Pegylated Liposomal Doxorubicin and Carboplatin in Late-relapsing Ovarian Cancer: A GINECO Group Phase II Trial

Background: The GINECO group previously demonstrated that pegylated liposomal doxorubicin (PLD)- carboplatin combination was an effective and well-tolerated treatment for advanced ovarian cancer (AOC) patients in late relapse. The purpose of the present analysis was to confirm these results in a prospective cohort of late-relapsing AOC patients. Patients and Methods: Eighty-one consecutive patients received PLD 30 mg/m 2 , followed by carboplatin (area under the curve) 5 mg min/ml, every 28 days for 6 courses or until progression. Results: The objective response (OR) rate was 65.4% . The median progression-free survival (PFS) and overall survival (OS) were 13.6 months and 38.9 months, respectively. Haematological toxicities were more common than non-haematological toxicities. Non- hematologic adverse reactions were moderate and grade 3 palmar-plantar erythrodysesthesia was limited to one patient. No cardiotoxicity was observed and no toxic death occurred. Conclusion: These data support the clinical efficacy and tolerability of PLD in combination with carboplatin as second-line therapy for AOC patients in late relapse.