title: Evaluation of epidermal growth factor receptor mutation status in serum DNA as a predictor of response to gefitinib (IRESSA).
abstract: The aim of this study was to evaluate the usefulness of EGFR mutation status in serum DNA as a means of predicting a benefit from gefitinib (IRESSA) therapy in Japanese patients with non-small cell lung cancer (NSCLC). We obtained pairs of tumour and serum samples from 42 patients treated with gefitinib. EGFR mutation status was determined by a direct sequencing method and by Scorpion Amplification Refractory Mutation System (ARMS) technology. EGFR mutations were detected in the tumour samples of eight patients and in the serum samples of seven patients. EGFR mutation status in the tumours and serum samples was consistent in 39 (92.9%) of the 42 pairs. EGFR mutations were strong correlations between both EGFR mutation status in the tumour samples and serum samples and objective response to gefitinib (P<0.001). Median progression-free survival time was significantly longer in the patients with EGFR mutations than in the patients without EGFR mutations (194 vs 55 days, P=0.016, in tumour samples; 174 vs 58 days, P=0.044, in serum samples). The results suggest that it is feasible to use serum DNA to detect EGFR mutation, and that it's potential as a predictor of response to, and survival on gefitinib is worthy of further evaluation.
authors.affiliation: Department of Respiratory Medicine, Kanazawa University Hospital, Takara-machi 13-1, Kanazawa, Ishikawa, Japan. kimura@med3.m.kanazawa-u.ac.jp
authors.forename: H
authors.initials: H
authors.lastname: Kimura
authors.forename: M
authors.initials: M
authors.lastname: Suminoe
authors.forename: K
authors.initials: K
authors.lastname: Kasahara
authors.forename: T
authors.initials: T
authors.lastname: Sone
authors.forename: T
authors.initials: T
authors.lastname: Araya
authors.forename: S
authors.initials: S
authors.lastname: Tamori
authors.forename: F
authors.initials: F
authors.lastname: Koizumi
authors.forename: K
authors.initials: K
authors.lastname: Nishio
authors.forename: K
authors.initials: K
authors.lastname: Miyamoto
authors.forename: M
authors.initials: M
authors.lastname: Fujimura
authors.forename: S
authors.initials: S
authors.lastname: Nakao
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000494:pharmacology* / Q000627:therapeutic use; D044466:Asian People / Q000235:genetics; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics* / Q000401:mortality; D004273:DNA, Neoplasm / Q000032:analysis / Q000302:isolation & purification; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000235:genetics*; D005260:Female; D000077156:Gefitinib; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011237:Predictive Value of Tests; D047428:Protein Kinase Inhibitors / Q000494:pharmacology; D011799:Quinazolines / Q000494:pharmacology* / Q000627:therapeutic use; D012680:Sensitivity and Specificity
chemical_list: D000970:Antineoplastic Agents; D004273:DNA, Neoplasm; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D066246:ErbB Receptors; D000077156:Gefitinib