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!

Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer

医学 内科学 化疗 拓扑替康 置信区间 卵巢癌 优势比 肿瘤科 随机化 无进展生存期 随机对照试验 卡铂 外科 胃肠病学 癌症 顺铂
作者
Kathleen N. Moore,Antoine Angelergues,Gottfried E. Konecny,Yolanda García García,Susana Banerjee,Domenica Lorusso,Jung‐Yun Lee,John W. Moroney,Nicoletta Colombo,A. Roszak,Jacqueline M. Tromp,Tashanna Myers,Jeong‐Won Lee,Mario Beiner,Casey Cosgrove,David Cibula,Lainie P. Martin,Renaud Sabatier,Joseph Buscema,Purificación Estévez-García
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:389 (23): 2162-2174 被引量:136
标识
DOI:10.1056/nejmoa2309169
摘要

Mirvetuximab soravtansine-gynx (MIRV), a first-in-class antibody-drug conjugate targeting folate receptor α (FRα), is approved for the treatment of platinum-resistant ovarian cancer in the United States.We conducted a phase 3, global, confirmatory, open-label, randomized, controlled trial to compare the efficacy and safety of MIRV with the investigator's choice of chemotherapy in the treatment of platinum-resistant, high-grade serous ovarian cancer. Participants who had previously received one to three lines of therapy and had high FRα tumor expression (≥75% of cells with ≥2+ staining intensity) were randomly assigned in a 1:1 ratio to receive MIRV (6 mg per kilogram of adjusted ideal body weight every 3 weeks) or chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary end point was investigator-assessed progression-free survival; key secondary analytic end points included objective response, overall survival, and participant-reported outcomes.A total of 453 participants underwent randomization; 227 were assigned to the MIRV group and 226 to the chemotherapy group. The median progression-free survival was 5.62 months (95% confidence interval [CI], 4.34 to 5.95) with MIRV and 3.98 months (95% CI, 2.86 to 4.47) with chemotherapy (P<0.001). An objective response occurred in 42.3% of the participants in the MIRV group and in 15.9% of those in the chemotherapy group (odds ratio, 3.81; 95% CI, 2.44 to 5.94; P<0.001). Overall survival was significantly longer with MIRV than with chemotherapy (median, 16.46 months vs. 12.75 months; hazard ratio for death, 0.67; 95% CI, 0.50 to 0.89; P = 0.005). During the treatment period, fewer adverse events of grade 3 or higher occurred with MIRV than with chemotherapy (41.7% vs. 54.1%), as did serious adverse events of any grade (23.9% vs. 32.9%) and events leading to discontinuation (9.2% vs. 15.9%).Among participants with platinum-resistant, FRα-positive ovarian cancer, treatment with MIRV showed a significant benefit over chemotherapy with respect to progression-free and overall survival and objective response. (Funded by ImmunoGen; MIRASOL ClinicalTrials.gov number, NCT04209855.).
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
黑白完成签到 ,获得积分10
1分钟前
2分钟前
Qian完成签到 ,获得积分10
2分钟前
情怀应助Ying采纳,获得20
2分钟前
2分钟前
2分钟前
科研通AI5应助忧虑的安青采纳,获得10
2分钟前
juejue333完成签到,获得积分10
3分钟前
3分钟前
3分钟前
Ying发布了新的文献求助20
3分钟前
3分钟前
Betty发布了新的文献求助10
3分钟前
Betty完成签到,获得积分10
4分钟前
科目三应助科研通管家采纳,获得10
4分钟前
科研通AI2S应助科研通管家采纳,获得10
4分钟前
SciGPT应助科研通管家采纳,获得10
4分钟前
笨笨完成签到,获得积分10
4分钟前
4分钟前
4分钟前
思源应助嘿嘿嘿侦探社采纳,获得10
4分钟前
5分钟前
5分钟前
5分钟前
gyh发布了新的文献求助10
5分钟前
孤独的涵柳完成签到 ,获得积分10
5分钟前
5分钟前
gyh完成签到,获得积分20
5分钟前
5分钟前
科研通AI2S应助科研通管家采纳,获得30
6分钟前
Owen应助科研通管家采纳,获得10
6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
6分钟前
6分钟前
搜集达人应助喜欢对你笑采纳,获得10
6分钟前
隐形曼青应助科研通管家采纳,获得10
8分钟前
科研通AI2S应助科研通管家采纳,获得10
8分钟前
老石完成签到 ,获得积分10
9分钟前
9分钟前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
Cognitive Neuroscience: The Biology of the Mind 1000
Technical Brochure TB 814: LPIT applications in HV gas insulated switchgear 1000
Immigrant Incorporation in East Asian Democracies 600
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
A Preliminary Study on Correlation Between Independent Components of Facial Thermal Images and Subjective Assessment of Chronic Stress 500
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 3968504
求助须知:如何正确求助?哪些是违规求助? 3513278
关于积分的说明 11167214
捐赠科研通 3248660
什么是DOI,文献DOI怎么找? 1794386
邀请新用户注册赠送积分活动 875030
科研通“疑难数据库(出版商)”最低求助积分说明 804638