Pegylated liposomal doxorubicin and carboplatin in malignant mixed epithelial mesenchymal and mesenchymal gynecologic tumors: A phase II trial of the AGO study group.

Abstract

5093 Background: There are only limited data on treatment options in patients with malignant mixed epithelial mesenchymal and mesenchymal gynecologic tumors. An internationally accepted treatment standard does not exist. Therefore, we conducted a prospective trial to determine the toxicity and efficacy of combination therapy with pegliposomal doxorubicin and carboplatin. Methods: Patients with advanced or recurrent gynecologic sarcomas were treated with pegylated liposomal doxorubicin 40mg/m² and carboplatin AUC 6, q28d over 6 cycles. The primary endpoint was PFS, secondary endpoints were tolerability and OS. Results: 40 patients were included in this study within 11 months: 20 pts with carcinosarcoma 14 pts with leiomyosarcoma and 6 pts with endometrial stromal sarcoma. The incidence of grade 3/4 hematologic toxicities was: anemia 17.5%, neutropenia 50%, and thrombocytopenia 22.5%. There were no febrile neutropenias. Grade 3/4 non-hematologic toxicities were: Elevation of GGT 5.0%, hypersensitivity 2.5%, and constipation 2.5%. Further toxicities of interest were: Grade 2 PPE and stomatitis in 10.0% each. The rate of CR/PR was 33.3%, CR/PR/SD was 70.4%. 12 months PFS and OS was 32.5% and 77.0%, respectively. Conclusions: The combination of pegylated liposomal doxorubicin and carboplatin is active in this indication. The safety profile seems to be favourable compared to other widely used combination therapies for these diseases.