First-line osimertinib in patients with epidermal growth factor receptor–mutant non–small-cell lung cancer and with a coexisting low allelic fraction of Thr790Met

奥西默替尼 医学 内科学 肺癌 肿瘤科 四分位间距 临床终点 表皮生长因子受体 临床研究阶段 无进展生存期 置信区间 胃肠病学 外科 癌症 临床试验 化疗 埃罗替尼
作者
Margarita Majem,Ivanna Sullivan,Santiago Viteri,Guillermo López-Vivanco,Manuel Cobo,José Miguel Sánchez,Jorge García,J. Garde,Miguel Sampayo,Griselda Martrat,Andrea Malfettone,Niki Karachaliou,Miguel Ángel Molina‐Vila,Rafael Rosell
出处
期刊:European Journal of Cancer [Elsevier BV]
卷期号:159: 174-181 被引量:7
标识
DOI:10.1016/j.ejca.2021.09.039
摘要

The AZENT (NCT02841579) study aimed to assess the efficacy and safety of first-line osimertinib in patients with epidermal growth factor receptor(EGFR)mutation-positive advanced non-small-cell lung cancer (NSCLC) and with a coexisting low allelic fraction of Thr790Met.In this multicentre, single-arm, open-label, phase IIa study, patients with locally advanced or metastatic NSCLC harbouring centrally confirmedEGFR Thr790Met mutation received 80 mg osimertinib daily. The primary end-point was objective response rate (ORR). The secondary end-points included disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Efficacy was assessed as per Response Evaluation Criteria in Solid Tumours, version 1.1. Blood samples collected at baseline, end of week 2 and disease progression were analysed using next-generation sequencing. As osimertinib was approved as a first-line therapy during the trial, this led to early termination of phase II; thus, analysis is considered exploratory.Twenty-two patients were enrolled and received osimertinib. All 22 patients were included in the efficacy and safety analysis. At the data cutoff, 10 (50%) patients remained on treatment. The median duration of follow-up was 24.4 months (interquartile range 12.9 to 26.0). The ORR was 77.3% (17/22 [95% confidence interval {CI} 54.6 to 89.3]). The DCR was 86.4% (19/22, [95% CI 65.1 to 97.1]). The median PFS was 23.1 months (95% CI 14.1 to NE). The median OS was 28·4 months (95% CI 25.6 to NE).Despite early study termination, osimertinib first-line therapy yields an overall PFS of 23.1 months in EGFR-mutant patients harbouring a coexisting low allelic fraction of EGFR Thr790Met mutation.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
噜噜噜噜噜完成签到,获得积分10
刚刚
赵慧霞关注了科研通微信公众号
刚刚
炎魔之王拉格纳罗斯完成签到,获得积分10
1秒前
内向苡完成签到,获得积分10
2秒前
以筱发布了新的文献求助10
4秒前
bhkwxdxy完成签到,获得积分10
5秒前
悦耳虔纹完成签到 ,获得积分10
5秒前
xx完成签到,获得积分10
5秒前
大气灵枫完成签到,获得积分10
5秒前
妮妮完成签到,获得积分10
6秒前
8秒前
Struggle完成签到 ,获得积分10
9秒前
9秒前
秦兴虎完成签到,获得积分10
10秒前
Drew11完成签到,获得积分10
10秒前
风趣青槐完成签到,获得积分10
12秒前
科隆龙完成签到,获得积分10
13秒前
13秒前
饱满一手完成签到 ,获得积分10
13秒前
99完成签到,获得积分10
15秒前
枕星发布了新的文献求助10
15秒前
drlq2022完成签到,获得积分10
16秒前
王山完成签到,获得积分10
17秒前
自觉寒梦完成签到,获得积分10
18秒前
ding应助缥缈一刀采纳,获得10
18秒前
pakiorder发布了新的文献求助10
18秒前
专心搞学术完成签到,获得积分10
18秒前
bkagyin应助zzcherished采纳,获得10
20秒前
你怎么这么可爱啊完成签到,获得积分10
20秒前
21秒前
研友_Lmg1gZ完成签到,获得积分10
21秒前
Crazyer完成签到,获得积分10
21秒前
Shuey完成签到,获得积分10
22秒前
XXXXH完成签到,获得积分10
22秒前
Z可完成签到 ,获得积分10
23秒前
momo123完成签到 ,获得积分10
23秒前
高兴的书竹完成签到 ,获得积分10
24秒前
mp5完成签到,获得积分10
25秒前
薯条一克完成签到 ,获得积分10
25秒前
zzcherished完成签到,获得积分10
26秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Handbook of Industrial Diamonds.Vol2 1100
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038303
求助须知:如何正确求助?哪些是违规求助? 3576013
关于积分的说明 11374210
捐赠科研通 3305780
什么是DOI,文献DOI怎么找? 1819322
邀请新用户注册赠送积分活动 892672
科研通“疑难数据库(出版商)”最低求助积分说明 815029