IR@PKUHSC  > 北京大学临床肿瘤学院
学科主题临床医学
Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study
Zhou, Caicun1; Wu, Yi-Long2; Chen, Gongyan3; Feng, Jifeng4; Liu, Xiao-Qing5; Wang, Changli6; Zhang, Shucai7; Wang, Jie9; Zhou, Songwen1; Ren, Shengxiang1; Lu, Shun11; Zhang, Li12,21; Hu, Chengping13; Hu, Chunhong14; Luo, Yi15; Chen, Lei16; Ye, Ming10; Huang, Jianan17; Zhi, Xiuyi8; Zhang, Yiping18; Xiu, Qingyu19; Ma, Jun20; Zhang, Li; You, Changxuan22
刊名LANCET ONCOLOGY
2011-08-01
DOI10.1016/S1470-2045(11)70184-X
12期:8页:735-742
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Oncology
资助者F Hoffmann-La Roche (China) ; Science and Technology Commission of Shanghai Municipality ; F Hoffmann-La Roche (China) ; Science and Technology Commission of Shanghai Municipality
研究领域[WOS]Oncology
关键词[WOS]FACTOR RECEPTOR MUTATIONS ; GEFITINIB ; MANAGEMENT ; TRIAL
英文摘要

Background Activating mutations in EGFR are important markers of response to tyrosine kinase inhibitor (TKI) therapy in non-small-cell lung cancer (NSCLC). The OPTIMAL study compared efficacy and tolerability of the TKI erlotinib versus standard chemotherapy in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC.

Methods We undertook an open-label, randomised, phase 3 trial at 22 centres in China. Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) received either oral erlotinib (150 mg/day) until disease progression or unacceptable toxic effects, or up to four cycles of gemcitabine plus carboplatin. Patients were randomly assigned (1:1) with a minimisation procedure and were stratified according to EGFR mutation type, histological subtype (adenocarcinoma vs non-adenocarcinoma), and smoking status. The primary outcome was progression-free survival, analysed in patients with confirmed disease who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov, number NCT00874419, and has completed enrolment; patients are still in follow-up.

Findings 83 patients were randomly assigned to receive erlotinib and 82 to receive gemcitabine plus carboplatin; 82 in the erlotinib group and 72 in the chemotherapy group were included in analysis of the primary endpoint. Median progression-free survival was significantly longer in erlotinib-treated patients than in those on chemotherapy (13.1 [95% CI 10.58-16.53] vs 4.6 [4.21-5.42] months; hazard ratio 0.16, 95% CI 0.10-0.26; p<0.0001). Chemotherapy was associated with more grade 3 or 4 toxic effects than was erlotinib (including neutropenia in 30 [42%] of 72 patients and thrombocytopenia in 29 [40%] patients on chemotherapy vs no patients with either event on erlotinib); the most common grade 3 or 4 toxic effects with erlotinib were increased alanine aminotransferase concentrations (three [4%] of 83 patients) and skin rash (two [2%] patients). Chemotherapy was also associated with increased treatment-related serious adverse events (ten [14%] of 72 patients [decreased platelet count, n=8; decreased neutrophil count, n=1; hepatic dysfunction, n=1] vs two [2%] of 83 patients [both hepatic dysfunction]).

Interpretation Compared with standard chemotherapy, erlotinib conferred a significant progression-free survival benefit in patients with advanced EGFR mutation-positive NSCLC and was associated with more favourable tolerability. These findings suggest that erlotinib is important for first-line treatment of patients with advanced EGFR mutation-positive NSCLC.

语种英语
所属项目编号06DZ19502
资助者F Hoffmann-La Roche (China) ; Science and Technology Commission of Shanghai Municipality ; F Hoffmann-La Roche (China) ; Science and Technology Commission of Shanghai Municipality
WOS记录号WOS:000293272100024
引用统计
被引频次:1721[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/67838
专题北京大学临床肿瘤学院
作者单位1.Harbin Med Univ, Canc Hosp, Harbin, Peoples R China
2.Hunan Prov Canc Hosp, Changsha, Hunan, Peoples R China
3.Shantou Univ, Coll Med, Canc Hosp, Shantou, Peoples R China
4.Suzhou Univ, Affiliated Hosp 1, Suzhou 215006, Peoples R China
5.Jiangsu Prov Canc Hosp, Nanjing, Peoples R China
6.Tianjin Canc Hosp, Tianjin, Peoples R China
7.Capital Med Univ, Xuanwu Hosp, Beijing, Peoples R China
8.Cent S Univ, Xiangya Hosp, Changsha, Hunan, Peoples R China
9.Tongji Univ, Sch Med, Shanghai Pulm Hosp, Dept Oncol, Shanghai 200092, Peoples R China
10.Guangdong Acad Med Sci, Guangdong Gen Hosp, Guangdong Lung Canc Inst, Guangzhou, Guangdong, Peoples R China
11.Acad Mil Med Sci, Hosp 307, Ctr Canc, Dept Pulm Oncol, Beijing, Peoples R China
12.Capital Med Univ, Beijing Chest Hosp, Beijing, Peoples R China
13.Peking Univ, Sch Oncol, Beijing Canc Hosp, Beijing 100871, Peoples R China
14.Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Shanghai 200030, Peoples R China
15.Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai 200030, Peoples R China
16.Sun Yat Sen Univ, Ctr Canc, Guangzhou 510275, Guangdong, Peoples R China
17.Cent S Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China
18.Zhejiang Canc Hosp, Hangzhou, Zhejiang, Peoples R China
19.Second Mil Med Univ, Changzhen Hosp, Shanghai, Peoples R China
20.Harbin Inst Hematol & Oncol, Harbin, Peoples R China
21.Beijing Union Med Coll Hosp, Beijing, Peoples R China
22.So Med Univ, Nanfang Hosp, Guangzhou, Guangdong, Peoples R China
推荐引用方式
GB/T 7714
Zhou, Caicun,Wu, Yi-Long,Chen, Gongyan,et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study[J]. LANCET ONCOLOGY,2011,12(8):735-742.
APA Zhou, Caicun.,Wu, Yi-Long.,Chen, Gongyan.,Feng, Jifeng.,Liu, Xiao-Qing.,...&You, Changxuan.(2011).Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study.LANCET ONCOLOGY,12(8),735-742.
MLA Zhou, Caicun,et al."Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study".LANCET ONCOLOGY 12.8(2011):735-742.
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