LBA68 FLAURA2: Safety and CNS outcomes of first-line (1L) osimertinib (osi) ± chemotherapy (CTx) in EGFRm advanced NSCLC

医学 培美曲塞 内科学 肿瘤科 中止 化疗 顺铂
作者
David Planchard,Pasi A. Jänne,Ying Cheng,Chee Khoon Lee,К. К. Лактионов,Tong‐Yuan Yang,Yan Yu,Terufumi Kato,Liyan Jiang,Busyamas Chewaskulyong,Sarayut Lucien Geater,J-M. Maurel,Celeste Rojas,Libor Havel,Frances A. Shepherd,Kentaro Tanaka,Dana Ghiorghiu,Edgar Monterroso,Xiangning Huang,J.C.-H. Yang
出处
期刊:Annals of Oncology [Elsevier BV]
卷期号:34: S1311-S1312 被引量:2
标识
DOI:10.1016/j.annonc.2023.10.069
摘要

In FLAURA2 (NCT04035486), osi, a 3rd gen CNS-active EGFR-TKI, combined with platinum-pemetrexed (osi-CTx) showed a statistically significant improvement vs osi-monotherapy (osi-mono) in PFS per investigator (HR [95% CI]: 0.62 [0.49–0.79], p<0.001) with a manageable and tolerable safety profile. Addition of CTx did not affect osi exposure. 76% of pts completed 4 CTx cycles; median duration of pemetrexed exposure was 8.3 mos. 40% of FLAURA2 pts had baseline CNS metastases (mets); we report exploratory analyses of CNS efficacy by CNS blinded independent central review (BICR; conducted by neuroradiologist). Updated safety data will be reported. Eligible pts (≥18 y [Japan: ≥20] with EGFRm advanced NSCLC, no prior tx for advanced NSCLC; asymptomatic CNS mets not requiring steroids or stable >2 wks after definitive tx/steroids were allowed) were randomised 1:1 to 1L osi-CTx or osi-mono until progression/discontinuation. Brain imaging (MRI preferred) was performed in all pts at baseline + progression, and at scheduled assessments until progression for pts with baseline CNS mets. CNS endpoints (modified RECIST1.1) included CNS PFS, CNS response and CNS DoR by CNS BICR. Safety was assessed by CTCAE v5. Data cutoff: 3 Apr 2023. Of 557 pts randomised, 118/279 (osi-CTx) and 104/278 (osi-mono) were included in the CNS BICR full analysis set (cFAS; pts with ≥1 measurable and/or non-measurable lesion); 40/118 (osi-CTx) and 38/104 (osi-mono) were included in the CNS evaluable for response set (cEFR; pts with ≥1 measurable lesion). Demographics were balanced across tx arms. CNS efficacy is shown (Table). Safety profile was similar in the cFAS and overall population. The safety and tolerability profile during the course of tx will be described. In FLAURA2, pts with CNS mets in the osi-CTx arm had a clinically meaningful reduction in the risk of CNS progression, with high CNS ORR (and high CR) and durable responses, with a manageable and tolerable safety profile.Table: LBA68cFAScEFROsi-CTx(n=118)Osi-mono(n=104)Osi-CTx(n=40)Osi-mono(n=38)CNS ORR, n (%)86 (73)72 (69)35 (88)33 (87)- CR, n (%)70 (59)45 (43)19 (48)6 (16)Median CNS DoR, mos (95% CI)NR (23.8–NC)26.2 (19.4–NC)NR (21.6–NC)20.9 (12.6–NC)BICR CNS PFS- HR (95% CI)*0.58 (0.33–1.01)0.40 (0.19–0.84)- Median, mos (95% CI)30.2 (28.4–NC)27.6 (22.1–NC)NR (23.0–NC)17.3 (13.9–NC)*Analysed using stratified (cFAS; by race, WHO PS and EGFRm test method) or unstratified (cEFR) log-rank testCR, complete response; DoR, duration of response; NC, not calculable; NR, not reached; ORR, objective response rate; PFS, progression-free survival Open table in a new tab
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
why完成签到,获得积分10
刚刚
刚刚
刚刚
CodeCraft应助明眸采纳,获得10
刚刚
naitangkeke发布了新的文献求助10
1秒前
难过的谷芹应助李治稳采纳,获得10
2秒前
2秒前
问心发布了新的文献求助10
2秒前
予安发布了新的文献求助10
2秒前
研友_VZG7GZ应助lili采纳,获得10
3秒前
3秒前
小小的飞机完成签到,获得积分10
3秒前
脑洞疼应助wendinfgmei采纳,获得10
4秒前
long发布了新的文献求助10
6秒前
xiemeili发布了新的文献求助10
7秒前
7秒前
在水一方应助完美的流沙采纳,获得10
7秒前
江阳宏发布了新的文献求助10
7秒前
8秒前
FashionBoy应助W~舞采纳,获得10
8秒前
8秒前
生动的电脑完成签到,获得积分10
9秒前
苗条储发布了新的文献求助10
9秒前
9秒前
painx完成签到,获得积分10
10秒前
ff完成签到,获得积分10
10秒前
小蘑菇应助naitangkeke采纳,获得10
10秒前
11秒前
666完成签到,获得积分10
11秒前
tyx完成签到,获得积分20
11秒前
12秒前
12秒前
12秒前
nini完成签到 ,获得积分10
13秒前
结实雪卉完成签到,获得积分10
13秒前
椛鈊发布了新的文献求助10
13秒前
华仔应助甜美的一笑采纳,获得10
13秒前
Venus发布了新的文献求助10
14秒前
15秒前
wendinfgmei发布了新的文献求助10
16秒前
高分求助中
Picture Books with Same-sex Parented Families: Unintentional Censorship 700
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
Effective Learning and Mental Wellbeing 300
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 3974712
求助须知:如何正确求助?哪些是违规求助? 3519159
关于积分的说明 11197254
捐赠科研通 3255257
什么是DOI,文献DOI怎么找? 1797724
邀请新用户注册赠送积分活动 877130
科研通“疑难数据库(出版商)”最低求助积分说明 806132