733 Real world data of niraparib in platinum sensitive relapsed ovarian cancer: a multicenter experience of the MITO group

Introduction/Background PARP (poly adenosine diphosphate ADP-ribose polymerase) inhibitors are approved as maintenance therapy in platinum sensitive ovarian cancer (OC), in first line and in the recurrent setting, regardless of BRCA mutational status. Real-world data after the introduction of these agents are needed to evaluate whether the benefit observed in phase III randomized clinical trials can be translated into clinical practice. The aim of our study was to provide real-life data on efficacy and safety of niraparib administered as maintenance in platinum sensitive relapsed OC patients (PSROC). Methodology This observational study included relapsed OC patients that received niraparib as maintenance, at the time of platinum sensitive recurrence within the Italian expanded-access program. Objectives of the study was to describe efficacy of niraparib in a real-world setting in terms of PFS and OS in the overall population and in BRCA mutated and BRCA wild type cohort of patients, as well safety, describing incidence of adverse events (AEs). Results Among 304 eligible patients, 260 (85%) had BRCA wild-type tumor and 36 (11.9%) were BRCA mutated. Median PFS was 9.1 months (95% CI: 6.9 – 11.2) and 10.3 months (95% CI: 7.0 – 13.5) in the BRCAwt and BRCAmut cohorts, respectively. Furthermore, median OS was 41.7 months (95% CI: 31.6 – 41.9) and 34.6 months (95% CI: N.E.) in the BRCAwt and BRCAmut cohorts, respectively. Most frequently reported Grade 3 or 4 hematologic events were thrombocytopenia (33.1%), anemia (25.0%), and neutropenia (12.5%). Other grade 3–4 non hematologic events were nausea (5.9%), skin toxicity (1.2%) and fatigue (1.2%). There were no myelodysplastic syndrome or acute myeloid leukemia reported. Most of the hematologic laboratory abnormalities occurred within the first five treatment cycles. Conclusion Data from this large real-life dataset suggested that maintenance with niraparib in the real-life setting of platinum sensitive OC recurrence is effective and well tolerated. Disclosures The authors have nothing to declare.