Exposure-response relationship of niraparib in maintenance therapy for recurrent ovarian cancer: ancillary analysis of the French GINECO-NiQoLe study.

ABSTRACT:

Background

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.

Materials and methods

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 Co

SUBMITTER: Quesada S 

PROVIDER: S-EPMC12018549 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature