Phase II of doxorubicin taxol in metastatic breast cancer

Purpose. To assess the response rate, survival, and toxicity of Taxol(R)(pa clitaxel) as 1-h infusion plus doxorubicin as first-line treatment for pati ents with metastatic breast cancer (MBC). Patients and methods. Seventy-six patients with untreated MBC were recruite d. All of them had measurable disease and were evaluable for toxicity. Fift y-five percent of the patients had visceral involvement. The dose of doxoru bicin was fixed at 50 mg/m(2) as a short intravenous infusion, followed by 200 mg/m(2) of Taxol as a 1-h intravenous infusion. Doxorubicin was adminis tered during the first seven cycles, continuing with Taxol only up to a max imum of ten cycles. Results. Neutropenia was the most important toxicity: 30% grade 3 and 18% g rade 4. Only 2 patients showed a decrease in the left ventricular ejection fraction (LVEF) which caused discontinuing the treatment. No clinical conge stive heart failure (CHF) was observed. Seventy-four patients were eligible for response evaluation: 10 (14%) achieved complete response (CR) and 46 ( 62%) achieved partial response (PR). The mean duration of response was 13.4 7 +/- 1.35 months (95% confidence interval (CI): 10.82; 16.12) and the mean survival was 21.50 +/- 1.42 months (95% CI: 18.72; 24.29). Conclusion. The overall response (OR) rate was 76%. No CHF was assessed and 2 patients stopped treatment due to LVEF decrease. Although doxorubicin 50 mg/m(2) followed by Taxol 200 mg/m(2) in 1-h intravenous infusion presents a toxicity profile which demands a close follow-up, it represents a conven ient outpatient schedule with similar activity rate compared to longer Taxo l infusions.