TY - JOUR
T1 - Multicentre prospective phase II trial of gefitinib for advanced non-small cell lung cancer with epidermal growth factor receptor mutations
T2 - Results of the West Japan Thoracic Oncology Group trial (WJTOG0403)
AU - Tamura, K.
AU - Okamoto, I.
AU - Kashii, T.
AU - Negoro, S.
AU - Hirashima, T.
AU - Kudoh, S.
AU - Ichinose, Y.
AU - Ebi, N.
AU - Shibata, K.
AU - Nishimura, T.
AU - Katakami, N.
AU - Sawa, T.
AU - Shimizu, E.
AU - Fukuoka, J.
AU - Satoh, T.
AU - Fukuoka, M.
N1 - Funding Information:
1Outpatients Treatment Center, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan; 2Department of Medical Oncology, Kinki University School of Medicine, 377-2, Ohno-higashi, Sayama, Osaka 589-8511, Japan; 3Department of Clinical Oncology, Osaka City General Hospital, 2-13-22, Miyakojima-hondori, Miyakojima, Osaka 534-0021, Japan; 4Department of Thoracic Oncology, Hyogo Cancer Center, 13-70, Akashi, Kitaouji, Hyogo 673-8558, Japan; 5Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, 3-7-1, Habikino, Habikino, Osaka 583-8588, Japan; 6Department of Respiratory Medicine, Osaka City University Medical School, 1-5-7, Asahi, Abeno, Osaka 545-8586, Japan; 7Department of Thoracic Oncology, National Kyusyu Cancer Center, 3-1-1, Nodame, Minami, Fukuoka 811-1347, Japan; 8Department of Respiratory Medicine, Iizuka Hospital, 3-83, Yoshio, Iizuka, Fukuoka 820-8505, Japan; 9Department of Medicine, Koseiren Takaoka Hospital, 5-10, Eiraku, Takaoka, Toyama 933-8555, Japan; 10Division of Respiratory Medicine, Kobe City General Hospital, 4-6, Minatojima-nakamachi, Chuo-ku, Kobe, Hyogo 650-0046, Japan; 11Department of Integrated Oncology, Institute of Biomedical Research and Innovation, 2-2, Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan; 12Department of Respiratory Medicine, Gifu Municipal Hospital, 7-1, Kashima, Gifu 500-8323, Japan; 13Division of Medical Oncology and Respiratory Medicine, Faculty of Medicine, Tottori University, 36-1, Nishi-machi, Yonago, Tottori 683-8504, Japan; 14Laboratory of Pathology, Toyama University Hospital, Toyama, 2630, Sugitani, Toyama 930-0194, Japan; 15Department of Medical Oncology, Kinki University School of Medicine, Sakai Hospital, 2-7-1, Harayamadai, Minami-ku, Sakai, Osaka 590-0132, Japan
PY - 2008/3/11
Y1 - 2008/3/11
N2 - The purpose of this study was to evaluate the efficacy of gefitinib and the feasibility of screening for epidermal growth factor receptor (EGFR) mutations among select patients with advanced non-small cell lung cancer (NSCLC). Stage IIIB/IV NSCLC, chemotherapy-naive patients or patients with recurrences after up to two prior chemotherapy regimens were eligible. Direct sequencing using DNA from tumour specimens was performed by a central laboratory to detect EGFR mutations. Patients harbouring EGFR mutations received gefitinib. The primary study objective was response; the secondary objectives were toxicity, overall survival (OS), progression-free survival (PFS), 1-year survival (1Y-S) and the disease control rate (DCR). Between March 2005 and January 2006, 118 patients were recruited from 15 institutions and were screened for EGFR mutations, which were detected in 32 patients - 28 of whom were enrolled in the present study. The overall response rate was 75%, the DCR was 96% and the median PFS was 11.5 months. The median OS has not yet been reached, and the 1Y-S was 79%. Thus, gefitinib chemotherapy in patients with advanced NSCLC harbouring EGFR mutations was highly effective. This trial documents the feasibility of performing a multicentre phase II study using a central typing laboratory, demonstrating the benefit to patients of selecting gefitinib treatment based on their EGFR mutation status.
AB - The purpose of this study was to evaluate the efficacy of gefitinib and the feasibility of screening for epidermal growth factor receptor (EGFR) mutations among select patients with advanced non-small cell lung cancer (NSCLC). Stage IIIB/IV NSCLC, chemotherapy-naive patients or patients with recurrences after up to two prior chemotherapy regimens were eligible. Direct sequencing using DNA from tumour specimens was performed by a central laboratory to detect EGFR mutations. Patients harbouring EGFR mutations received gefitinib. The primary study objective was response; the secondary objectives were toxicity, overall survival (OS), progression-free survival (PFS), 1-year survival (1Y-S) and the disease control rate (DCR). Between March 2005 and January 2006, 118 patients were recruited from 15 institutions and were screened for EGFR mutations, which were detected in 32 patients - 28 of whom were enrolled in the present study. The overall response rate was 75%, the DCR was 96% and the median PFS was 11.5 months. The median OS has not yet been reached, and the 1Y-S was 79%. Thus, gefitinib chemotherapy in patients with advanced NSCLC harbouring EGFR mutations was highly effective. This trial documents the feasibility of performing a multicentre phase II study using a central typing laboratory, demonstrating the benefit to patients of selecting gefitinib treatment based on their EGFR mutation status.
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U2 - 10.1038/sj.bjc.6604249
DO - 10.1038/sj.bjc.6604249
M3 - Article
C2 - 18283321
AN - SCOPUS:40349111048
VL - 98
SP - 907
EP - 914
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 5
ER -