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Clinical Cancer Research Vol. 11, 1167-1173, February 2005
© 2005 American Association for Cancer Research

Imaging, Diagnosis, Prognosis

The Relationship between Epidermal Growth Factor Receptor Mutations and Clinicopathologic Features in Non–Small Cell Lung Cancers

Masaki Tokumo1, Shinichi Toyooka1, Katsuyuki Kiura2, Hisayuki Shigematsu5, Kunitoshi Tomii1, Motoi Aoe1, Kouichi Ichimura3, Toshihide Tsuda4, Masaaki Yano1, Kazunori Tsukuda1, Masahiro Tabata2, Hiroshi Ueoka2, Mitsune Tanimoto2, Hiroshi Date1, Adi F. Gazdar5,6 and Nobuyoshi Shimizu1

Departments of 1 Cancer and Thoracic Surgery, 2 Hematology, Oncology and Respiratory Medicine, 3 Pathology, and 4 Hygiene and Preventive Medicine, Graduate School of Medicine and Dentistry, Okayama University, Okayama, Japan and 5 Hamon Center for Therapeutic Oncology Research and 6 Department of Pathology, University of Texas Southwestern Medical Center, Dallas, Texas

Requests for reprints: Shinichi Toyooka, Department of Cancer and Thoracic Surgery, Okayama University Graduate School of Medicine and Dentistry, 2-5-1 Shikata-cho, Okayama 700-8558, Japan. Phone: 81-86-235-7265; Fax: 81-86-235-7269. E-mail: shin_toyooka{at}yahoo.co.jp.

Purpose: Recent studies reported that clinical responsiveness to gefitinib was associated with somatic mutation of epidermal growth factor receptor (EGFR) gene in non–small cell lung cancers (NSCLC). Here, we investigated the relationship between EGFR mutation and clinicopathologic features.

Experimental Design: EGFR mutational status of 120 NSCLCs was determined mainly in EGFR exons 18 to 21 by direct sequence and correlated with clinicopathologic parameters.

Results: EGFR mutations were present in 38 cases (32%) and the majority of mutations were in-frame deletions of exon 19 (19 cases) and a missense mutation in exon 21 (18cases). EGFR mutations were frequently associated with adenocarcinoma (P < 0.0001), never smoker (P < 0.0001), and female gender (P = 0.0001). Of interest, increasing smoke exposure was inversely related to the rate of EGFR mutation (P < 0.0001). Multivariate analysis showed that smoking and histology were independent variables. Furthermore, gender difference was observed for the mutational location (P = 0.01) dominance of exon 19 for males and exon 21 for females. Twenty-one cases were treated with gefitinib and found that EGFR mutation was significantly related to gefitinib responsiveness (P = 0.002). In addition, median survival times of patients with and without EGFR mutations treated with gefitinib were 25.1 and 14.0 months, respectively. Patients with EGFR mutations had approximately 2-fold survival advantage; however, the difference was not significant.

Conclusions: We show that EGFR mutations were significantly related to histology and smoke exposure and were a strong predictive factor for gefitinib responsiveness in NSCLC.

Key Words: lung cancer • EGFR • gefitinib • smoking




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