Ifosfamide and vinorelbine in metastatic breast cancer in patients with prior anthracycline therapy

Objective: A prospective trial to evaluate the efficacy ana toxicity of ifo sfamide (IFX) and vinorelbine (VNB) in patients with prior anthracycline th erapy for metastatic breast cancer (MBC) was conducted. At the same time, t he scheduling of VNB in order to minimize toxicity of the combination was a lso evaluated. Patients and methods: Twenty-three patients with MBC who had already received initial chemotherapy with doxorubicin-containing regimens either as adjuvant or as first-line treatment in MBC were entered into the study. IFX 3 g/ m(2) and mesna 3 g/m(2) were given in divided doses over 2 days. In 4 patients, VNB was given 25 g/m(2) on days 1 and 3 in 3-h infusi on. In 8 patients, VNB was given on days 1 and 8 and in 5 patients VNB was given on days 1 and 15. Thirteen patients had received doxorubicin in adjuv ant setting, while 10 patients received doxorubicin as first-line treatment in metastatic disease. Dominant disease sites were soft tissues in 7 patie nts, visceral in 12 patients, and bone in 4 patients. The median age was 47 years. Results: Overall objective response was seen in 12/ 23 patients (52 .2%). Four patients achieved complete remission (CR), 8 patients achieved p artial remission (PR). The median duration of response was 9 months in resp onding patients, and the median overall survival duration was 15 months. Th e major dose-limiting toxicities were neutropenia grade III and IV in 8/17 patients and asthenia grade III and IV in 4 patients. Conclusion: IFX and V NB is an active combination. Neutropenia and asthenia were most significant when VNB was given on days 1 and 3. In the best-tolerated regimen, VNB was given on days 1 and 8.