PHASE-II TRIAL OF DOCETAXEL IN ADVANCED ANTHRACYCLINE-RESISTANT OR ANTHRACENEDIONE-RESISTANT BREAST-CANCER

Purpose: The purpose of this study was to evaluate the clinical effica cy and safety of docetaxel in patients with metastatic breast cancer ( MBC) resistant to doxorubicin or mitoxantrone. Patients and Methods: D ocetaxel 100 mg/m(2) was administered as a 1-hour intravenous (IV) inf usion every 3 weeks to 42 patients registered at four centers. Patient s must have received at least one but no more than two prior chemother apy regimens for MBC (in addition to any prior adjuvant therapy). One of the regimens for metastatic breast cancer must have included on ant hracycline or anthracenedione and the cancer must have progressed on t hat regimen. Results: Objective responses were seen in 20 of 35 assess able patients (three complete responses [CRs] and 17 partial responses [PRs]), for an objective response rate of 57% (95% confidence interva l [CI], 39% to 74%) and in 21 of 42 registered patients (50% response rate [RR]; 95% Cl, 34% to 66%) entered onto the trial. The median resp onse duration was 28 weeks. The most common toxicity in this study was grade 4 neutropenia, which occurred in 95% of patients. Other clinica lly significant nonhematologic side effects included stomatitis, skin reactions, neurosensory changes, asthenia, and fluid retention, Patien ts who received dexamethasone premedication had a later onset of fluid retention than those who did nor receive dexamethasone (onset at a me dian cumulative docetaxel dose of 503 mg/m(2) and 298 mg/m(2), respect ively). Conclusion: Docetaxel at this dose and schedule has a high lev el of antitumor activity in patients with treatment-refractory advance d breast cancer, and appears to be one of the most active agents for t he treatment of this patient population. (C) 1995 by American Society of Clinical Oncology.