文章基本信息

标题：The Dissociation of Gefitinib Trough Concentration and Clinical Outcome in NSCLC Patients with EGFR Sensitive Mutations
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作者：Shuang Xin ; Yuanyuan Zhao ; Xueding Wang 等
期刊名称：Scientific Reports
电子版ISSN：2045-2322
出版年度：2015
卷号：5
DOI：10.1038/srep12675
出版社：Springer Nature
摘要：Gefitinib is an essential drug for NSCLC patients harboring EGFR sensitive mutations. The approved dose 250mg/day is based on limited clinical trials, this research aims to explore the relationship between drug exposure and gefitinib response. C_trough of 87 NSCLC patients harboring EGFR sensitive mutations were determined by LC-MS/MS. The median of C_trough was 173.9 ng/ml ( P ₂₅– P ₇₅, 130.5–231.2 ng/ml), and cutoff value 200 ng/ml was determined by X-Tile. The PFS between C_trough trough ≥ 200 ng/ml groups were not significantly different (17.3 VS 14.8 months; p = 0.258). C_trough was not significantly associated with rash, diarrhea and hepatotoxicity. Non-smokers enjoyed longer PFS than smokers (18.7 VS 9.3 months; p = 0.025). The results showed that, for NSCLC patients with EGFR sensitive mutations, the PFS in lower trough concentration group were not inferior to that in higher trough concentration group and dose reduction is a rational suggestion for adjustment of dose regimen for aforementioned patients. More clinical trials are warranted to explore the precision dose schedule of gefitinib.