575 Epidemiology of ovarian cancer in kazakhstan (2013–2018)

Abstract

randomised 2:1 to receive FSD of niraparib 300 mg orally once daily (QD) or placebo. The trial was amended to incorporate an ISD of 200 mg orally QD for patients with a body weight <77 kg or platelet count <150,000/mL, and 300 mg QD in patients with a body weight 77 kg and platelet count 150,000/mL. Patients were stratified by best response to firstline chemotherapy (complete/partial response), receipt of neoadjuvant chemotherapy (yes/no), and homologous recombination status (deficient/proficient and not determined). BRCA status was determined in tumour samples at screening via the myChoice test (Myriad ® ). The post hoc BRCAm subgroup PFS analysis was performed using a stratified Cox proportional hazards model and Kaplan-Meier methodology. Safety and patient-reported outcome analyses were also performed. Results The intention-to-treat population comprised 733 randomised patients, of which 223 (30%) had BRCAm tumours. Of those, 144 (65%) received FSD and 79 (35%) received ISD. Niraparib provided a comparable PFS benefit over placebo in patients receiving both FSD (hazard ratio, 0.44; 95% CI 0.26-0.73) and ISD (hazard ratio 0.29; 95% CI 0.13-0.67). A PFS subgroup analysis by patient characteristics is shown in table 1. A summary of grade 3 selected adverse events is shown in table 2. Conclusion Niraparib significantly improved PFS when utilised as maintenance treatment after front-line therapy in patients with BRCAm aOC. Patients receiving FSD or ISD derived similar PFS benefit, while the ISD group showed an improved safety profile. Disclosures Dr.