版权说明 帮助中心 进入管理中心
首页 > 成果 > 详情

Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial.

ESI高被引SCI-EMedline
WOS被引频次:564
认领
导出
Link by DOI
反馈
分享
QQ微信 微博
成果类型:
期刊论文
作者:
Wu, Yi-Long;Zhou, Caicun;Hu, Cheng-Ping;Feng, Jifeng;Lu, Shun;Huang, Yunchao;Li, Wei;Hou, Mei;Shi, Jian Hua;Lee, Kye Young;Xu, Chong-Rui;Massey, Dan;Kim, Miyoung;Shi, Yang;Geater, Sarayut L.
通讯作者:
Wu, YL
作者机构:
[Huang, Yunchao] Yunnan Tumor Hospital (The Third Affiliated Hospital of Kunming Medical University), Kunming, Yunnan Province, China
[Feng, Jifeng] Department of Internal Medicine, Jiangsu Provincial Tumor Hospital, Nanjing, Jiangsu, China
[Massey, Dan] Boehringer Ingelheim, Bracknell, UK
[Lu, Shun] Shanghai Lung Tumor Clinical Medical Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China
[Shi, Yang] Boehringer Ingelheim International Trading, Shanghai, China
通讯机构:
[Wu, Yi-Long] Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China. Electronic address:
语种:
英文
期刊:
The Lancet. Oncology
ISSN:
1470-2045
年:
2014
卷:
15
期:
2
页码:
213-222
文献类别:
WOS:Article
所属学科:
ESI学科类别:临床医学;WOS学科类别:Oncology
入藏号:
WOS:000330228700034;PMID:24439929
基金类别:
Boehringer Ingelheim
机构署名:
本校为其他机构
院系归属:
基础医学院
临床肿瘤学院
摘要:
BACKGROUND: Afatinib-an oral irreversible ErbB family blocker-improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). We compared afatinib with gemcitabine and cisplatin-a chemotherapy regimen widely used in Asia-for first-line treatment of Asian patients with EGFR mutation-positive advanced NSCLC. METHODS: This open-label, randomised phase 3 trial was done at 36 centres in China, Thailand, and South Korea. After central testing for EGFR mutations, treatment-naive patients (stage IIIB or IV cancer [American Joint Committee on Cancer version 6], performance status 0-1) were randomly assigned (2:1) to receive either oral afatinib (40 mg per day) or intravenous gemcitabine 1000 mg/m(2) on day 1 and day 8 plus cisplatin 75 mg/m(2) on day 1 of a 3-week schedule for up to six cycles. Randomisation was done centrally with a random number-generating system and an interactive internet and voice-response system. Randomisation was stratified by EGFR mutation (Leu858Arg, exon 19 deletions, or other; block size three). Clinicians and patients were not masked to treatment assignment, but the independent central imaging review group were. Treatment continued until disease progression, intolerable toxic effects, or withdrawal of consent. The primary endpoint was progression-free survival assessed by independent central review (intention-to-treat population). This study is registered with ClinicalTrials.gov, NCT01121393. FINDINGS: 910 patients were screened and 364 were randomly assigned (242 to afatinib, 122 to gemcitabine and cisplatin). Median progression-free survival was significantly longer in the afatinib group (11.0 months, 95% CI 9.7-13.7) than in the gemcitabine and cisplatin group (5.6 months, 5.1-6.7; hazard ratio 0.28, 95% CI 0.20-0.39; p<0.0001). The most common treatment-related grade 3 or 4 adverse events in the afatinib group were rash or acne (35 [14.6%] of 239 patients), diarrhoea (13 [5.4%]), and stomatitis or mucositis (13 [5.4%]), compared with neutropenia (30 [26.5%] of 113 patients), vomiting (22 [19.5%]), and leucopenia (17 [15.0%]) in the gemcitabine and cisplatin group. Treatment-related serious adverse events occurred in 15 (6.3%) patients in the afatinib group and nine (8.0%) patients in the gemcitabine and cisplatin group. INTERPRETATION: First-line afatinib significantly improves progression-free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutation-positive advanced lung NSCLC. Afatinib should be considered as a first-line treatment option for this patient population. FUNDING: Boehringer Ingelheim.
参考文献:
AARONSON NK, 1993, J NATL CANCER I, V85, P365, DOI 10.1093/jnci/85.5.365
BERGMAN B, 1994, EUR J CANCER, V30A, P635, DOI 10.1016/0959-8049(94)90535-5
Osoba D, 1998, J CLIN ONCOL, V16, P139
Li D, 2008, ONCOGENE, V27, P4702, DOI 10.1038/onc.2008.109
Peters S, 2012, ANN ONCOL, V23, P56, DOI 10.1093/annonc/mds226

反馈

验证码:
看不清楚,换一个
确定
取消

成果认领

标题:
用户 作者 通讯作者
请选择
请选择
确定
取消

提示

该栏目需要登录且有访问权限才可以访问

如果您有访问权限,请直接 登录访问

如果您没有访问权限,请联系管理员申请开通

管理员联系邮箱:yun@hnwdkj.com