Interindividual variability in pharmacokinetics may influence clinical outcomes of niraparib in patients with platinum-sensitive recurrent ovarian cancer (ROC). We aimed to investigate the pharmacokinetic-pharmacodynamic (PK-PD) relationship of niraparib in 49 patients with ROC from the multicenter phase IV NiQoLe study. Steady-state trough concentrations (C The starting dose was 200 mg/day in 39 patients (80%). Nineteen patients (39%) experienced early DLT. In multivariable analysis, the fourth quartile (Q4) of C Increased plasma exposure at D8 (C