1060 Background: The combination of doxorubicin and herceptin (H) has been proven to be an effective regimen in metastatic breast cancer (MBC), although it was associated with an increased risk of cardiotoxicity. Methods: The aim of this study was to evaluate cardiac safety and efficacy of epirubicin (E) in combination with low-dose herceptin (LD-H) as first-line chemotherapy for women with HER-2 positive MBC. Forty-five patients were enrolled in a two-step, multicenter phase II study. In the first step, H was given at 2 mg/Kg loading dose on day 1, followed by 1 mg/Kg weekly; in the second step (≥ 12 objective responses/21pts), H dose was maintained at 1 mg/kg weekly. E was administered at 90 mg/m2 on day 1 every 3 weeks. After 6–8 courses, H was continued as a single agent for a maximum of 52 weeks. To assess cardiotoxicity, patients were evaluated for the left ventricular ejection fraction (LVEF) at baseline, every two cycles during E and LD-H, and every three months during LD-H alone. Cardiotoxicity was defined as signs or symptoms of congestive heart failure in = 10% of patients at an E dose of 720 mg/ m2 or in = 20% of patients at an E dose > 720 < 1,000 mg/m2. Results: Eight episodes of cardiotoxicity were observed (an asymptomatic decrease in LVEF =15% in 6 patients and an asymptomatic decline of LVEF at = 50% in 2 patients). Grade 3–4 neutropenia, alopecia and thrombocytopenia occurred in 25%, 45.5% and 6.8% of patients, respectively. Complete and partial responses were 2.4 and 61.9%, respectively, for an overall response rate of 64.3%. The median time to progression was 8.2 months (95% CI, 5.2–9.2 months) and the median overall survival was 32.8 months (95% CI, 17.1–48.6 months). Conclusions: E plus LD-H is an active treatment regimen for HER-2 positive MBC and demonstrates a very favourable safety profile, with manageable cardiotoxicity. No significant financial relationships to disclose.
Gemcitabine and capecitabine in previously anthracycline-treated metastatic breast cancer: a multicenter phase II study (SOLTI 0301 trial)