Ifosfamide and vinorelbine as first-line chemotherapy for metastatic breast cancer

Purpose: To evaluate the efficacy and toxicity of the combination of ifosfamide (IFX) and vinorelbine (VNB) as first-line chemotherapy in metastatic breast cancer (MBC). Patients and Methods: Between August 1993 and August 1995, 45 patients with untreated MBC received a regimen that consisted of IFX 2 g/m(2) by 1-hour intravenous (IV) infusion on days 1 to 3, mesna 400 mg/m(2) by IV bolus at hours 0 and 4 and 800 mg/m(2) orally at hour 8 on days 1 to 3, and VNB 35 mg/m(2) by 20-minute IV infusion on days 1 and 15. Courses were repeated every 28 days. During the first course only, half-dose VNB (17.5 mg/m(2)) was administered on days 8 and 22. The median age was 53 years and 30 patients (67%) were postmenopausal. Dominant sites of disease were soft tissue in nine patients, bone in seven, and visceral in 29. Results: Objective responses (ORs) were recorded in 25 of 43 assessable patients (58%; 95% confidence interval, 43% to 73%). Complete remissions (CRs) occurred in six patients (14%) and partial remissions (PRs) in 19 (44%). No change (NC) was recorded in 10 patients (23%) and progressive disease (PD) in eight patients (19%). The median rime to treatment failure was 12 months and the median survival duration 19 months. Myelosuppression was the limiting toxicity, mainly leukopenia in 32 patients (74%). In contrast, anemia and thrombocytopenia were mild. Other significant toxicities included peripheral neuropathy in nine patients (21%), constipation in 15 (35%), and myalgias in 11 (26%). Conclusion: IFX/VNB is on active combination against MBC with moderate toxicity and deserves further evaluation. (C) 1996 by American Society of Clinical Oncology.