Docetaxel ; Anthracycline ; Breast neoplasm ; Metastasis
Abstract
PURPOSE: Tbis phase II study was performed to evaluate the efficacy and safety of docetaxel0ain patients with anthracycline-pretreated metastatic breast cancer (MBC).0aMATERIALS AND METHODS: From September 1996 to January 1998, 27 patients with metastatic0abreast cancer from 31 to 63 years of age with a performance status of 0 to 2 were registered0ain the phase II trial. All patients had metastatic breast cancer which had progressed or0arelapsed 2 during or after treatment with an anthracycline-based regimen. Docetaxel 75 mg/m20awas ad- ministered over 1 hour every 21 days until disease progression was documented or0auntil toxic effects precluded further therapy. All patients received dexamethasone orally0aat the dose of 16 mg on days -1, 0, 1 of each cycle. 0aRESULTS: Objective responses were seen in 9 of 25 assessable patients (two complete and seven0apartial responses), with an overall objective response rale of 36%. The median duration of0aresponse was 36 weeks (range 19.0~40.5). The median time to progression and survival duration0awere 17.5 and 69 weeks, respectively, for assessable patients. One hundred fifty cycles0a(median, five) of docetaxel were administered. Among 27 patients assessable for toxicity,0athe following side effects were reported: nadir neutropenia grade 3 (4 patients) and0agrade 4 (22 patients); grade 2 stomatitis (6 patients); grade 2 alopecia (5 patients);0agrade 2 to 3 neurosensory toxicity (4 patients); no hypersensitivity reaction; mild fluid0aretention (4 patients). 0aCONCLUSION: Docetaxel is an active agent in patients with antracycline-pretreated metastatic0abreast cancer. Docetaxel was associated with severe but reversible neutropenia. Dexamethasone0aprevented hypersensitivity reactions and appeared to ameliorate fluid retention.