亲爱的研友该休息了!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!身体可是革命的本钱,早点休息,好梦!

Atezolizumab monotherapy versus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis from a randomised, controlled, phase 3 study

阿替唑单抗 医学 转移性尿路上皮癌 安慰剂 内科学 肿瘤科 化疗 癌症 膀胱癌 彭布罗利珠单抗 免疫疗法 尿路上皮癌 病理 替代医学
作者
Aristotelis Bamias,Ian D. Davis,Matthew D. Galsky,José Ángel Arranz,Eiji Kikuchi,Enrique Grande,Xavier García del Muro,Se Hoon Park,Ugo De Giorgi,B. Yа. Alekseev,Marina Mencinger,Kouji Izumi,Fabio A.B. Schutz,Javier Puente,Jian‐Ri Li,Stefano Panni,Mahmut Gümüş,Mustafa Özgüroğlu,Sanjeev Mariathasan,Yekaterina Poloz
出处
期刊:Lancet Oncology [Elsevier BV]
卷期号:25 (1): 46-61 被引量:23
标识
DOI:10.1016/s1470-2045(23)00539-9
摘要

Background The primary analysis of IMvigor130 showed a significant progression-free survival benefit with first-line atezolizumab plus platinum-based chemotherapy (group A) versus placebo plus platinum-based chemotherapy (group C) in patients with locally advanced or metastatic urothelial cancer. However, this finding did not translate into significant overall survival benefit for group A versus group C at the final analysis, precluding formal statistical testing of outcomes with atezolizumab monotherapy (group B) versus group C. Here we report the final overall survival results for group B versus group C; this report is descriptive and should be considered exploratory due to the study's statistical design. Methods In this global, partially blinded, randomised, controlled, phase 3 study, patients (aged ≥18 years) who had locally advanced or metastatic urothelial cancer previously untreated in the metastatic setting and Eastern Cooperative Oncology Group performance status of 0–2 were enrolled at 221 hospitals and oncology centres in 35 countries. Patients were randomly assigned (1:1:1), using a permuted block method (block size of six) and an interactive voice and web response system, stratified by PD-L1 status, Bajorin score, and investigator's choice of platinum-based chemotherapy, to receive either atezolizumab plus platinum-based chemotherapy (group A), atezolizumab alone (group B), or placebo plus platinum-based chemotherapy (group C). Sponsors, investigators, and patients were masked to assignment to atezolizumab or placebo in group A and group C; atezolizumab monotherapy in group B was open label. For groups B and C, atezolizumab (1200 mg) or placebo was administered intravenously every 3 weeks. Chemotherapy involved 21-day cycles of gemcitabine (1000 mg/m2 body surface area on day 1 and day 8 of each cycle) plus the investigator's choice of carboplatin (area under the curve 4·5 mg/mL per min or 5 mg/mL per min) or cisplatin (70 mg/m2 body surface area), administered intravenously. Co-primary endpoints were progression-free survival and overall survival in group A versus group C, and overall survival in group B versus group C, tested hierarchically, in the intention-to-treat (ITT) population, and then the populations with high PD-L1 tumour expression (immune cell [IC] expression score of IC2/3) if the results from group A versus group C were significant. Here, we report the co-primary endpoint of overall survival for group B versus group C in the ITT and IC2/3 populations. The ITT population for this analysis comprised concurrently enrolled patients in groups B and C who were randomly assigned to treatment. For the safety analysis, all patients enrolled in group B and group C who received any study treatment were included. The trial is registered with ClinicalTrials.gov, NCT02807636, and is active but no longer recruiting. Findings Between July 15, 2016, and July 20, 2018, 1213 patients were enrolled and randomly assigned to treatment, of whom 362 patients were assigned to group B and 400 to group C, of whom 360 and 359, respectively, were enrolled concurrently (ITT population). 543 (76%) of 719 patients were male, 176 (24%) were female, and 534 (74%) were White. As of data cutoff (Aug 31, 2022), after a median follow-up of 13·4 months (IQR 6·2–30·8), median overall survival was 15·2 months (95% CI 13·1–17·7; 271 deaths) in group B and 13·3 months (11·9–15·6; 275 deaths) in group C (stratified hazard ratio 0·98 [95% CI 0·82–1·16]). The most common grade 3–4 treatment-related adverse events were anaemia (two [1%] in patients who received atezolizumab monotherapy vs 133 [34%] in those who received placebo plus chemotherapy), neutropenia (one [<1%] vs 115 [30%]), decreased neutrophil count (0 vs 95 [24%]), and decreased platelet count (one [<1%] vs 92 [24%]). Serious adverse events occurred in 163 (46%) patients versus 196 (50%). Treatment-related deaths occurred in three (1%; n=1 each, pneumonia, interstitial lung disease, large intestinal obstruction) patients who received atezolizumab monotherapy and four (1%; n=1 each, diarrhoea, febrile neutropenia, unexplained death, toxic hepatitis) who received placebo plus chemotherapy. Interpretation The final analysis from IMvigor130 did not show a significant improvement in overall survival with first-line atezolizumab monotherapy compared with platinum-based chemotherapy in the intention-to-treat population. The safety profile of atezolizumab monotherapy remained acceptable after extended follow-up, with no new safety signals. Funding F Hoffmann-La Roche.
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
上官若男应助科研通管家采纳,获得30
刚刚
斯文败类应助科研通管家采纳,获得10
刚刚
李爱国应助科研通管家采纳,获得10
刚刚
科研通AI2S应助科研通管家采纳,获得10
刚刚
赘婿应助科研通管家采纳,获得10
刚刚
田様应助精明晓刚采纳,获得10
10秒前
36秒前
精明晓刚发布了新的文献求助10
42秒前
科研通AI2S应助科研通管家采纳,获得10
2分钟前
coolplex完成签到 ,获得积分10
2分钟前
wwe完成签到,获得积分10
2分钟前
貔貅完成签到 ,获得积分10
3分钟前
yindi1991完成签到 ,获得积分10
5分钟前
hgl完成签到,获得积分10
5分钟前
5分钟前
科研通AI2S应助科研通管家采纳,获得10
6分钟前
6分钟前
华仔应助精明晓刚采纳,获得10
6分钟前
6分钟前
7分钟前
精明晓刚发布了新的文献求助10
7分钟前
糖伯虎完成签到 ,获得积分10
7分钟前
在水一方应助科研通管家采纳,获得10
8分钟前
光合作用完成签到,获得积分10
8分钟前
9分钟前
精明晓刚发布了新的文献求助10
9分钟前
精明晓刚完成签到,获得积分10
9分钟前
9分钟前
搜集达人应助kangkang采纳,获得10
9分钟前
英姑应助科研通管家采纳,获得10
10分钟前
kangkang完成签到,获得积分20
10分钟前
10分钟前
刘紫媛发布了新的文献求助10
10分钟前
故意的冰淇淋完成签到 ,获得积分10
11分钟前
刘紫媛完成签到,获得积分20
11分钟前
Lucas应助Dave采纳,获得10
11分钟前
刘紫媛关注了科研通微信公众号
11分钟前
11分钟前
Akitten发布了新的文献求助10
11分钟前
草木完成签到 ,获得积分20
11分钟前
高分求助中
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
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 3990351
求助须知:如何正确求助?哪些是违规求助? 3532158
关于积分的说明 11256513
捐赠科研通 3271046
什么是DOI,文献DOI怎么找? 1805207
邀请新用户注册赠送积分活动 882302
科研通“疑难数据库(出版商)”最低求助积分说明 809234