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学科主题: 临床医学
题名:
Final Overall Survival Results from a Phase III, Randomized, Placebo-Controlled, Parallel-Group Study of Gefitinib Versus Placebo as Maintenance Therapy in Patients with Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (INFORM; C-TONG 0804)
作者: Zhao, Hongyun1,2,3; Fan, Yun4; Ma, Shenglin5; Song, Xiangqun6; Han, Baohui7; Cheng, Ying8; Huang, Cheng9; Yang, Shujun10; Liu, Xiaoqing11; Liu, Yunpeng12; Lu, Shun13; Wang, Jie14; Zhang, Shucai15; Zhou, Caicun16; Wang, Mengzhao17; Zhang, Li1,2,3; INFORM Investigators
关键词: Gefitinib ; Maintenance ; NSCLC ; INFORM ; OS
刊名: JOURNAL OF THORACIC ONCOLOGY
发表日期: 2015-04-01
DOI: 10.1097/JTO.0000000000000445
卷: 10, 期:4, 页:655-664
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology ; Respiratory System
研究领域[WOS]: Oncology ; Respiratory System
关键词[WOS]: GROWTH-FACTOR RECEPTOR ; PLATINUM-BASED CHEMOTHERAPY ; 1ST-LINE CHEMOTHERAPY ; CLINICAL-TRIALS ; ADVANCED NSCLC ; DOUBLE-BLIND ; MUTATIONS ; GEMCITABINE ; CISPLATIN ; ERLOTINIB
英文摘要:

Background: The results of the Iressa in NSCLC for maintenance study (NCT00770588; C-TONG 0804), which compared gefitinib and placebo as maintenance therapy in patients with advanced non-small-cell lung cancer without disease progression after first-line chemotherapy, were published previously. The objective of this report is to provide a mature analysis of overall survival (OS) for Iressa in NSCLC for maintenance study in intention to treat (ITT) population and in subgroups according to epidermal growth factor receptor (EGFR) mutation status.

Patients and Methods: A total of 296 patients were randomly assigned. EGFR mutations were detected using an amplification mutation refractory system. Seventy-nine patients were assessable for EGFR mutations. OS was analyzed by a Cox proportional hazards model adjusted for the same covariates in ITT population and subgroups according to EGFR mutation status.

Results: OS was similar for gefitinib and placebo arm with no significant difference between treatments in ITT population (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.68-1.14; p = 0.335) and in subgroups with wild type EGFR (HR, 1.27; 95% CI, 0.7-2.3; p = 0.431) or unknown EGFR mutations (HR, 0.92; 95% CI, 0.68, 1.25; p = 0.603). In the EGFR mutation-positive subgroup, the gefitinib arm showed a higher OS than the placebo arm (HR, 0.39; 95% CI, 0.15, 0.97; p = 0.036).

Conclusion: EGFR mutation was the strongest predictive biomarker for OS benefit of gefitinib as maintenance treatment. The analyses of OS showed that patients achieve a clear and significant survival benefit if they receive EGFR tyrosine kinase inhibitors as maintenance treatment in EGFR mutation-positive patients.

语种: 英语
所属项目编号: 2012AA02A502 ; 2013ZX09401003-002 ; 81372502 ; 320.6750.131
项目资助者: AstraZeneca ; Lilly ; Aventis ; National High Technology Research and Development Program of China ; Innovative drug R&amp ; D center based on real-time high-throughput cell-based screening platform and large capacity compound library ; National Natural Science Funds of China ; Wu Jieping Medical Foundation Project
WOS记录号: WOS:000351675400018
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/61342
Appears in Collections:北京大学临床肿瘤学院_胸部肿瘤内科_期刊论文

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作者单位: 1.State Key Lab Oncol South China, Dept Med Oncol, Guangzhou, Guangdong, Peoples R China
2.Collaborat Innovat Ctr Canc Med, Dept Med Oncol, Guangzhou, Guangdong, Peoples R China
3.Sun Yat Sen Univ Canc Ctr, Dept Med Oncol, Guangzhou, Guangdong, Peoples R China
4.Zhejiang Canc Hosp, Dept Med Oncol, Hangzhou, Zhejiang, Peoples R China
5.Hangzhou First Pepoles Hosp, Dept Radiat Therapy, Hangzhou, Zhejiang, Peoples R China
6.Guangxi Zhuang Autonomous Reg Tumour Hosp, Dept Med Oncol, Nanning, Peoples R China
7.Shanghai Chest Hosp, Dept Pulm Med, Shanghai, Peoples R China
8.Jilin Prov Tumour Hosp, Dept Med Oncol, Changchun, Peoples R China
9.Fujian Prov Tumor Hosp, Dept Resp Med, Fuzhou, Peoples R China
10.Henan Prov Tumour Hosp, Dept Chemotherapy, Zhengzhou, Peoples R China
11.People Liberat Army, Dept Oncol, Hosp 307, Beijing, Peoples R China
12.China Med Univ, Hosp 1, Dept Med Oncol, Shenyang 110001, Peoples R China
13.Shanghai Jiao Tong Univ, Sch Med, Shanghai Chest Hosp, Dept Shanghai Lung Canc Ctr, Beijing, Peoples R China
14.Beijing Canc Hosp, Dept Thorac Med Oncol, Beijing, Peoples R China
15.Beijing Chest Hosp, Dept Med Oncol, Beijing, Peoples R China
16.Tongji Univ, Dept Oncol, Shanghai Pulm Hosp, Sch Med, Shanghai 200092, Peoples R China
17.Peking Union Med Coll, Dept Resp Dis, Beijing 100021, Peoples R China

Recommended Citation:
Zhao, Hongyun,Fan, Yun,Ma, Shenglin,et al. Final Overall Survival Results from a Phase III, Randomized, Placebo-Controlled, Parallel-Group Study of Gefitinib Versus Placebo as Maintenance Therapy in Patients with Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (INFORM; C-TONG 0804)[J]. JOURNAL OF THORACIC ONCOLOGY,2015,10(4):655-664.
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