High efficacy of paclitaxel and doxorubicin as first-line therapy in advanced breast cancer: a phase I-II study.

The aim of this study was to define the maximum tolerated dose (MTD) of paclitaxel (TAX) in combination with doxorubicin (ADM). To evaluate the efficacy and tolerability of this combination, TAX was administered in escalating doses of 30 mg/m(2), starting from 120 mg/m(2), by 1 hour continuous infusion, per group of three patients; ADM was administered at a fixed dose of 50 mg/m(2) 24 hours before administering TAX (phase I). The combination was recycled every 3 weeks. In phase II, TAX was administered at the MTD defined in phase I. Thirty-six women were enrolled. The MTD of TAX was 220 mg/m(2). Objective responses were observed in 28/34 (82%) assessable patients. The median progression-free survival was 11.8 months and overall survival 27.8 months. The main clinical toxicity was neutropenia (grade III-IV) of short duration (94%). Two patients developed cardiac toxicity. The combination TAX+ADM is very effective in advanced breast cancer.