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- Title
The Dissociation of Gefitinib Trough Concentration and Clinical Outcome in NSCLC Patients with EGFR Sensitive Mutations.
- Authors
Xin, Shuang; Zhao, Yuanyuan; Wang, Xueding; Huang, Yan; Zhang, Jing; Guo, Ying; Li, Jiali; Li, Hongliang; Ma, Yuxiang; Chen, Lingyan; Hu, Zhihuang; Huang, Min; Zhang, Li
- Abstract
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. Ctrough of 87 NSCLC patients harboring EGFR sensitive mutations were determined by LC-MS/MS. The median of Ctrough was 173.9 ng/ml (P25-P75, 130.5-231.2 ng/ml), and cutoff value 200 ng/ml was determined by X-Tile. The PFS between Ctrough < 200 ng/ml and Ctrough ≥ 200 ng/ml groups were not significantly different (17.3 VS 14.8 months; p = 0.258). Ctrough 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.
- Subjects
CANCER treatment; NON-small-cell lung carcinoma; GEFITINIB; CLINICAL trials; IDIOSYNCRATIC drug reactions; EPIDERMAL growth factor receptors; GENETIC mutation
- Publication
Scientific Reports, 2015, p12675
- ISSN
2045-2322
- Publication type
Article
- DOI
10.1038/srep12675