Integrated exposure-response analysis of efficacy and safety of lurbinectedin to support the dose regimen in small-cell lung cancer.

ABSTRACT:

Purpose

These exposure-response (E-R) analyses integrated lurbinectedin effects on key efficacy and safety variables in relapsed SCLC to determine the adequacy of the dose regimen of 3.2 mg/m² 1-h intravenous infusion every 3 weeks (q3wk).

Methods

Logistic models and Cox regression analyses were applied to correlate lurbinectedin exposure metrics (AUC_tot and AUC_u) with efficacy and safety endpoints: objective response rate (ORR) and overall survival (OS) in SCLC patients (n = 99) treated in study B-005 with 3.2 mg/m² q3wk, and incidence of grade 4 (G4) neutropenia and grade 3-4 (G ≥ 3) thrombocytopenia in a pool of cancer patients from single-agent phase I to III studies (n = 692) treated at a wide range of doses. A clinical utilit

SUBMITTER: Fernandez-Teruel C 

PROVIDER: S-EPMC9054899 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature