Weekly gemcitabine and cisplatin combination therapy in patients with transitional cell carcinoma of the urothelium: a phase II clinical trial.
OBJECTIVE
To determine the efficacy of gemcitabine and cisplatin combination therapy in patients with advanced and/or metastatic transitional cell urothelial carcinoma.


METHODS
Forty-two chemonaïve patients with Karnofsky performance status (KPS) > or = 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.
von der Maase
H
H
Department of Oncology, Aarhus University Hospital, Norrebrogade, Denmark.
Andersen
L
L
Crinò
L
L
Weinknecht
S
S
Dogliotti
L
L
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D014571:Urologic Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine