Multicentre prospective phase II trial of gefitinib for advanced non-small cell lung cancer with epidermal growth factor receptor mutations: results of the West Japan Thoracic Oncology Group trial (WJTOG0403).
Multicentre prospective phase II trial of gefitinib for advanced non-small cell lung cancer with epidermal growth factor receptor mutations: results of the West Japan Thoracic Oncology Group trial (WJTOG0403).
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DOI：
10.1038/sj.bjc.6604249
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发表时间：
2008-03-11
影响因子：
8.8
通讯作者：
Fukuoka, M.
中科院分区：
文献类型：
--
作者：
Tamura, K.;Okamoto, I.;Kashii, T.;Negoro, S.;Hirashima, T.;Kudoh, S.;Ichinose, Y.;Ebi, N.;Shibata, K.;Nishimura, T.;Katakami, N.;Sawa, T.;Shimizu, E.;Fukuoka, J.;Satoh, T.;Fukuoka, M.
关键词：
本研究的目的是评估吉非替尼的疗效以及在选择的晚期非小细胞肺癌（NSCLC）患者中筛查表皮生长因子受体（EGFR）突变的可行性。IIIB/IV期NSCLC、化疗初治患者或最多2种既往化疗方案后复发的患者符合资格。由中心实验室使用肿瘤标本的DNA进行直接测序，以检测EGFR突变。携带EGFR突变的患者接受吉非替尼治疗。主要研究目的是缓解;次要目的是毒性、总生存期（OS）、无进展生存期（PFS）、1年生存期（1 Y-S）和疾病控制率（DCR）。在2005年3月至2006年1月期间，从15个机构招募了118名患者，并对EGFR突变进行了筛查，在32名患者中检测到EGFR突变-其中28名患者入选本研究。总缓解率为75%，DCR为96%，中位PFS为11.5个月。尚未达到中位OS，1 Y-S为79%。因此，吉非替尼化疗在携带EGFR突变的晚期NSCLC患者中非常有效。本试验记录了使用中心分型实验室进行多中心II期研究的可行性，证明了根据EGFR突变状态选择吉非替尼治疗的患者的获益。
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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