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First-Line Treatment With Epirubicin and Vinorelbine in Metastatic Breast Cancer

From the Division of Medical Oncology B, Biostatistic Unit, Regina Elena Institute for Cancer Research, Rome; Oncologic Scientific Institute, Bari; Oncologic Center, Catania; Clinical Oncology, Policlinic University, Palermo; Oncologic Unit, SS Annunziata Hospital, Taranto; and Oncologic Day Hospital, G. Panico Hospital, Tricase (Lecce), Italy.

Address reprint requests to Patrizia Vici, MD, Division of Medical Oncology B, Regina Elena Institute for Cancer Research, Via E. Chianesi, 53, 00144 Rome, Italy; email: lopez{at}ifo.it

PURPOSE: This phase II multicenter trial was aimed at investigating the activity of epirubicin-vinorelbine combination as first-line chemotherapy in metastatic breast cancer patients.

PATIENTS AND METHODS: Ninety-seven patients with metastatic breast cancer and no prior exposure to anthracyclines received the following regimen: epirubicin 100 mg/m² by intravenous (IV) bolus infusion on day 1 plus vinorelbine 25 mg/m² by 30-minute IV infusion on days 1 and 5, every 3 weeks for up to eight cycles. All patients also received granulocyte colony-stimulating factor (G- CSF) on days 7 to 12 of every cycle.

RESULTS: Objective responses, confirmed at least 4 weeks after the first documentation, were observed in 65 out of 92 assessable patients (70.6%; 95% CI, 62% to 80%). Disease remained stable in 17 patients (18.5%). Responses were observed in all disease sites, being 94% in soft tissue, 60% in bone, and 66% in visceral disease. Median time to response, median duration of response, median time to progression, and median overall survival were 2, 9, 10, and 26 months, respectively. The dose-limiting toxicity was neutropenia, which was grade 4 in 36% of the patients, and was accompanied by fever in 26% of the cases. Grade 3 to 4 mucositis was encountered in 28% of the patients. Other toxicities were mild to moderate. No cardiotoxicity was observed.

CONCLUSION: The epirubicin-vinorelbine combination with G-CSF support has been shown in this study to be highly active as first-line treatment of metastatic breast cancer patients, with significant although transient toxicity. This justifies further evaluation in the neoadjuvant setting and in early-stage breast cancer.

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