Single-agent gemcitabine is active in previously treated metastatic breastcancer

Background This phase Il study was designed to assess the efficacy and safe ty of gemcitabine in patients with metastatic breast cancer (MBC) previousl y treated with an anthracycline- or anthracenedione-containing regimen as f irst-line therapy for metastatic disease. Patients and Methods: Forty-seven patients with MBC were enrolled in five French centers. Patients were elig ible if they had received one prior chemotherapy regimen with an anthracycl ine or anthracenedione for metastatic disease, if they had responded to tha t prior regimen, and if they had relapsed at least 6 months after the first response. Fifteen patients received more than one prior anthracycline regi men; thus, gemcitabine was third-line therapy for 30% of patients. Gemcitab ine 1,200 mg/m(2) was administered as a 30-min intravenous infusion on days 1,8, and 15 of a 28-day cycle for a maximum of eight cycles after the best response was obtained. Results: Objective responses were seen in 12 of 41 assessable patients (4 complete responses and 8 partial responses), for an objective response rate of 29% (95% confidence interval, 16-46%). The media n response duration was 8.1 months (range: 2.5-27.4 months). Serious hemato logical toxicity was minimal, with grade 4 neutropenia in 2% of the patient s (no neutropenic fever), grade 3 neutropenia in 28% of the patients, and g rade 3 thrombocytopenia in 6% of the patients. Among the nonhematological t oxicities, asthenia was the most common. Conclusions: Gemcitabine given at this dose and schedule is a well-tolerated treatment with definitive antitu mor activity in pretreated MBC patients. This result warrants future explor ation of the use of gemcitabine as a single agent and in combination in pat ients with MBC. Copyright (C) 2001 S. Karger AG, Basel.