Evaluation of Pegylated Liposomal Doxorubicin in the Treatment Of Both Platinum- and Paclitaxel-Refractory Epithelial Ovarian Cancer

Pegylated liposomal doxorubicin (PLD) is a stealth liposomal form of doxorubicin that has been approved for the treatment of patients with relapsed ovarian cancer. Previous studies have shown a response rate of about 25% in patients who had treatment failure with prior platinum- and/or paclitaxel-based regimens. Our purpose was to determine the anti-tumor activity of PLD in Asian patients with both platinum- and paclitaxel- refractory epithelial ovarian cancer, and to evaluate the toxicity of this drug in these heavily pretreated patients. Between January 2000 and December 2003, 18 patients with documented relapsed disease, who had had prior treatment with both platinum- and paclitaxel-based regimens within 6 months, were enrolled. They were treated with PLD 40 mg/m 2 intravenous infusion every 4 weeks. Anti-tumor responses and adverse effects were evaluated based on WHO criteria and Common Toxicity Criteria, respectively. All 18 patients were assessable for response and toxicity. Five patients (27.8%) experienced a response (3 complete responses, 2 partial responses), four patients (22.2%) had stable disease, while nine patients (50.0%) had progressive disease. The median progression-free survival was 14 weeks. Median overall survival was 48 weeks. There was no grade 3 or 4 leukopenia or thrombocytopenia. Non-hematologic toxicities included grade 2 hand-foot syndrome in one patient and grade 1 stomatitis in three patients. Two patients experienced severe skin pigmentation. There was no treatment delay due to toxicity. PLD at a dose of 40 mg/m 2 every 4 weeks was generally well tolerated and effective, even for a heavily pretreated Asian population. These results may provide some information for further clinical trials integrating PLD with front-line therapy.