Prospective phase II study of gefitinib in non-small cell lung cancer with epidermal growth factor receptor gene mutations

• Published in: Lung cancer (Amsterdam, Netherlands) Vol. 64; no. 3; pp. 314 - 318
• Main Authors: Sugio, Kenji, Uramoto, Hidetaka, Onitsuka, Takamitsu, Mizukami, Makiko, Ichiki, Yoshinobu, Sugaya, Masakazu, Yasuda, Manabu, Takenoyama, Mitsuhiro, Oyama, Tsunehiro, Hanagiri, Takeshi, Yasumoto, Kosei
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ireland Ltd 01.06.2009; Elsevier
• Subjects: Acquired resistance; Adenocarcinoma; Aged; Aged, 80 and over; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - diagnosis; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - genetics; Carcinoma, Non-Small-Cell Lung - pathology; Disease-Free Survival; EGFR; Exons; Female; Hematology, Oncology and Palliative Medicine; Humans; Lung Neoplasms - diagnosis; Lung Neoplasms - drug therapy; Lung Neoplasms - genetics; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; Mutation; Neoplasm Staging; NSCLC; Pneumology; Prospective Studies; Prospective study; Pulmonary/Respiratory; Quinazolines - administration & dosage; Receptor, Epidermal Growth Factor - genetics; T790M; Treatment Outcome; Tumors; Tumors of the respiratory system and mediastinum; Adenocarcinoma; T790M; Acquired resistance; NSCLC; Prospective study; EGFR; Lung disease; Acquired; Respiratory disease; Malignant tumor; non-small cell lung carcinoma; Epidermal growth factor receptor; Prospective; Resistance; Cancerology; Gene; Phase II trial; Bronchus disease; Mutation; Gefitinib; Cancer; Non small cell carcinoma; Pneumology
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/j.lungcan.2008.09.010

Abstract Background This study prospectively assessed the efficacy of gefitinib and the survival benefit for non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations. Method Patients with either recurrent disease after undergoing surgery or advanced NSCLC disease (IIIB or IV) which demonstrated EGFR mutations were eligible for this study. EGFR mutations in exons 19–21 were examined. The patients with EGFR mutations were enrolled in this study after obtaining their informed consent a second time, and they were thereafter treated with gefitinib. Results EGFR mutations were detected in 20 of 48 patients with NSCLC, and 19 patients were enrolled onto this study and treated with gefitinib. Seven patients had an exon 19 deletion, 10 had L858R, 1 had both, and 1 had an exon 19 deletion and G796A. The overall response rate was 63.2%, and the disease control rate was 89.5%. In patients with an exon 19 del and L858R, the response rates were 71.4% and 60.0%, respectively. The median progression-free survival time was 7.1 months, and the median survival time was 20.0 months. No life-threatening toxicity was observed. Four of five acquired resistant tumors showed an acquired T790M mutation. Conclusions EGFR mutations in exons 19 or 21 are considered to be a good predictor of the efficacy of gefitinib.