Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12)

医学 吉西他滨 内科学 双盲 安慰剂 肿瘤科 随机对照试验 化疗 病理 替代医学
作者
Caicun Zhou,Lin Wu,Yun Fan,Zhehai Wang,Lianke Liu,Gongyan Chen,Li Zhang,Dingzhi Huang,Shundong Cang,Zhixiong Yang,Jianying Zhou,Chengzhi Zhou,Baolan Li,Juan Li,Min Fan,Jiuwei Cui,Yuping Li,Hui Zhao,Jian Fang,Jianxin Xue
出处
期刊:Journal of Thoracic Oncology [Elsevier BV]
卷期号:16 (9): 1501-1511 被引量:224
标识
DOI:10.1016/j.jtho.2021.04.011
摘要

IntroductionThe standard chemotherapy for squamous NSCLC (sqNSCLC) includes platinum plus gemcitabine. Sintilimab, an anti–programmed cell death protein 1 antibody, plus platinum and gemcitabine (GP) has revealed encouraging efficacy as first-line therapy for sqNSCLC in a phase 1b study. We conducted a randomized, double-blind, phase 3 study to further compare the efficacy and safety of sintilimab with placebo, both in combination with GP.MethodsORIENT-12, a randomized, double-blind, phase 3 study, was conducted at 42 centers in the People’s Republic of China (ClinicalTrials.gov, number NCT03629925). Patients with locally advanced or metastatic sqNSCLC and without EGFR-sensitive mutations or ALK rearrangements were enrolled in the study. The stratification factors included clinical stage, choice of platinum, and programmed death-ligand 1 tumor proportion score. The patients, investigators, research staff, and sponsor team were masked to treatment assignment. Eligible patients were randomized 1:1, using an integrated web-response system, to receive sintilimab 200 mg or placebo plus GP every 3 weeks for four or six cycles, followed by sintilimab or placebo as maintenance therapy until disease progression or 2 years. The primary end point was progression-free survival (PFS), assessed by an independent radiographic review committee.ResultsBetween September 25, 2018 and July 26, 2019, a total of 543 patients were screened, of whom 357 patients were randomized to the sintilimab-GP group (n = 179) and the placebo-GP group (n = 178). After a median follow-up period of 12.9 months, sintilimab-GP continued to reveal a meaningful improvement in PFS than placebo-GP (hazard ratio = 0.536 [95% confidence interval: 0.422–0.681], p < 0.00001). Treatment-emergent adverse events of grade 3 or worse occurred in 86.6% patients in the sintilimab-GP group and in 83.1% in the placebo-GP group. The incidence of treatment-emergent adverse event leading to death was 4.5% and 6.7% in the two treatment groups, respectively.ConclusionsRegarding PFS, sintilimab plus GP reveals clinical benefit than GP alone as first-line therapy in patients with locally advanced or metastatic sqNSCLC. The toxicity was acceptable, and no new unexpected safety signals were observed.
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
桃紫完成签到,获得积分10
1秒前
小董不懂完成签到,获得积分10
2秒前
椰子完成签到,获得积分10
2秒前
沐沐溪三清完成签到,获得积分10
2秒前
3秒前
刘丰完成签到 ,获得积分10
5秒前
郑桂庆完成签到 ,获得积分10
6秒前
zhang完成签到 ,获得积分10
6秒前
yuchen完成签到,获得积分10
7秒前
喜悦的水云完成签到 ,获得积分10
7秒前
8秒前
zhaokunfeng完成签到,获得积分10
8秒前
Y123发布了新的文献求助10
8秒前
wu完成签到,获得积分10
8秒前
高高诗柳完成签到 ,获得积分10
8秒前
王金豪完成签到,获得积分10
8秒前
LSS完成签到,获得积分10
8秒前
榜一大哥的负担完成签到 ,获得积分10
9秒前
Lucas应助qi0625采纳,获得10
9秒前
顾矜应助以筱采纳,获得10
10秒前
景清完成签到,获得积分10
10秒前
细心香烟完成签到 ,获得积分10
10秒前
hu完成签到 ,获得积分10
10秒前
HQ完成签到,获得积分10
10秒前
11秒前
水清木华完成签到,获得积分10
11秒前
12秒前
miao完成签到,获得积分20
12秒前
xyp_zjut应助学术乞丐采纳,获得10
12秒前
Lucas应助凉白开采纳,获得10
12秒前
体贴凌柏发布了新的文献求助10
13秒前
13秒前
13秒前
鹿子完成签到 ,获得积分10
13秒前
秋枫忆完成签到,获得积分10
15秒前
宋立发布了新的文献求助10
15秒前
孤独的AD钙完成签到,获得积分10
15秒前
16秒前
fang应助miao采纳,获得10
17秒前
星辰与月完成签到,获得积分10
17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 4038368
求助须知:如何正确求助?哪些是违规求助? 3576068
关于积分的说明 11374313
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