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Trilaciclib dosage in Chinese patients with extensive-stage small cell lung cancer: a pooled pharmacometrics analysis
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Trilaciclib dosage in Chinese patients with extensive-stage small cell lung cancer: a pooled pharmacometrics analysis
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Journal Article
Trilaciclib dosage in Chinese patients with extensive-stage small cell lung cancer: a pooled pharmacometrics analysis
2024
Overview
This study aimed to analyze potential ethnic disparities in the dose–exposure–response relationships of trilaciclib, a first-in-class intravenous cyclin-dependent kinase 4/6 inhibitor for treating chemotherapy-induced myelosuppression in patients with extensive-stage small cell lung cancer (ES-SCLC). This investigation focused on characterizing these relationships in both Chinese and non-Chinese patients to further refine the dosing regimen for trilaciclib in Chinese patients with ES-SCLC. Population pharmacokinetic (PopPK) and exposure–response (E–R) analyses were conducted using pooled data from four randomized phase 2/3 trials involving Chinese and non-Chinese patients with ES-SCLC. PopPK analysis revealed that trilaciclib clearance in Chinese patients was approximately 17% higher than that in non-Chinese patients with ES-SCLC. Sex and body surface area influenced trilaciclib pharmacokinetics in both populations but did not exert a significant clinical impact. E–R analysis demonstrated that trilaciclib exposure increased with a dosage escalation from 200 to 280 mg/m
2
, without notable changes in myeloprotective or antitumor efficacy. However, the incidence of infusion site reactions, headaches, and phlebitis/thrombophlebitis rose with increasing trilaciclib exposure in both Chinese and non-Chinese patients with ES-SCLC. These findings suggest no substantial ethnic disparities in the dose–exposure–response relationship between Chinese and non-Chinese patients. They support the adoption of a 240-mg/m
2
intravenous 3-day or 5-day dosing regimen for trilaciclib in Chinese patients with ES-SCLC.
Publisher
Springer Nature Singapore,Nature Publishing Group
Subject
/ Antineoplastic Agents - administration & dosage
/ Antineoplastic Agents - adverse effects
/ Antineoplastic Agents - pharmacokinetics
/ Antineoplastic Agents - therapeutic use
/ Biomedical and Life Sciences
/ Dosage
/ Dose-Response Relationship, Drug
/ Female
/ Humans
/ Kinases
/ Lung Neoplasms - drug therapy
/ Male
/ Patients
/ Protein Kinase Inhibitors - administration & dosage
/ Protein Kinase Inhibitors - pharmacokinetics
/ Protein Kinase Inhibitors - therapeutic use
/ Pyrroles
/ Randomized Controlled Trials as Topic
/ Small Cell Lung Carcinoma - drug therapy
/ Small Cell Lung Carcinoma - pathology
/ Triazoles - administration & dosage
/ Triazoles - pharmacokinetics
/ Vaccine
