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Lehmann, Jan; Retz, Margitta; Wiemers, Christina; Beck, Joachim; Thüroff, Joachim; Weining, Christoph; Albers, Peter; Frohneberg, Detlef; Becker, Tanja; Funke, Peter-Jörg; Walz, Peter; Langbein, Sigrun; Reiher, Frank; Schiller, Matthias; Miller, Kurt; Roth, Stephan; Kälble, Tilman; Sternberg, Donald; Wellek, Stefan; Stöckle, Michael

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)

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  • Media type: E-Article
  • Title: 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)
  • Contributor: Lehmann, Jan; Retz, Margitta; Wiemers, Christina; Beck, Joachim; Thüroff, Joachim; Weining, Christoph; Albers, Peter; Frohneberg, Detlef; Becker, Tanja; Funke, Peter-Jörg; Walz, Peter; Langbein, Sigrun; Reiher, Frank; Schiller, Matthias; Miller, Kurt; Roth, Stephan; Kälble, Tilman; Sternberg, Donald; Wellek, Stefan; Stöckle, Michael
  • Published: American Society of Clinical Oncology (ASCO), 2005
  • Published in: Journal of Clinical Oncology, 23 (2005) 22, Seite 4963-4974
  • Language: English
  • DOI: 10.1200/jco.2005.11.094
  • ISSN: 0732-183X; 1527-7755
  • Origination:
  • Footnote:
  • Description: 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 (α = .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.
  • Access State: Open Access