Dose-dense sequential chemotherapy with epirubicin and paclitaxel in advanced breast cancer

The purpose of this study was to evaluate the activity and toxicity profile of dose-dense sequential chemotherapy with epirubicin (EPI) and paclitaxel in advanced breast cancer (ABC). From January to September 1997, 41 patients with recurrent or metastatic (s tage IV) breast cancer were enrolled in the study. Their media age was 57(r ange, 33-77) years and median performance status 0 (range, 0-2). Twenty pat ients had received adjuvant chemotherapy. The chemotherapeutic regimen cons isted of 4 cycles of EPI 110 mg/m(2) every 2 weeks followed by 4 cycles of paclitaxel, 225 mg/m(2) over 3 hours every 2 weeks. G-CSF was administered prophylactically on days 2-10 of each cycle. 34 (83.0%) patients completed all 8 cycles of chemotherapy. A total of 304 cycles were administered, 259 (85.0%) of them at full dose. Thirty (10.0%) cycles were delivered with a delay. The relative median dose intensities of EPI and paclitaxel were 0.95. Most common grade 3-4 side effects were anem ia (15.0%) neutropenia (7.5%), and alopecia (90.0%). Overall, 8 (19.5%) pat ients achieved a complete and 15 (36.5%) a partial response. Median duratio n of response was 8.4 (range, 3.1-15.5+) months. After a median follow-up o f 18.5 months, median time to progression was 8.7 (range, 0.5-21+) months; median survival has not been reached yet. Dose-dense sequential chemotherapy with EPI and paclitaxel shows promising activity as first-line treatment in ABC. Randomized studies comparing this type of chemotherapy with the classical administration of the two drugs tog ether every 3 weeks are ongoing.