Journal of Clinical Oncology, Vol 16, 3392-3397, Copyright © 1998 by American Society of Clinical Oncology
Docetaxel and cisplatin in metastatic urothelial cancer: a phase II study
L Sengelov, C Kamby, B Lund and SA Engelholm
Department of Oncology, Herlev University Hospital, Denmark. lisa.sengelov@dadlnet.dk
PURPOSE: Docetaxel and cisplatin has documented single-agent activity and
different toxicity profiles in patients with metastatic urothelial cancer.
We performed a phase II study in which docetaxel was combined with
cisplatin to evaluate response rate, toxicity, and survival. PATIENTS AND
METHODS: Eligibility criteria included performance status (World Health
Organization [WHO]) less than 3; normal bone marrow, liver, and renal
function; and no concurrent malignancy or symptomatic peripheral
neuropathy. Docetaxel (Taxotere; Rhone-Poulenc Rorer, Paris, France) 75
mg/m2 was combined with cisplatin 75 mg/m2 every third week. Patients
received premedication with prednisolone and clemastine. RESULTS: A total
of 25 patients were assessable for response and toxicity. Median age was 64
years; five patients had locoregional disease only and 20 had metastatic
disease. Response was achieved in 15 patients (60%; 95% confidence interval
[CI], 39% to 79%), including seven patients (26%) who achieved a complete
response. Overall median survival time was 13.6 months (range, 1.5 to
26.4+). The most frequent toxicity was nausea and vomiting (80% of
patients). Neutropenia grade 3 or 4 was observed in 56% of patients, but
only one had febrile neutropenia. Mucositis and diarrhea were encountered
in 13% of cycles, mostly grade 1 or 2. Peripheral neuropathy and skin
changes grade 1 and 2 were observed in 76% and 36%, respectively. Fluid
retention and hypersensitivity reactions were infrequent and mild.
CONCLUSION: The combination of docetaxel and cisplatin is effective and
feasible in patients with metastatic urothelial cancer with a manageable
safety profile.
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