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Annals of Oncology 10:1461-1465, 1999
© 1999 European Society for Medical Oncology

research-article

Weekly gemcitabine and cisplatin combination therapy in patients with transitional cell carcinoma of the urothelium: A phase II clinical trial

H. von der Maase1,, L. Andersen1, L. Crinò2, S. Weinknecht3 and L. Dogliotti4

1Department of Oncology, Aarhus University Hospital Norrebrogade, Aarhus C, Denmark
2Ospedale Policlinico Perugia, Italy
3Abteilung für Urologie Berlin, Germany
4Medical Oncology, San Luigi University Hospital Orbassano, Torino, Italy

Correspondence to: Prof. H. von der Maase, MD, Department of Oncology, Aarhus University Hospital, Norrebrogade, DK-8000 Aarhus C, Denmark

Purpose: To determine the efficacy of gemcitabine and cisplatin combination therapy in patients with advanced and/or meta-static transitional cell urothelial carcinoma.

Patients and methods: Forty-two chemonaïve patients with Karnofsky performance status (KPS) ≥ 70 were treated with cisplatin 35 mg/m2 followed by gemcitabine 1000 mg/m2 (30 min i.v. infusion) on days 1, 8, and 15 every twenty-eight days.

Results: Thirty-eight patients were evaluable for efficacy. Half had visceral disease. There were seven complete (18%) and nine partial responses (24%), for a response rate of 42% (95% confidence interval (95% CI): 26%–59%). Responses were independently reviewed. Median response duration was 13.5 months (95% CI: 8.5–18.1 months), median time to progressive disease 7.2 months (95% CI: 4.0–9.1 months) and median survival 12.5 months (95% CI: 8.1–18.7 months); one-year survival was 52%. Laboratory toxicities included leucopenia (44% grade 3; 17% grade 4), neutropenia (25% grade 3; 33% grade 4) and thrombocytopenia (29% grade 3; 49% grade 4). Four patients had grade 4 symptomatic toxicity (three nausea and vomiting, one diarrhoea). There were no grade 4 infections and no toxic deaths.

Conclusions: The combination of gemcitabine and cisplatin is active in patients with locally advanced and/or metastatic urothelial carcinoma. The weekly schedule of cisplatin is considered inappropriate.

bladder cancer, gemcitabine–cisplatin combination, phase II study, transitional cell carcinoma


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