Aims and background: We conducted a feasibility study to determine the safety and efficacy of liposome-encapsulated doxorubicin (Myocet) and vinorelbine in previously treated metastatic breast cancer patients.
Patients and methods: Liposome-encapsulated doxorubicin (30 mg/m2) plus vinorelbine (25 mg/m2) on days 1 and 8, every 3 weeks were given until disease progression, sever toxicity or up to 9 cycles. All patients underwent tumor assessment before enrollment. Patients with a life expectancy longer than 3 months and measurable or assessable disease were eligible.
Results: Twenty-one patients were included. Median number of treatment cycles was 5 (range, 3-9). No complete response was obtained. Stable disease and/or partial response was obtained in 9 patients. Fifteen patients experienced grade 3-4 leukopenia. There was no significant decline in cardiac function. Non-hematological toxicity was tolerable (grade 1-2).
Conclusions: The association of doxorubicin and vinorelbine has been shown to be feasible in previously treated advanced breast cancer patients. Its efficacy should be tested as first-line therapy in metastatic patients with cardiac co-morbidities.