© 2006 European Society for Medical Oncology
symposium article |
Long-term survival results of a randomized trial comparing gemcitabine/cisplatin and methotrexate/vinblastine/doxorubicin/cisplatin in patients with locally advanced and metastatic bladder cancer
1 Department of Oncology, Aarhus University Hospital, Denmark; 2 Department of Oncology, Herlev University Hospital, Denmark; 3 Northern Centre for Cancer Treatment, Newcastle General Hospital, UK; 4 Santa Chiara Hospital, Italy; 5 University of Torino, St. Luigi Hospital, Orbassano, Italy; 6 St. Bartholomew's Hospital, UK; 7 The Princess Margaret Hospital, Canada; 8 Eli Lilly and Company, IN, USA
* Correspondence to: Dr J. T. Roberts, Northern Centre for Cancer Treatment, Westgate Road, Newcastle upon Tyne, NE4 6BE UK. Tel: +44 191 256 3543; E-mail: trevor.roberts{at}nuth.nhs.uk
Purpose: To compare long-term survival in patients with locally advanced and metastatic transitional cell carcinoma (TCC) of the urothelium treated with gemcitabine plus cisplatin (GC) or methotrexate/vinblastine/doxorubicin/cisplatin (MVAC).
Patients and methods: Efficacy data from a large randomized phase III study of GC versus MVAC were updated. Time-to-event analyses were performed on the observed distributions of overall survival time and progression-free survival.
Results: Four hundred and five patients were randomized, 203 to the GC arm and 202 to the MVAC arm. At the time of this analysis, 347 patients have died (GC 176, MVAC 171). Overall survival was similar in both arms (HR 1.09; 95% confidence interval [CI] 0.88–1.34, P = 0.66) with a median survival of 14.0 months (95% CI 12.3–15.5 months) in the GC, and 15.2 months (95% CI 13.2–17.3 months) in the MVAC arm. The median progression-free survival was 7.7 months with GC (95% CI 6.8–8.8) and 8.3 months with MVAC (95% CI 7.3–9.7) with a HR of 1.09 (95% CI 0.89–1.34). Significant prognostic factors favoring overall survival included performance status (>70), TNM staging (M0 vs. M1), low/normal alkaline phosphatase expression, number of sites of disease <3, and the absence of visceral metastasis. By adjusting for these prognostic factors, the HR was 0.99 for overall survival and 1.01 for progression-free survival.
Conclusions: Long-term overall and progression-free survival following treatment with GC or MVAC are similar. These results strengthen the role of GC as a standard of care in patients with locally advanced and metastatic transitional-cell carcinoma (TCC).
Key words: gemcitabine, cisplatin, bladder cancer, survival
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