IR@PKUHSC  > 北京大学临床肿瘤学院
学科主题临床医学
Final overall survival results from a randomised, phase III study of erlotinib versus chemotherapy as first-line treatment of EGFR mutation-positive advanced non-small-cell lung cancer (OPTIMAL, CTONG-0802)
Zhou, C.1; Wu, Y. L.2; Chen, G.3; Feng, J.4; Liu, X. -Q.5; Wang, C.6; Zhang, S.7; Wang, J.8; Zhou, S.1; Ren, S.1; Lu, S.9; Zhang, L.10; Hu, C.11; Hu, C.12; Luo, Y.13; Chen, L.14; Ye, M.15; Huang, J.16; Zhi, X.17; Zhang, Y.18; Xiu, Q.19; Ma, J.20; Zhang, L.21; You, C.22
关键词Chemotherapy Egfr Mutations Erlotinib Non-small-cell Lung Cancer Overall Survival
刊名ANNALS OF ONCOLOGY
2015-09-01
DOI10.1093/annonc/mdv276
26期:9页:1877-1883
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Oncology
研究领域[WOS]Oncology
关键词[WOS]OPEN-LABEL ; CARBOPLATIN-PACLITAXEL ; TRIAL ; ADENOCARCINOMA ; GEFITINIB ; AFATINIB ; MULTICENTER ; GEMCITABINE ; EURTAC ; NSCLC
英文摘要

The OPTIMAL study was the first study to compare efficacy and tolerability of the epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) erlotinib, versus standard chemotherapy in first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). Findings from final overall survival (OS) analysis and assessment of post-study treatment impact are presented.

Of 165 randomised patients, 82 received erlotinib and 72 gemcitabine plus carboplatin. Final OS analyses were conducted when 70% of deaths had occurred in the intent-to-treat population. Subgroup OS was analysed by Cox proportional hazards model and included randomisation stratification factors and post-study treatments.

Median OS was similar between the erlotinib (22.8 months) and chemotherapy (27.2 months) arms with no significant between-group differences in the overall population [hazard ratio (HR), 1.19; 95% confidence interval (CI) 0.83-1.71; P = 0.2663], the exon 19 deletion subpopulation (HR, 1.52; 95% CI 0.91-2.52; P = 0.1037) or the exon 21 L858 mutation subpopulation (HR, 0.92; 95% CI 0.55-1.54; P = 0.7392). More patients in the erlotinib arm versus the chemotherapy arm did not receive any post-study treatment (36.6% versus 22.2%). Patients who received sequential combination of EGFR-TKI and chemotherapy had significantly improved OS compared with those who received EGFR-TKI or chemotherapy only (29.7 versus 20.7 or 11.2 months, respectively; P < 0.0001). OS was significantly shorter in patients who did not receive post-study treatments compared with those who received subsequent treatments in both arms.

The significant OS benefit observed in patients treated with EGFR-TKI emphasises its contribution to improving survival of EGFR mutant NSCLC patients, suggesting that erlotinib should be considered standard first-line treatment of EGFR mutant patients and EGFR-TKI treatment following first-line therapy also brings significant benefits to those patients.

语种英语
WOS记录号WOS:000361392700011
项目编号06DZ19502
资助机构F. Hoffmann-La Roche (China) ; Science and Technology Commission of Shanghai Municipality
引用统计
被引频次:121[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/400002259/50104
专题北京大学临床肿瘤学院
作者单位1.Peking Univ, Sch Oncol, Beijing Canc Hosp, Beijing 100871, Peoples R China
2.Tongji Univ, Sch Med, Shanghai Pulm Hosp, Dept Oncol, Shanghai 200433, Peoples R China
3.Guangdong Acad Med Sci, Guangdong Gen Hosp, Guangdong Lung Canc Inst, Guangzhou, Guangdong, Peoples R China
4.Harbin Med Univ, Canc Hosp, Dept Tumour Med, Harbin, Peoples R China
5.Jiangsu Prov Canc Hosp, Dept Med Oncol, Nanjing, Jiangsu, Peoples R China
6.Acad Mil Med Sci, Hosp 307, Ctr Canc, Dept Pulm Oncol, Beijing, Peoples R China
7.Tianjin Canc Hosp, Dept Med Oncol, Tianjin, Peoples R China
8.Capital Med Univ, Beijing Chest Hosp, Beijing, Peoples R China
9.Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai 200030, Peoples R China
10.Sun Yat Sen Univ, Ctr Canc, Guangzhou 510275, Guangdong, Peoples R China
11.Cent S Univ, Xiangya Hosp, Changsha, Hunan, Peoples R China
12.Cent S Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China
13.Hunan Prov Canc Hosp, Changsha, Hunan, Peoples R China
14.Shantou Univ, Coll Med, Canc Hosp, Shantou, Peoples R China
15.Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Shanghai 200030, Peoples R China
16.Suzhou Univ, Affiliated Hosp 1, Suzhou 215006, Peoples R China
17.Capital Med Univ, Xuanwu Hosp, Dept Thorac Surg, Beijing, Peoples R China
18.Zhejiang Canc Hosp, Hangzhou, Zhejiang, Peoples R China
19.Second Mil Med Univ, Changzheng 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.Southern Med Univ, Nanfang Hosp, Guangzhou, Guangdong, Peoples R China
推荐引用方式
GB/T 7714
Zhou, C.,Wu, Y. L.,Chen, G.,et al. Final overall survival results from a randomised, phase III study of erlotinib versus chemotherapy as first-line treatment of EGFR mutation-positive advanced non-small-cell lung cancer (OPTIMAL, CTONG-0802)[J]. ANNALS OF ONCOLOGY,2015,26(9):1877-1883.
APA Zhou, C..,Wu, Y. L..,Chen, G..,Feng, J..,Liu, X. -Q..,...&You, C..(2015).Final overall survival results from a randomised, phase III study of erlotinib versus chemotherapy as first-line treatment of EGFR mutation-positive advanced non-small-cell lung cancer (OPTIMAL, CTONG-0802).ANNALS OF ONCOLOGY,26(9),1877-1883.
MLA Zhou, C.,et al."Final overall survival results from a randomised, phase III study of erlotinib versus chemotherapy as first-line treatment of EGFR mutation-positive advanced non-small-cell lung cancer (OPTIMAL, CTONG-0802)".ANNALS OF ONCOLOGY 26.9(2015):1877-1883.
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