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

ObjectiveTo evaluate the efficacy of pegylated liposomal doxorubicin (PLD) and continuous infusion ifosfamide (IFO) in ovarian cancer patients who relapse within 1 year after first-line paclitaxel-platinum-based chemotherapy.MethodsPatients were stratified according to treatment-free interval (TFI) (< or ≥ 6 months). PLD (40 mg/m2, day 1), IFO (1700 mg/m2, infusion days 1–3), and mesna were given every 28 days 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.ResultsThere 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-foot 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.ConclusionThe 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 an alternative to platinum reintroduction and should be evaluated in a randomized trial.