Pegylated liposomal doxorubicin and vinorelbine in metastatic breast cancer: Final results of a phase II trial.

e11050 Background: Pegylated liposomal doxorubicin (PLD) has demonstrated equivalent antitumor activity to conventional doxorubicin and a significantly lower risk of cardiotoxicity when given as single agent or in combination with cyclophosphamide, but there is limited experience with the combination of PLD and vinorelbine. This phase II study was performed to evaluate the efficacy and safety of the PLD and vinorelbine in patients with metastatic breast cancer. Methods: From August 2004 to August 2007, 51 patients with metastatic breast cancer were treated with PLD (35 mg/m2) and vinorelbine (25 mg/m2 D1, 8) in 3-weeks intervals for up to eight cycles. Results: The overall response rate was 50% and 78% of patients derived a clinical benefit. Median time to progression and overall survival were 10.0 months (95% CI, 6.9-13.1 months) and 25 months (95% CI, 22.1-29.8 months), respectively. Median duration of response was 12.0 months (95% CI 7.1-16.9). A total of 408 courses were evaluable for toxicity: grade 3 and 4 neutropaenia affected 14 patients and 3 patients, respectively. Grade 3 and 4 palmar-plantar erythrodysesthesia syndrome was documented in five cases and one case, whereas grade 3 and 4 mucositis occurred in six cases and two cases, respectively. Grade 2 cardiac toxicity was observed in only one case. Conclusions: The combination of pegylated liposomal doxorubicin and vinorelbine is an active and well-tolerated regimen in patients with metastatic breast cancer. No significant financial relationships to disclose.