Dose-dense sequential chemotherapy with epirubicin and paclitaxel versus the combination, as first-line chemotherapy, in advanced breast cancer: A randomized study conducted by the Hellenic Cooperative Oncology Group

Purpose: To compare the efficacy of two different schedules of epirubicin a nd paclitaxel, as first-line chemotherapy, in patients with advanced breast cancer (nsc). Patients and Methods: From October 1997 until May 1999, 183 eligible patien ts with ABC entered the study. Chemotherapy in group A (93 patients) consis ted of four cycles of epirubicin at a dose of 110 mg/m(2) followed by four cycles of paclitaxel at a dose of 225 mg/m2 in a 3-hour infusion. All cycle s were repeated every 2 weeks with granulocyte colony-stimulating factor su pport. The therapeutic regimen in group B (90 patients) consisted of epirub icin (80 mg/m(2)) immediately followed by paclitaxel (175 mg/m(2) in a 3-ho ur infusion) every 3 weeks for six cycles. Results: In total, 79 patients (85%) in group A and 72 patients (80%) in gr oup B completed treatment. The median relative dose-intensity of epirubicin was 0.96 in both groups, and that of paclitaxel was 0.96 and 0.97 in group s A and B, respectively. The complete response rate was higher in group A ( 21.5% v 9% P = .02). Nevertheless, there was no significant difference in t he overall response rate between the two groups (55% v 42%, P = .10). Sever e neutropenia was more frequently observed with concurrent treatment. After a median follow-vp of 16.5 months, median time to progression was 10 month s in group A and 8.5 months in group B (P = .27), and median survival was 2 1.5 and 20 months, respectively (P = .17). Conclusion: The present study failed to demonstrate a significant differenc e in overall response rate between dose-dense sequential administration of epirubicin and paclitaxel compared with the combination of the two drugs gi ven on the same day, even though the sequential treatment resulted in a sig nificantly higher complete response rate. (C) 2001 by American Society of C linical Oncology.