Phase I study of docetaxel in combination with cyclophosphamide as first-line chemotherapy for metastatic breast cancer.

Twelves, C. (2002) Phase I study of docetaxel in combination with cyclophosphamide as first-line chemotherapy for metastatic breast cancer. British Journal of Cancer, 87/10, pp. 1072-1078. (doi: 10.1038/sj.bjc.6600626)

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Abstract

This phase I was study conducted to establish the maximum tolerated dose, dose-limiting toxicity, and recommended dose of docetaxel in combination with cyclophosphamide as first-line chemotherapy for metastatic breast cancer. Twenty-six patients were treated with cyclophosphamide (600 mg m-2, intravenous bolus) followed by docetaxel (60, 75 or 85 mg m-2, 1-h intravenous infusion) every 3 weeks. The maximum tolerated dose was docetaxel 85 mg m-2 with cyclophosphamide 600 mg m-2, the dose-limiting toxicity being febrile neutropenia. Grade 4 neutropenia was experienced by all patients, but was generally brief. Otherwise, the combination was well tolerated with few acute and no chronic non-haematological toxicities of grade 3/4. Activity was observed at all dose levels and disease sites, and the overall response rate was 42% (95% confidence interval 22–61%). The pharmacokinetics of docetaxel were not modified by cyclophosphamide coadministration. These findings establish a recommended dose of docetaxel 75 mg m-2 in combination with cyclophosphamide 600 mg m-2 every three weeks for phase II evaluation.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:UNSPECIFIED
Authors: Twelves, C.
College/School:College of Medical Veterinary and Life Sciences
Journal Name:British Journal of Cancer

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