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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

Lookup NU author(s): Dr James Roberts


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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).

Publication metadata

Author(s): Roberts JT, von der Maase H, Sengelov L, Conte PF, Dogliotti L, Oliver T, Moore MJ, Zimmermann A, Arning M

Publication type: Conference Proceedings (inc. Abstract)

Publication status: Published

Conference Name: Annals of Oncology: Workshop on Gemcitabine - Ten Years of Clinical Experience

Year of Conference: 2006

Pages: V118-V122

ISSN: 0923-7534

Publisher: Oxford University Press


DOI: 10.1093/annonc/mdj965

Library holdings: Search Newcastle University Library for this item

ISBN: 15698041


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