FOLFIRI plus ramucirumab versus paclitaxel plus ramucirumab as second-line therapy for patients with advanced or metastatic gastroesophageal adenocarcinoma with or without prior docetaxel – results from the phase II RAMIRIS Study of the German Gastric Cancer Study Group at AIO

催眠药 福尔菲里 医学 多西紫杉醇 内科学 临床终点 转移性乳腺癌 危险系数 人口 临床研究阶段 紫杉醇 肿瘤科 化疗 胃肠病学 外科 癌症 置信区间 随机对照试验 乳腺癌 伊立替康 结直肠癌 环境卫生
作者
Sylvie Lorenzen,Peter Thuss‐Patience,Claudia Pauligk,Eray Gökkurt,Thomas Jens Ettrich,Florian Lordick,Michael Stahl,Peter Reichardt,Martin Sökler,Daniel Pink,Stefan Probst,Axel Hinke,Thorsten Oliver Goetze,S. Al-Batran
出处
期刊:European Journal of Cancer [Elsevier]
卷期号:165: 48-57 被引量:24
标识
DOI:10.1016/j.ejca.2022.01.015
摘要

Ramucirumab and paclitaxel is the standard second-line therapy in patients with metastatic gastroesophageal adenocarcinoma. We report the efficacy and safety analyses of FOLFIRI and ramucirumab versus paclitaxel and ramucirumab after the failure of a platinum- and fluoropyrimidine-containing chemotherapy.This multicenter, investigator initiated, phase II trial randomised patients with gastroesophageal adenocarcinoma to either FOLFIRI plus ramucirumab (RAM) (arm A) or paclitaxel plus RAM (arm B). The primary end-point was 6-month overall survival (OS) rate, with a proportion of ≥65% in arm A considered a positive signal for further investigation.111 patients (65% of patients had prior docetaxel) were enrolled and 110 patients qualified for ITT population (arm A, 72; arm B, 38). The study did not meet the primary end-point for the comparison with historical control, as 6-month OS rate in the FOLFIRI plus RAM arm was 54% (95% CI 44-67). In between arm comparison, OS was similar (hazard ratio, HR 0.97 [95% CI 0.62-1.52]), while objective response rates (ORRs) and PFS were numerically better in arm A versus arm B (HR for PFS 0.73; ORR, 22% versus 11%). These differences were largely attributed to favourable efficacy results for arm A in docetaxel-pretreated patients (HR, 0.49; ORR, 25% versus 8%). In the safety population (n = 106), grade 3-5 adverse events were similar between arms (arm A, 75%; arm B, 68%).The RAMIRIS trial demonstrated feasibility of FOLFIRI plus RAM. While the study was formally negative, it provided a signal to further investigate this combination for the group of patients with previous docetaxel therapy.clinicaltrials.gov identifier: NCT03081143.
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
大幅提高文件上传限制,最高150M (2024-4-1)

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
脑洞疼应助文龙采纳,获得10
刚刚
竹纤维完成签到 ,获得积分10
1秒前
mehplamnha完成签到,获得积分10
1秒前
重要的耳机完成签到,获得积分10
2秒前
xixi完成签到,获得积分10
2秒前
传奇3应助犹豫梦旋采纳,获得10
2秒前
gy发布了新的文献求助10
3秒前
铲铲完成签到,获得积分10
4秒前
柔之完成签到,获得积分10
4秒前
zj完成签到,获得积分10
5秒前
大模型应助星河采纳,获得10
6秒前
华仔应助菜大炮采纳,获得10
8秒前
sun完成签到,获得积分10
8秒前
gy完成签到,获得积分20
9秒前
asdfghjk完成签到,获得积分10
9秒前
Orange应助甜美百褶裙采纳,获得10
9秒前
所所应助飘逸凝丝采纳,获得10
9秒前
温柔惜筠完成签到,获得积分10
13秒前
albertchan完成签到,获得积分10
15秒前
raoxray完成签到 ,获得积分10
16秒前
17秒前
清爽的元灵完成签到 ,获得积分10
18秒前
菜大炮完成签到,获得积分10
19秒前
斯文败类应助希勤采纳,获得10
20秒前
姜sir发布了新的文献求助10
21秒前
22秒前
24秒前
24秒前
gzw应助慕白采纳,获得10
24秒前
甜美百褶裙完成签到,获得积分20
25秒前
26秒前
26秒前
小白完成签到,获得积分10
26秒前
lzd完成签到,获得积分10
26秒前
27秒前
27秒前
慕容真发布了新的文献求助10
28秒前
欣常在完成签到 ,获得积分10
28秒前
mengli完成签到 ,获得积分10
29秒前
科研通AI2S应助听寒采纳,获得10
31秒前
高分求助中
Sustainability in Tides Chemistry 2800
The Young builders of New china : the visit of the delegation of the WFDY to the Chinese People's Republic 1000
Rechtsphilosophie 1000
Bayesian Models of Cognition:Reverse Engineering the Mind 888
Le dégorgement réflexe des Acridiens 800
Defense against predation 800
Very-high-order BVD Schemes Using β-variable THINC Method 568
热门求助领域 (近24小时)
化学 医学 生物 材料科学 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 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3134917
求助须知:如何正确求助?哪些是违规求助? 2785800
关于积分的说明 7774138
捐赠科研通 2441635
什么是DOI,文献DOI怎么找? 1298038
科研通“疑难数据库(出版商)”最低求助积分说明 625075
版权声明 600825