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Originally published as JCO Early Release 10.1200/JCO.2005.01.0793 on July 5 2005

Journal of Clinical Oncology, Vol 23, No 28 (October 1), 2005: pp. 6829-6837
© 2005 American Society of Clinical Oncology.
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Epidermal Growth Factor Receptor Gene Mutations and Increased Copy Numbers Predict Gefitinib Sensitivity in Patients With Recurrent Non–Small-Cell Lung Cancer

Toshimi Takano, Yuichiro Ohe, Hiromi Sakamoto, Koji Tsuta, Yoshihiro Matsuno, Ukihide Tateishi, Seiichiro Yamamoto, Hiroshi Nokihara, Noboru Yamamoto, Ikuo Sekine, Hideo Kunitoh, Tatsuhiro Shibata, Tokuki Sakiyama, Teruhiko Yoshida, Tomohide Tamura

From the Divisions of Internal Medicine and Diagnostic Radiology and Clinical Laboratory Division, National Cancer Center Hospital; Genetics and Pathology Divisions, National Cancer Center Research Institute; and Statistics and Cancer Control Division, Research Center for Cancer Prevention and Screening, National Cancer Center, Tokyo, Japan

Address reprint requests to Toshimi Takano, MD, Division of Internal Medicine, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan; e-mail: totakano{at}ncc.go.jp

PURPOSE: To evaluate epidermal growth factor receptor (EGFR) mutations and copy number as predictors of clinical outcome in patients with non–small-cell lung cancer (NSCLC) receiving gefitinib.

PATIENTS AND METHODS: Sixty-six patients with NSCLC who experienced relapse after surgery and received gefitinib were included. Direct sequencing of exons 18 to 24 of EGFR and exons 18 to 24 of ERBB2 was performed using DNA extracted from surgical specimens. Pyrosequencing and quantitative real-time polymerase chain reaction were performed to analyze the allelic pattern and copy number of EGFR.

RESULTS: Thirty-nine patients (59%) had EGFR mutations; 20 patients had deletional mutations in exon 19, 17 patients had missense mutations (L858R) in exon 21, and two patients had missense mutations (G719S or G719C) in exon 18. No mutations were identified in ERBB2. Response rate (82% [32 of 39 patients] v 11% [three of 27 patients]; P < .0001), time to progression (TTP; median, 12.6 v 1.7 months; P < .0001), and overall survival (median, 20.4 v 6.9 months; P = .0001) were significantly better in patients with EGFR mutations than in patients with wild-type EGFR. Increased EGFR copy numbers (≥ 3/cell) were observed in 29 patients (44%) and were significantly associated with a higher response rate (72% [21 of 29 patients] v 38% [14 of 37 patients]; P = .005) and a longer TTP (median, 9.4 v 2.6 months; P = .038). High EGFR copy numbers (≥ 6/cell) were caused by selective amplification of mutant alleles.

CONCLUSION: EGFR mutations and increased copy numbers were significantly associated with better clinical outcome in gefitinib-treated NSCLC patients.

Supported by a program for the promotion of Fundamental Studies in Health Sciences of the Pharmaceuticals and Medical Devices Agency and by Health and Labour Science Research Grants from the Ministry of Health, Labour and Welfare.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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