Association of Pegylated Liposomal Doxorubicin (pld) and Ifosfamide (ifo) in Early Recurrent Ovarian Cancer Patients: A Multicenter Phase Ii Trial.

5043 Background: A majority of advanced ovarian cancer relapse within one year after first line platinum-based chemotherapy. Methods: From March 2003 to October 2004, 97 patients who early relapsed (≤ 12 months) after platinum and taxane first line chemotherapy were enrolled in a phase II, multicenter study to evaluate the efficacy of the association of PD and IFO. The primary end point was objective response rate. Patients were stratified by treatment free interval (TFI) (< or ≥ 6 months). PLD (40 mg/m2, day 1) and IFO plus mesna (1700 mg/m2, continuous infusion, days 1–3), were given every 28 days, for 6 to 9 cycles. Response was assessed according to RECIST (measurable disease) or Rustin criteria (non measurable disease). Results: By November 2004, 84 patients were evaluable for response and toxicity. Initial characteristics were: median age 60 yrs (31 to 77), WHO PS≤1 96%, serous histology 79%, TFI<6 months 60%, measurable disease 46%. The median number of cycles was 4 (1 to 9). Chemotherapy was delayed because of toxicity in 10%. Among the 376 administered cycles, grade 3–4 anemia, thrombocytopenia and neutropenia occurred in 3%, 1% and 55%, respectively. Febrile neutropenia was observed in 6% of all the courses. Growth factors, erythropoietin, red blood cell and platelets transfusions were administered in 13%, 9%, 5% and 1% of courses. Other grade 3–4 toxicities were uncommon: nausea/vomiting 5%, hand-foot syndrom 1%, stomatitis 1%. One grade 3 encephalopathy was observed but no cardiologic toxicity. No toxic death was observed. The objective response rate (CR and PR) was 39%. Median overall survival was 8.4 months (1 to 43). Conclusions: IFO and PLD is a safe association. Our findings suggest a potential advantage of the addition of IFO to PLD compared to single agent therapy in patients who early failed first line chemotherapy for advanced ovarian cancer. No significant financial relationships to disclose.