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Updated: Jun 30, 2025
Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids
Published on: November 22, 2021
Multi-institutional study of osimertinib dose-optimization in non-small cell lung cancer patients with EGFR
Yoko Tsukita1, Masataka Taguri2, Yasushi Goto3
1Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Abstract:
Osimertinib is the standard of care for patients with epidermal growth factor receptor-activating mutation-positive non-small cell lung cancer. Dose-toxicity has been previously reported, but no dose-response data within the range of 20-240 mg daily (mg/d). Thus, the current 80 mg/d dosing might be too high for elderly Japanese patients with an average body weight of only 50 kg, resulting in excessive toxicity and cost. We therefore initiated a study to investigate whether osimertinib at 40 mg/d is non-inferior to 80 mg/d in patients with advanced or recurrent epidermal growth factor receptor-activating mutation-positive non-small cell lung cancer aged ≥70 years, using a regression discontinuity design. Osimertinib is administered at 40 mg/d for body weight ≤50 kg, and 80 mg/d for body weight >50 kg. The primary endpoint is progression-free survival. Sample size is 550 patients, based on a non-inferiority margin of the progression-free survival hazard ratio 1.333, 0.10 one-sided type I error and 80% power.
Insights
This study compares 40 mg/d versus 80 mg/d of osimertinib in elderly Japanese patients with non-small cell lung cancer. Lower osimertinib doses may reduce toxicity and cost without compromising efficacy.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trial Design
Background:
- Osimertinib is a standard treatment for EGFR-mutated non-small cell lung cancer (NSCLC).
- Current dosing (80 mg/d) may cause excessive toxicity and cost in elderly Japanese patients (average weight 50 kg).
- Limited dose-response data exists within the 20-240 mg/d range.
Purpose of the Study:
- To investigate if 40 mg/d osimertinib is non-inferior to 80 mg/d in elderly Japanese patients with advanced or recurrent EGFR-mutated NSCLC.
- To evaluate dose-response and optimize osimertinib treatment for specific patient populations.
Main Methods:
- A regression discontinuity design study.
- Inclusion criteria: age ≥70 years, advanced/recurrent EGFR-mutated NSCLC.
- Dosing strategy: 40 mg/d for body weight ≤50 kg, 80 mg/d for body weight >50 kg.
- Primary endpoint: progression-free survival.
- Sample size: 550 patients.
Main Results:
- Study is ongoing; results not yet available.
Conclusions:
- Study aims to determine optimal osimertinib dosing for elderly Japanese NSCLC patients.
- Findings could lead to reduced toxicity and healthcare costs.
- Potential to refine treatment guidelines for specific patient demographics.
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