IR@PKUHSC  > 北京大学临床肿瘤学院  > 流行病学研究室
学科主题临床医学
Second-line pemetrexed versus docetaxel in Chinese patients with locally advanced or metastatic non-small cell lung cancer: A randomized, open-label study
Sun, Y.1; Wu, Y. -L.2,3; Zhou, C. -C.4; Zhang, L.5; Zhang, L.6; Liu, X. -Y.7; Yu, S. -Y.8; Jiang, G. -L.9; Li, K.10; Qin, S. -K.11; Ma, S. -L.12; Han, L.13; Quinlivan, M.14; Orlando, M.15; Zhang, X. -Q.16
关键词Carcinoma Clinical trial Docetaxel Non-small-cell lung Pemetrexed
刊名LUNG CANCER
2013-02-01
DOI10.1016/j.lungcan.2012.10.015
79期:2页:143-150
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]PHASE-III TRIAL ; PREVIOUSLY TREATED PATIENTS ; THYMIDYLATE SYNTHASE ; MULTITARGETED ANTIFOLATE ; EGFR MUTATIONS ; CHEMOTHERAPY ; EFFICACY ; GEFITINIB ; HISTOLOGY ; LY231514
英文摘要

` Introduction: This randomized, open-label study compared pemetrexed versus docetaxel as second-line therapy for Chinese patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary endpoint tested non-inferiority of overall survival (OS) on the combined data from these patients and those in the global registration trial. Data from patients in the current study only (Chinese patients) were the basis for the study′s secondary objectives.

Methods: Patients with stage IIIB/IV disease were randomized (1:1) to receive pemetrexed (500 mg/m(2); 107 randomized; 106 treated) or docetaxel (75 mg/m(2); 104 randomized; 102 treated) on Day 1 of each 21-day cycle. Treatment continued until progressive disease, unacceptable toxicity or patient/investigator decision. All efficacy and safety data were analyzed at the pre-specified study completion; supplementary OS analyses were performed later, after additional events had been recorded.

Results: The primary endpoint of OS noninferiority of pemetrexed to docetaxel was not met, the lower CL was <50% and P > 0.025 (efficacy retained = 97.9% [95% CLs: 47.1, 141.9]; P = 0.0276), in the combined population (pemetrexed: n = 390, docetaxel: n = 392). Supplementary values were 101.3% (95% CLs: 57.9, 148.8), P = 0.0186. For the secondary objectives, assessed in the population from the current study (pemetrexed: n = 107, docetaxel: n = 104), median OS was 11.7 and 12.2 months for the pemetrexed and docetaxel arms, respectively (HR [95% CLs]: 1.14 [0.78, 1.68], P = 0.492). Supplementary values were 11.4 and 11.5 months, respectively (HR [95% CLs]: 1.02 [0.74, 1.40], P = 0.926). Median PFS values were 2.8 and 3.1 months (HR [95% CLs]: 1.05 [0.75, 1.46], P = 0.770) and ORR values were 9.6% and 4.1% (odds ratio [95% CLs]: 2.50 [0.76, 8.25], P = 0.133) for pemetrexed and docetaxel, respectively. Pemetrexed-treated patients had significantly fewer drug-related grade 3-4 adverse events (pemetrexed: 20.8%, docetaxel: 40.2%; P= 0.003). Few drug-related serious adverse events were reported (pemetrexed: 5 patients, docetaxel: 8 patients).

Conclusion: The comparable efficacy and superior tolerability of pemetrexed compared with docetaxel in this study supports the use of single-agent, second-line pemetrexed for advanced non-squamous NSCLC in Chinese patients. ClinicalTrials.gov: NCT00391274. (c) 2012 Published by Elsevier Ireland Ltd.

语种英语
WOS记录号WOS:000314381100008
资助机构Eli Lilly and Company, Indianapolis, IN ; Eli Lilly and Company
引用统计
被引频次:17[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/400002259/64416
专题北京大学临床肿瘤学院_流行病学研究室
作者单位1.81st Hosp PLA, Dept Oncol, Nanjing, Jiangsu, Peoples R China
2.Eli Lilly Asia, Oncol, Shanghai, Peoples R China
3.Chinese Acad Med Sci, Canc Inst & Hosp, Beijing 100021, Peoples R China
4.Guangdong Gen Hosp, Guangdong Lung Canc Inst, Guangzhou, Guangdong, Peoples R China
5.Guangdong Acad Med Sci, Guangzhou, Guangdong, Peoples R China
6.Tongji Univ, Affiliated Canc Inst, Shanghai Pulm Hosp, Dept Oncol,Sch Med, Shanghai 200092, Peoples R China
7.Sun Yat Sen Univ Med Sci, Tumor Hosp, Dept Med Oncol, Guangzhou, Guangdong, Peoples R China
8.Peking Univ, Dept Canc Epidemiol, Sch Oncol, Beijing Canc Hosp & Inst, Beijing 100871, Peoples R China
9.Peking Univ, Dept Med Oncol Lung Canc, Sch Oncol, Beijing Canc Hosp & Inst, Beijing 100871, Peoples R China
10.Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Oncol, Wuhan 430074, Peoples R China
11.Fudan Univ, Dept Radiat Oncol, Shanghai Canc Ctr, Shanghai 200433, Peoples R China
12.Tianjin Med Univ, Canc Hosp, Dept Thorac Oncol, Tianjin, Peoples R China
13.Zhejiang Canc Hosp, Dept Chemotherapy Ctr, Hangzhou, Zhejiang, Peoples R China
14.Eli Lilly & Co, Dev Ctr Excellence Asia Pacific, Shanghai, Peoples R China
15.Eli Lilly & Co, Dev Ctr Excellence Asia Pacific, Macquarie Pk, NSW, Australia
16.Eli Lilly Interamer Inc, Oncol Emerging Markets, Buenos Aires, DF, Argentina
推荐引用方式
GB/T 7714
Sun, Y.,Wu, Y. -L.,Zhou, C. -C.,et al. Second-line pemetrexed versus docetaxel in Chinese patients with locally advanced or metastatic non-small cell lung cancer: A randomized, open-label study[J]. LUNG CANCER,2013,79(2):143-150.
APA Sun, Y..,Wu, Y. -L..,Zhou, C. -C..,Zhang, L..,Zhang, L..,...&Zhang, X. -Q..(2013).Second-line pemetrexed versus docetaxel in Chinese patients with locally advanced or metastatic non-small cell lung cancer: A randomized, open-label study.LUNG CANCER,79(2),143-150.
MLA Sun, Y.,et al."Second-line pemetrexed versus docetaxel in Chinese patients with locally advanced or metastatic non-small cell lung cancer: A randomized, open-label study".LUNG CANCER 79.2(2013):143-150.
条目包含的文件
条目无相关文件。
个性服务
推荐该条目
保存到收藏夹
查看访问统计
导出为Endnote文件
谷歌学术
谷歌学术中相似的文章
[Sun, Y.]的文章
[Wu, Y. -L.]的文章
[Zhou, C. -C.]的文章
百度学术
百度学术中相似的文章
[Sun, Y.]的文章
[Wu, Y. -L.]的文章
[Zhou, C. -C.]的文章
必应学术
必应学术中相似的文章
[Sun, Y.]的文章
[Wu, Y. -L.]的文章
[Zhou, C. -C.]的文章
相关权益政策
暂无数据
收藏/分享
所有评论 (0)
暂无评论
 

除非特别说明,本系统中所有内容都受版权保护,并保留所有权利。