/qm² on day 2 of a 28-day cycle (M-VEC).

RESULTS: The hazard ratio for progression-free survival as the primary end point was 1.13 (90% CI, 0.86 to 1.48) for 163 CM patients compared with 164 M-VEC patients whose right-hand limit remained below the upper bound compatible with the noninferiority hypothesis ( = .0403). The 5-year progression-free, tumor-specific, and overall survival rates (point estimates ± SE) for CM versus M-VEC were 46.3% ± 4.6% v 48.8% ± 4.5%, 52.0% ± 4.6% v 52.3% ± 4.8%, and 46.1% ± 4.3% v 45.1% ± 4.6%, respectively. WHO grade 3 and 4 leukopenia occurred in 7.0% of patients treated with CM and 22.2% of patients treated with M-VEC (P < .0001).

CONCLUSION: CM cannot be considered inferior to M-VEC with regard to progression-free survival of patients with locally advanced bladder cancer after radical cystectomy. Moreover, patients receiving adjuvant CM combination therapy experienced significantly less grade 3 and 4 leukopenia than patients treated with M-VEC.

Supported in part by the Gunther-Voges Gesellschaft and Stiftung Berliner Bank, Germany (neither sponsor had any influence on study design or on the collection, analysis, or interpretation of data; and neither had any influence in the writing of the report or the decision to submit the manuscript for publication).

Presented at the following meetings: 54th Congress of the German Society of Urology in Wiesbaden, Germany, September 18-21, 2002; XVIIIth Congress of the European Association of Urology in Madrid, Spain, March 12-15, 2003; 98th Annual Meeting of the American Urological Association Chicago, IL, April 26-May 1, 2003; and the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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