biostudies-literatureUnknown10(5)Quesada SGSK<h4>Background</h4>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.<h4>Materials and methods</h4>Steady-state trough concentrations (C_min,ss) on days 8 (D8) and 90 (D90) after treatment initiation were analyzed in the PK-PD analysis in regard to early dose-limiting toxicity (DLT) during the first 3 months of treatment, self-reported adverse events [Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)], and progression-free survival (PFS). Logistic regression and CoESMO open105054https://www.ebi.ac.uk/biostudies/studies/S-EPMC12018549biostudies-literatureExposure-response relationship of niraparib in maintenance therapy for recurrent ovarian cancer: ancillary analysis of the French GINECO-NiQoLe study.PMC12018549Fabbro MGrellety TLe Roux DFournel PJouinot ABlanchet BCombe PLebreton CJoly FEmambux SBrachet PEHardy-Bessard ACThomas RFollana PPuszkiel AQuesada SKalbacher EAlexandre JSelle FMille DSpaeth DfalseExposure-response relationship of niraparib in maintenance therapy for recurrent ovarian cancer: ancillary analysis of the French GINECO-NiQoLe study.<h4>Background</h4>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.<h4>Materials and methods</h4>Steady-state trough concentrations (C_min,ss) on days 8 (D8) and 90 (D90) after treatment initiation were analyzed in the PK-PD analysis in regard to early dose-limiting toxicity (DLT) during the first 3 months of treatment, self-reported adverse events [Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)], and progression-free survival (PFS). Logistic regression and Co2025-01-01T00:00:00Z2025 Apr2025-07-06T03:04:23.485Z2025-07-06T03:04:23.485ZS-EPMC120185494022045010.1016/j.esmoop.2025.105054