Efficacy, Safety, and Health-Related Quality of Life With Camrelizumab Plus Pemetrexed and Carboplatin as First-Line Treatment for Advanced Nonsquamous NSCLC With Brain Metastases (CAP-BRAIN): A Multicenter, Open-Label, Single-Arm, Phase 2 Study

医学 培美曲塞 卡铂 内科学 实体瘤疗效评价标准 肿瘤科 临床终点 化疗 无进展生存期 临床研究阶段 外科 临床试验 顺铂
作者
Xue Hou,Chengzhi Zhou,Guowu Wu,Lin Wen,Zhanhong Xie,Haibo Zhang,Jiqun Yi,Peng Zheng,Lifeng Yin,Chi Ma,Likun Chen
出处
期刊:Journal of Thoracic Oncology [Elsevier BV]
卷期号:18 (6): 769-779 被引量:33
标识
DOI:10.1016/j.jtho.2023.01.083
摘要

Systemic treatment options for NSCLC with brain metastases (BMs) are scarce. We evaluated the activity and safety of camrelizumab plus chemotherapy as first-line therapy in patients with advanced nonsquamous NSCLC with BMs. This was a multicenter, single-arm, phase 2 trial (NCT04211090) conducted at seven hospitals in China. Eligible patients had treatment-naive metastatic nonsquamous NSCLC and BMs that were asymptomatic or symptoms controlled with dehydration therapy and no previous systemic treatment or local therapy for the target brain lesion. Patients received camrelizumab (200 mg) plus pemetrexed (500 mg/m2) and carboplatin (area under the curve 5) intravenously on day 1 of each 21-day cycle for four cycles, followed by maintenance with camrelizumab (200 mg) and pemetrexed (500 mg/m2) every 21 days until disease progression, unacceptable toxicity, or death. The primary end point was confirmed intracranial objective response rate according to modified Response Evaluation Criteria in Solid Tumors version 1.1, which was primarily analyzed in the efficacy analysis set (EAS). A total of 45 patients were enrolled and treated (full analysis set), with 40 patients having at least one post-baseline tumor assessment (EAS). As of August 30, 2022, median follow-up duration was 12.5 months (95% confidence interval [CI]: 9.2-17.3). The confirmed intracranial objective response rate was 52.5% (95% CI: 36.1-68.5) in EAS and 46.7% (95% CI: 31.7-62.1) in full analysis set. The extracranial objective response rate was 47.5% (95% CI: 31.5-63.9) and 42.2% (95% CI: 27.7-57.8), respectively. Median intracranial progression-free survival was 7.6 months (95% CI: 4.6-not reached [NR]), median overall progression-free survival was 7.4 months (95% CI: 4.4-NR), and median overall survival was 21.0 months (95% CI: 15.9-NR). The most common treatment-related adverse events of grade 3 or higher were neutrophil count decrease (six [13.3%]) and anemia (four [8.9%]). One treatment-related death occurred owing to immune-related pneumonia. Linear mixed-effects model displayed that a positive trend for improvement in cognitive function and quality of life was observed based on Montreal Cognitive Assessment and Functional Assessment of Cancer Therapy-Lung scores (p = 0.025, p < 0.001). Camrelizumab plus pemetrexed and carboplatin was found to have an activity with manageable toxicity and to improve cognitive function and quality of life for patients with nonsquamous NSCLC with BMs in the first-line setting.
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
愫浅完成签到 ,获得积分10
2秒前
蓝桉完成签到 ,获得积分10
3秒前
琉璃完成签到 ,获得积分10
7秒前
徐佳达完成签到,获得积分10
7秒前
8秒前
银海里的玫瑰_完成签到 ,获得积分10
8秒前
11秒前
努力学地理的小菜鸡完成签到,获得积分10
13秒前
小圆圈发布了新的文献求助10
15秒前
非对称转录完成签到,获得积分0
16秒前
fifteen发布了新的文献求助10
17秒前
文献狗完成签到,获得积分10
22秒前
摆哥完成签到,获得积分10
26秒前
浮尘完成签到 ,获得积分0
26秒前
骄阳完成签到 ,获得积分10
32秒前
黄天完成签到 ,获得积分10
35秒前
单纯的小土豆完成签到,获得积分10
37秒前
qiqi完成签到,获得积分10
39秒前
善良紫完成签到,获得积分10
41秒前
内向白开水完成签到,获得积分10
42秒前
十月天秤完成签到,获得积分0
43秒前
zhangfuchao完成签到,获得积分10
48秒前
东北饿霸完成签到,获得积分10
48秒前
qqqqq完成签到,获得积分10
48秒前
49秒前
123完成签到 ,获得积分10
50秒前
英姑应助xiaowei666采纳,获得30
53秒前
飞雪完成签到,获得积分10
57秒前
甜甜秋完成签到 ,获得积分10
57秒前
1分钟前
在水一方应助陶醉的笑槐采纳,获得10
1分钟前
ljx完成签到 ,获得积分10
1分钟前
Erich完成签到 ,获得积分10
1分钟前
coolru完成签到,获得积分10
1分钟前
shyxia完成签到 ,获得积分10
1分钟前
1分钟前
熠霖应助Xu采纳,获得10
1分钟前
唐禹嘉完成签到 ,获得积分10
1分钟前
xybjt完成签到 ,获得积分10
1分钟前
简奥斯汀完成签到 ,获得积分10
1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 500
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 3965780
求助须知:如何正确求助?哪些是违规求助? 3511014
关于积分的说明 11156016
捐赠科研通 3245496
什么是DOI,文献DOI怎么找? 1793089
邀请新用户注册赠送积分活动 874230
科研通“疑难数据库(出版商)”最低求助积分说明 804255