A study of pegylated liposomal Doxorubicin in platinum-refractory epithelial ovarian cancer.

OBJECTIVES

The purposes of this study were to determine the efficacy of pegylated liposomal doxorubicin (PLD), using a dose of 40 mg/m2 given every 3 weeks, in the treatment of platinum-refractory epithelial ovarian cancer (EOC) and to evaluate the toxicities.

METHODS

Fourteen patients with platinum-resistant EOC were treated with intravenous PLD 40 mg/m2 every 3 weeks. Tumor responses were assessed every 2-3 cycles by CT scan.

RESULTS

All 14 patients were evaluable for toxicity, but only 13 patients were evaluable for response because 1 patient who had grade 3 palmar-plantar erythrodysesthesia (PPE) refused to continue with the treatment. Three partial responses were observed in 13 patients. The overall response rate was 23% (95% confidence interval 10-38%). The median time to response was 2 months, and the median duration of response was 3 months. The median survival of the 13 patients was 14.5 months, and the median progression-free survival was 6 months. In this study, we had only 4 cases of grade 3 toxicity (2 cases of grade 3 leukopenia and 2 cases of grade 3 PPE). All toxicities that occurred were manageable.

CONCLUSION

This is the first report of the use of a slightly modified dose schedule for PLD at a dose of 40 mg/m2 every 3 weeks, which is active in platinum-refractory EOC with manageable toxicities.