Association of pegylated liposomal doxorubicin and ifosfamide in early recurrent ovarian cancer patients: A Multicenter Phase II Trial

Objective. To evaluate the efficacy of pegylated liposomal doxorubicin (PLD) and continuous infusion ifosfamide (IFO) in ovarian cancer patients who relapse within I year after first-line paclitaxel-platinum-based chemotherapy. Methods. Patients were stratified according to treatment-free interval (TFI) (<or >= 6 months). PLD (40 mg/m(2), day I), IFO ( 1700 mg/m(2), infusion clays 1-3), and mesna were given every 28 Clays for 6-9 cycles. Primary endpoint was objective response rate (ORR). Secondary endpoints were response duration, progression free survival (PFS), overall survival (OS), and toxicity. Results. There Were 98 evaluable patients (58%, TFI<6 months). Median number of cycles was 5 (range: 1-9). The frequency of grade 3/4 anemia, thrombocytopenia, and neutropenia was 7%, 3%, and 48%, respectively; febrile neutropenia was 3%. A low rate Of grade 3/4 non-hematologic toxicities was reported, including nausea/vomiting (3/4%), hand-foct syndrome (2%), and mucositis (2%). The ORR was 28% (41% and 19% in patients with TFI >= 6, or <6 months, respectively); rate of disease stabilization was 26%; response duration and median OS were 6 (2.4-26) and 14 (1-46) months, respectively. Conclusion. The combination of PLD and continuous IFO is a feasible and efficient treatment in patients with relapsed ovarian cancer, especially with TFI between 6 and 12 months. This regimen may represent all alternative to platinum reintroduction and should be evaluated in a randomized trial. (C) 2009 Elsevier Inc. All rights reserved.