Combination cisplatin-vinorelbine for relapsed and chemotherapy-pretreatedmetastatic breast cancer

The purpose of this study was to evaluate the combination of cisplatin and vinorelbine (PVn) for relapsed and chemotherapy-pretreated metastatic breas t cancer. Twenty-three patients with metastatic breast cancer and prior che motherapy were entered in a phase II study between June 1993 and December 1 994. Eleven patients were premenopausal and 12 were postmenopausal. Follow- up data up to June 1997 are presented. All patients received cisplatin at a dose of 90 mg/m(2) divided over 3 days as 30 mg/m(2) infused over 4 hours. Intravenous vinorelbine 25 mg/m(2) was given on days 1 and 8 or 15 accordi ng to patients' blood counts. Cycles were given every 3 to 3 weeks. An over all response rate of 61% (16/23 patients) was observed. Complete remission was obtained in six patients (26%) and partial remission was obtained in ni ne patients (35%). The duration of response ranged from 3 to 9 months, with an average of 4 months. Stable disease was noted in 29.1% and progressive disease in 8.3%. Overall survival at 12 months was 50%, and at 36 months it was 8%. Five of 12 patients (42%) who had prior doxorubicin therapy respon ded well to cisplatin-vinorelbine. Of those 12. seven were refractory and p rogressive on a doxorubicin-containing regimen, one had complete remission, and four had partial remission. Hematologic toxicity was acceptable. Treat ment was delayed because of neutropenia in nine cycles (9.2%) and grade 2 l eukopenia occurred in 54% of cycles. Febrile neutropenia occurred in seven cycles (7.1%), and five cycles were complicated by documented sepsis (5.1%) . No treatment-related mortality occurred. Thrombocytopenia (grade 3) was s een in 27% of cycles, with no patient having a platelet count below 50,000 or bleeding episodes. Other toxicities were not major or dose-limiting. In conclusion, the combination of cisplatin and vinorelbine produced good resp onses: 61% response rate (16 of 23 patients) in relapsed, refractory, and h eavily pretreated metastatic boast cancer, with 50% survival at 1 year, 12% at 2 years, and 8% at 3 years. In addition, a response rate of 42% (5 of 1 2 patients) was seen in patients resistant to anthracyclines.