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Originally published as JCO Early Release 10.1200/JCO.2005.00.992 on February 28 2005

Journal of Clinical Oncology, Vol 23, No 11 (April 10), 2005: pp. 2513-2520
© 2005 American Society of Clinical Oncology.
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Mutations of the Epidermal Growth Factor Receptor Gene Predict Prolonged Survival After Gefitinib Treatment in Patients With Non–Small-Cell Lung Cancer With Postoperative Recurrence

Tetsuya Mitsudomi, Takayuki Kosaka, Hideki Endoh, Yoshitsugu Horio, Toyoaki Hida, Shoichi Mori, Shunzo Hatooka, Masayuki Shinoda, Takashi Takahashi, Yasushi Yatabe

From the Departments of Thoracic Surgery, Thoracic Oncology, and Pathology and Molecular Diagnostics, Aichi Cancer Center Hospital; and Division of Molecular Oncology, Aichi Cancer Center Research Institute, Aichi Cancer Center, Nagoya, Japan

Address reprint requests to Tetsuya Mitsudomi, MD, Department of Thoracic Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan; e-mail: mitsudom{at}aichi-cc.jp.

PURPOSE: To evaluate the relationship between mutations of the epidermal growth factor receptor (EGFR) gene and the effectiveness of gefitinib treatment in patients with recurrent lung cancer after pulmonary resection.

PATIENTS AND METHODS: We sequenced exons 18-21 of the EGFR gene using total RNA extracted from 59 patients with lung cancer who were treated with gefitinib for recurrent lung cancer. Gefitinib effectiveness was evaluated by both imaging studies and change in serum carcinoembryonic antigen (CEA) levels.

RESULTS: EGFR mutations were found in 33 patients (56%). Of these mutations, 17 were deletions around codons 746-750 and 15 were point mutations (12 at codon 858, three at other codons), and one was an insertion. EGFR mutations were significantly more prevalent in females, adenocarcinoma, and never-smokers. Gefitinib treatment resulted in tumor shrinkage and/or CEA decrease to less than half of the baseline level in 26 patients, tumor growth and/or CEA elevation in 24 patients, and gefitinib effect was not assessable in nine patients. Female, never-smoking patients with adenocarcinoma tended to respond better to gefitinib treatment. Gefitinib was effective in 24 of 29 patients with EGFR mutations, compared with two of 21 patients without mutations (P < .0001). Of note, del746-750 might be superior to L858R mutations for prediction of gefitinib response. Patients with EGFR mutations survived for a longer period than those without the mutations after initiation of gefitinib treatment (P = .0053).

CONCLUSION: EGFR mutations were a good predictor of clinical benefit of gefitinib in this setting.

Supported in part by Grant-in-Aid (16591424) from the Ministry of Education, Culture, Sports, Science and Technology of Japan.

Terms in blue are defined in the glossary, found at the end of this issue and online at www.jco.org.

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




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