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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

From the Aristotle University of Thessaloniki Medical School, Thessaloniki; University of Athens Medical School, Center of Biostatistics, University of Athens School of Nursing, Medical Center, "Agii Anargyri" Cancer Hospital, "Ippokration" Hospital, and "Hygeia" Medical Center, Athens; "Metaxa" Cancer Hospital, Piraeous; University of Patras Medical School, Patras; and University of Ioannina Medical School, Ioannina, Greece.

Address reprint requests to George Fountzilas, MD, First Department of Internal Medicine, Section of Medical Oncology, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Macedonia, Greece; email: fountzil{at}med.auth.gr

PURPOSE: To compare the efficacy of two different schedules of epirubicin and paclitaxel, as first-line chemotherapy, in patients with advanced breast cancer (ABC).

PATIENTS AND METHODS: From October 1997 until May 1999, 183 eligible patients with ABC entered the study. Chemotherapy in group A (93 patients) consisted of four cycles of epirubicin at a dose of 110 mg/m² followed by four cycles of paclitaxel at a dose of 225 mg/m² in a 3-hour infusion. All cycles were repeated every 2 weeks with granulocyte colony-stimulating factor support. The therapeutic regimen in group B (90 patients) consisted of epirubicin (80 mg/m²) immediately followed by paclitaxel (175 mg/m² in a 3-hour infusion) every 3 weeks for six cycles.

RESULTS: In total, 79 patients (85%) in group A and 72 patients (80%) in group 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 groups 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 the overall response rate between the two groups (55% v 42%, P = .10). Severe neutropenia was more frequently observed with concurrent treatment. After a median follow-up of 16.5 months, median time to progression was 10 months in group A and 8.5 months in group B (P = .27), and median survival was 21.5 and 20 months, respectively (P = .17).

CONCLUSION: The present study failed to demonstrate a significant difference in overall response rate between dose-dense sequential administration of epirubicin and paclitaxel compared with the combination of the two drugs given on the same day, even though the sequential treatment resulted in a significantly higher complete response rate.

Presented in part at the Twenty-Fifth European Society of Medical Oncology Congress, Hamburg, Germany, October 13-17, 2000.

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