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Purpose <p>Osimertinib displays substantial inter-individual variability in both pharmacokinetics and pharmacodynamics. This study aimed to explore the exposure-response relationship of osimertinib, thereby to provide a basis for personalized therapeutic strategies.</p> Methods <p>We systematically searched PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, Wanfang Database, and China Biology Medicine Literature Database separately through October 2024, with no study type restrictions. The Newcastle-Ottawa Scale was used for quality assessment, and data were extracted and recorded using Excel software.&#xa0;The meta-analysis was conducted using Stata software.</p> Results <p>A total of nine observational studies were included. Among them, five studies identified a correlation between steady-state trough concentration and progression-free survival, with three specifically demonstrating that the low steady-state trough concentration group had longer progression-free survival. One study observed a negative correlation between clearance and overall survival via Cox proportional hazards regression. Additionally, several studies reported correlations between exposure and adverse events, though conclusions varied substantially across studies.</p> Conclusion <p>Multiple studies demonstrated that lower osimertinib steady-state trough concentration correlated with longer progression-free survival in Non-Small-Cell Lung Cancer, challenging the conventional assumption that higher drug exposure directly translates to superior efficacy. No consistent overall survival association exists. The relationships of adverse events remain unclear due to inconsistent study outcomes. These findings highlight the need for personalized dosing strategies through further research.</p>

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A systematic review and meta-analysis of exposure-response analysis of osimertinib in patients with non-small-cell lung cancer

  • 期刊论文

  • 发表日期：

    2026年4月1日

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  • Weifeng Shao,
  • Jingyi Yang,
  • Liying Wu,
  • Yue Zhou,
  • Zhiheng Yu,
  • Yinchu Cheng,
  • Qiushi Cai,
  • Wei Liu

摘要

Purpose

Osimertinib displays substantial inter-individual variability in both pharmacokinetics and pharmacodynamics. This study aimed to explore the exposure-response relationship of osimertinib, thereby to provide a basis for personalized therapeutic strategies.

Methods

We systematically searched PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, Wanfang Database, and China Biology Medicine Literature Database separately through October 2024, with no study type restrictions. The Newcastle-Ottawa Scale was used for quality assessment, and data were extracted and recorded using Excel software. The meta-analysis was conducted using Stata software.

Results

A total of nine observational studies were included. Among them, five studies identified a correlation between steady-state trough concentration and progression-free survival, with three specifically demonstrating that the low steady-state trough concentration group had longer progression-free survival. One study observed a negative correlation between clearance and overall survival via Cox proportional hazards regression. Additionally, several studies reported correlations between exposure and adverse events, though conclusions varied substantially across studies.

Conclusion

Multiple studies demonstrated that lower osimertinib steady-state trough concentration correlated with longer progression-free survival in Non-Small-Cell Lung Cancer, challenging the conventional assumption that higher drug exposure directly translates to superior efficacy. No consistent overall survival association exists. The relationships of adverse events remain unclear due to inconsistent study outcomes. These findings highlight the need for personalized dosing strategies through further research.