A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations.

Content Provider	Europe PMC
Author	Asahina, H Yamazaki, K Kinoshita, I Sukoh, N Harada, M Yokouchi, H Ishida, T Ogura, S Kojima, T Okamoto, Y Fujita, Y Dosaka–akita, H Isobe, H Nishimura, M
Copyright Year	2006
Abstract	Retrospective analysis has shown that activating mutations in exons 18–21 of the epidermal growth factor receptor (EGFR) gene are a predictor of response to gefitinib. We conducted a phase II trial to evaluate the efficacy and safety of gefitinib as first-line therapy for advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Patients with stage IIIB or IV chemotherapy-naïve NSCLC with EGFR mutation were treated with 250 mg gefitinib daily. For mutational analysis, DNA was extracted from paraffin-embedded tissues and EGFR mutations were analysed by direct sequence of PCR products. Twenty (24%) of the 82 patients analysed had EGFR mutations (deletions in or near E746-A750, n=16; L858R, n=4). Sixteen patients were enrolled and treated with gefitinib. Twelve patients had objective response and response rate was 75% (95% CI, 48–93%). After a median follow-up of 12.7 months (range, 3.1–16.8 months), 10 patients demonstrated disease progression, with median progression-free survival of 8.9 months (95% CI, 6.7–11.1 months). The median overall survival time has not yet been reached. Most of the toxicities were mild. This study showed that gefitinib is very active and well tolerated as first-line therapy for advanced NSCLC with EGFR mutations.
ISSN	00070920
Journal	British Journal of Cancer
Volume Number	95
PubMed Central reference number	PMC2360715
Issue Number	8
PubMed reference number	17047648
e-ISSN	15321827
DOI	10.1038/sj.bjc.6603393
Language	English
Publisher	Nature Publishing Group
Publisher Date	2006-10-01
Access Restriction	Open
Rights License	This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material.If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/. Copyright © 2006 Cancer Research UK
Subject Keyword	gefitinib non-small cell lung cancer (NSCLC) epidermal growth factor receptor (EGFR) mutation first-line therapy
Content Type	Text
Resource Type	Article
Subject	Cancer Research Oncology