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- Title
Multi-institutional study of osimertinib dose-optimization in non-small cell lung cancer patients with EGFR activating mutation aged 70 years or older ('MONEY' trial).
- Authors
Tsukita, Yoko; Taguri, Masataka; Goto, Yasushi; Hosomi, Yukio; Mizutani, Tomonori; Watanabe, Kageaki; Yoh, Kiyotaka; Takahashi, Satoshi; Kubota, Kaoru; Kunitoh, Hideo
- 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.
- Publication
Japanese Journal of Clinical Oncology, 2024, Vol 54, Issue 6, p730
- ISSN
0368-2811
- Publication type
Article
- DOI
10.1093/jjco/hyae032