A phase II trial of vinorelbine and pegylated liposomal doxorubicin in patients with pretreated metastatic breast cancer.

The objective of the present study is to investigate the clinical efficacy and tolerance of vinorelbine and pegylated liposomal doxorubicin (PLD) in patients with metastatic breast cancer (MBC) with prior taxane and/or anthracycline treatment. A total of 25 patients who previously received taxane- and/or anthracycline-based chemotherapy as first- and/or second-line treatment of MBC were entered into the study and were treated with 20 mg/m2 vinorelbine on day 1 and 8 and 30 mg/m2 PLD on day 1 every 3 weeks. All were evaluated for efficacy, quality of life, and tolerance. Three complete and 6 partial responses were observed in 25 patients for an objective response rate of 36% (95% confidence interval: 17-55%). Eight patients (32%) had stable disease of not less than 3 months and 8 patients (32%) had disease progression. The median progression-free survival was 6.7 months (range, 2-18 months), and the median overall survival was 13.2 months (range, 3-31 months). Severe toxicities (grade 3 or above) were neutropenia (16%) and mucositis (8%). The health-related quality of life assessed before each cycle by specific questionnaire did not differ significantly over the treatment period. The combination of vinorelbine and PLD for anthracycline- and/or taxane-pretreated patients with MBC is an active and safe regimen that does not compromise the quality of life.