Phase 2 trial of pegylated liposomal doxorubicin in advanced endometrial cancer

Purpose. To evaluate the efficacy and toxicity of pegylated liposomal doxorubicin in patients with advanced endometrial cancer. Methods. Pegylated liposomal doxorubicin was administered at a dose of 40 mg/m(2), and repeated on an every 28-day schedule. Results. A total of 19 patients were enrolled in this phase 2 trial. Fourteen patients had received prior chemotherapy (carboplatin/paclitaxel-9; cisplatin/paclitaxel-3; single agent paclitaxel-2), seven prior radiation therapy, and three prior hormonal therapy. No patients had previously received doxorubicin. Two patients (11%) developed grade 1 hand-foot syndrome following treatment with pegylated liposomal doxorubicin. There were no episodes of cardiac dysfunction (>10% reduction in baseline ejection fraction). Three patients required hospitalization for nausea, vomiting, anemia, and dehydration. Only 2 (11%) patients required dose reduction. Four of 19 patients (21%; 95% CI: 3-39%) evaluable for response exhibited objective and subjective evidence of an antineoplastic effect of therapy (duration of responses: 2 months, 3 months, 4 months, 6+ months). Conclusion. The pegylated liposomal doxorubicin regimen employed in this trial exhibited an acceptable toxicity profile (cardiac dysfunction, hand-foot syndrome). Definite, although modest, antineoplastic activity in a patient population with recurrent or advanced endometrial cancer was documented.