IFOSFAMIDE AND VINORELBINE AS FIRST-LINE CHEMOTHERAPY FOR METASTATIC BREAST-CANCER

Purpose: To evaluate the efficacy and toxicity of the combination of i fosfamide (IFX) and vinorelbine (VNB) as first-line chemotherapy in me tastatic breast cancer (MBC). Patients and Methods: Between August 199 3 and August 1995, 45 patients with untreated MBC received a regimen t hat consisted of IFX 2 g/m(2) by 1-hour intravenous (IV) infusion on d ays 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. Dur ing the first course only, half-dose VNB (17.5 mg/m(2)) was administer ed 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 ni ne patients, bone in seven, and visceral in 29. Results: Objective res ponses (ORs) were recorded in 25 of 43 assessable patients (58%; 95% c onfidence interval, 43% to 73%). Complete remissions (CRs) occurred in six patients (14%) and partial remissions (PRs) in 19 (44%). No chang e (NC) was recorded in 10 patients (23%) and progressive disease (PD) in eight patients (19%). The median rime to treatment failure was 12 m onths and the median survival duration 19 months. Myelosuppression was the limiting toxicity, mainly leukopenia in 32 patients (74%). In con trast, anemia and thrombocytopenia were mild. Other significant toxici ties included peripheral neuropathy in nine patients (21%), constipati on in 15 (35%), and myalgias in 11 (26%). Conclusion: IFX/VNB is on ac tive combination against MBC with moderate toxicity and deserves furth er evaluation. (C) 1996 by American Society of Clinical Oncology.