1. ¹Medical Oncology C, National Cancer Institute, Via Mariano Semmola, 80131 Naples, Italy
2. ²Clinical Trials Unit, National Cancer Institute, Via Mariano Semmola, 80131 Naples, Italy
3. ³Senology, National Cancer Institute, Via Mariano Semmola, 80131 Naples, Italy
4. ⁴Pathology, National Cancer Institute, Via Mariano Semmola, 80131 Naples, Italy
5. ⁵Cell Biology and Preclinical Models, National Cancer Institute, Via Mariano Semmola, 80131 Naples, Italy
6. ⁶Medical Statistics, Second University, Naples, Italy

Correspondence: Dr F Perrone, E-mail: francesco.perrone@uosc.fondazionepascale.it

⁷For more details of members of NCI-Naples Breast Cancer Group see Appendix A1

Revised 3 January 2006; Accepted 16 March 2006; Published online 18 April 2006.

Abstract

The aim of the study was to demonstrate the superiority of docetaxel and epirubicin vs docetaxel alone as first-line therapy in metastatic breast cancer patients pretreated with adjuvant or neoadjuvant epirubicin. We compared single agent docetaxel 100 mg m^-2 (D) with the combination of docetaxel 80 mg m^-2 and epirubicin 75 mg m^-2 (ED). The response rate (72 vs 79%), the progression-free survival (median 9 vs 11 months) and the overall survival (median 18 vs 21 months) were not significantly different between the ED (n=26) and D arms (n=25), respectively. Leucopaenia, nausea and stomatitis were significantly worse with ED. In conclusion, epirubicin should not be administered in combination with taxanes in metastatic breast cancer patients relapsed after an anthracycline-based adjuvant or neoadjuvant therapy.