Phase II of doxorubicin/taxol in metastatic breast cancer

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Abstract
Purpose. To assess the response rate, survival, and toxicity of Taxol®(paclitaxel) as 1‐h infusion plus doxorubicin as first‐line treatment for patients with metastatic breast cancer (MBC). Patients and methods. Seventy‐six patients with untreated MBC were recruited. All of them had measurable disease and were evaluable for toxicity. Fifty‐five percent of the patients had visceral involvement. The dose of doxorubicin was fixed at 50 mg/m2 as a short intravenous infusion, followed by 200 mg/m2 of Taxol as a 1‐h intravenous infusion. Doxorubicin was administered during the first seven cycles, continuing with Taxol only up to a maximum of ten cycles. Results. Neutropenia was the most important toxicity: 30% grade 3 and 18% grade 4. Only 2 patients showed a decrease in the left ventricular ejection fraction (LVEF) which caused discontinuing the treatment. No clinical congestive 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 13.47± 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/m2 followed by Taxol 200 mg/m2 in 1‐h intravenous infusion presents a toxicity profile which demands a close follow‐up, it represents a convenient outpatient schedule with similar activity rate compared to longer Taxol infusions.