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Long-Term Survival Results of a Randomized Trial Comparing Gemcitabine Plus Cisplatin, With Methotrexate, Vinblastine, Doxorubicin, Plus Cisplatin in Patients With Bladder Cancer

From the Department of Oncology, Aarhus University Hospital, Aarhus; Department of Oncology, Herlev University Hospital, Herlev, Denmark; Northern Centre for Cancer Treatment, Newcastle General Hospital, Newcastle; St Bartholomew’s Hospital, London, United Kingdom; Santa Chiara Hospital; University of Torino, Torino, St Luigi Hospital, Orbassano, Italy; The Princess Margaret Hospital, Toronto, Ontario, Canada; and Eli Lilly and Company, Indianapolis, IN

Address reprint requests to Hans von der Maase, MD, DMSc, Department of Oncology, Aarhus University Hospital, DK-8000 Aarhus C, Denmark; e-mail: maase{at}as.aaa.dk

PURPOSE: To compare long-term survival in patients with locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium treated with gemcitabine/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 and progression-free survival.

RESULTS: A total of 405 patients were randomly assigned: 203 to the GC arm and 202 to the MVAC arm. At the time of analysis, 347 patients had died (GC arm, 176 patients; MVAC arm, 171 patients). Overall survival was similar in both arms (hazard ratio [HR], 1.09; 95% CI, 0.88 to 1.34; P = .66) with a median survival of 14.0 months for GC and 15.2 months for MVAC. The 5-year overall survival rates were 13.0% and 15.3%, respectively (P = .53). The median progression-free survival was 7.7 months for GC and 8.3 months for MVAC, with an HR of 1.09. The 5-year progression-free survival rates were 9.8% and 11.3%, respectively (P = .63). Significant prognostic factors favoring overall survival included performance score (> 70), TNM staging (M0 v M1), low/normal alkaline phosphatase level, number of disease sites ( three), and the absence of visceral metastases. By adjusting for these prognostic factors, the HR was 0.99 for overall survival and 1.01 for progression-free survival. The 5-year overall survival rates for patients with and without visceral metastases were 6.8% and 20.9%, respectively.

CONCLUSION: Long-term overall and progression-free survival after treatment with GC or MVAC are similar. These results strengthen the role of GC as a standard of care in patients with locally advanced or metastatic TCC.

Supported by a grant from Eli Lilly and Company.

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

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