Phase II Study of Pegylated Liposomal Doxorubicin and Carboplatin in Patients With Platinum-Sensitive and Partially Platinum-Sensitive Metastatic Ovarian Cancer

作者：Rapoport B L^*; Vorobiof D A; Slabber C; Alberts A S; Hlophe H S; Mohammed C

来源：International Journal of Gynecological Cancer, 2009, 19(6): 1137-1141.

DOI：10.1111/IGC.0b013e3181a8b938

• Ovarian neoplasms
• Pegylated liposomal doxorubicin
• Doxorubicin
• Carboplatin

Objective: This phase If study assessed the activity and safety of pegylated liposomal doxorubicin (PLD) plus carboplatin in relapsed ovarian cancer (ROC).
Method: Forty women with platinum-sensitive and partially platinum-sensitive ROC were treated with PLD 50 mg/m(2) plus carboplatin area under the Curve 5 every 28 days in this South African multicenter Study. All patients who completed 3 cycles of chemotherapy were evaluated for response. Primary outcome was response in the intent-to-treat population.
Results: Complete response was 35%, and partial response was 32.5% (overall response, 67.5%). Median time-to-progression was 11.9 months, and median Survival was 30.0 months. Overall response was higher in platinum-sensitive (81%) versus partially platinum-sensitive patients (53%), as were median duration of response, median time-to-progression, and median survival. Treatment was well tolerated, with no grade 4 nonhematologic toxicities. Grade 3/4 hematologic toxicities included leukopenia (58%), neutropenia (55%). and thrombocytopenia (43%).
Conclusion: Pegylated liposomal doxorubicin Plus carboplatin is well tolerated and active in the treatment of platinum-sensitive and partially platinum-sensitive ROC.

• 出版日期2009-8