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Journal of Clinical Oncology, Vol 18, Issue 17 (September), 2000: 3068-3077
© 2000 American Society for Clinical Oncology

RAPID PUBLICATION

Gemcitabine and Cisplatin Versus Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Advanced or Metastatic Bladder Cancer: Results of a Large, Randomized, Multinational, Multicenter, Phase III Study

By H. von der Maase, S.W. Hansen, J.T. Roberts, L. Dogliotti, T. Oliver, M.J. Moore, I. Bodrogi, P. Albers, A. Knuth, C.M. Lippert, P. Kerbrat, P. Sanchez Rovira, P. Wersall, S.P. Cleall, D.F. Roychowdhury, I. Tomlin, C.M. Visseren-Grul, P.F. Conte

From the Aarhus University Hospital, Aarhus; Herlev Hospital, University of Copenhagen, Herlev, Denmark; Northern Centre for Cancer Treatment, Newcastle General Hospital, Newcastle; St Bartholomews Hospital, London, United Kingdom; University of Torino, St Luigi Hospital, Orbassano; Santa Chiara Hospital, Pisa, Italy; The Princess Margaret Hospital, Toronto, Canada; National Institute of Oncology, Budapest, Hungary; Department of Urology, Bonn University, Bonn; Krankenhaus Nordwest, Frankfurt; Klinikum Ludwigshafen, Ludwigshafen, Germany; Centre Eugene Marquis, Rennes, France; Hospital Ciudad De Jaen, Jaen, Spain; Karolinska Hospital, Stockholm, Sweden; 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; email hvdm{at}oncology.dk

ABSTRACT

PURPOSE: Gemcitabine plus cisplatin (GC) and methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) were compared in patients with locally advanced or metastatic transitional-cell carcinoma (TCC) of the urothelium.

PATIENTS AND METHODS: Patients with stage IV TCC and no prior systemic chemotherapy were randomized to GC (gemcitabine 1,000 mg/m2 days 1, 8, and 15; cisplatin 70 mg/m2 day 2) or standard MVAC every 28 days for a maximum of six cycles.

RESULTS: Four hundred five patients were randomized (GC, n = 203; MVAC, n = 202). The groups were well-balanced with respect to prognostic factors. Overall survival was similar on both arms (hazards ratio [HR], 1.04; 95% confidence interval [CI], 0.82 to 1.32; P = .75), as were time to progressive disease (HR, 1.05; 95% CI, 0.85 to 1.30), time to treatment failure (HR, 0.89; 95% CI, 0.72 to 1.10), and response rate (GC, 49%; MVAC, 46%). More GC patients completed six cycles of therapy, with fewer dose adjustments. The toxic death rate was 1% on the GC arm and 3% on the MVAC arm. More GC than MVAC patients had grade 3/4 anemia (27% v 18%, respectively) and thrombocytopenia (57% v 21%, respectively). On both arms, the RBC transfusion rate was 13 of 100 cycles and grade 3/4 hemorrhage or hematuria was 2%; the platelet transfusion rate was four patients per 100 cycles and two patients per 100 cycles on GC and MVAC, respectively. More MVAC patients, compared with GC patients, had grade 3/4 neutropenia (82% v 71%, respectively), neutropenic fever (14% v 2%, respectively), neutropenic sepsis (12% v 1%, respectively), and grade 3/4 mucositis (22% v 1%, respectively) and alopecia (55% v 11%, respectively). Quality of life was maintained during treatment on both arms; however, more patients on GC fared better regarding weight, performance status, and fatigue.

CONCLUSION: GC provides a similar survival advantage to MVAC with a better safety profile and tolerability. This better-risk benefit ratio should change the standard of care for patients with locally advanced and metastatic TCC from MVAC to GC.




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