Abstract:
Background: Liposomal cisplatin (lipoplatin) has a mechanism of action similar to that of cisplatin, with reduced toxicities and enhanced or similar efficacy. We wanted to assess the efficacy and safety of a lipoplatin- vinorelbine combination in a phase II clinical trial in metastatic breast cancer (MBC). Methods: Thirty-five patients with HER-2-neunegative (HER-2-neu) MBC were enrolled. Lipoplatin 120 mg-m2 (days 1, 8, and 15) and vinorelbine 30 mg-m2 (days 1 and 8) were administered in a 21-day cycle. Results: Thirty-five patients were included in the intent-to-treat (ITT) analysis; 32 patients were evaluable for response. The objective response rate was 53.1percent. Complete response (CR) was achieved in 3 patients (9.4percent), partial response (PR) was seen in 14 patients (43.8percent), stable disease (SD) was obtained in 12 patients (37.5percent), and progressive disease (PD) was seen in 3 patients (9.4percent). Median time to disease progression was 8 months (range 6-10 months). After a median follow-up of 15.5 months, 18 patients were still alive; the median survival time was 22 months (95percent confidence interval [CI], 14-30). A total of 174 cycles were administered. Neutropenia was the most frequent hematologic toxicity, with grade 3-4 neutropenia observed in 44percent of cycles. Febrile neutropenia was observed in 4 patients (11.4percent). No grade 3-4 nephrotoxicity or neuropathy was noted. Grade 1-2 nephrotoxicity occurred in 8 patients (22.9percent) and grade 3 vomiting was seen in 3 patients (8.6percent). Conclusions: The results of this trial reveal that vinorelbine-lipoplatin is effective in treating patients with MBC. This regimen is well tolerated with no grade 3-4 nephrotoxicity or neuropathy. The investigation of this regimen as first-line treatment in MBC is warranted. © 2011 Elsevier Inc. All rights reserved.