IMpower210:东亚非小细胞肺癌患者二线治疗atezolizumab与多西他赛的III期研究。

IF 7 2区 医学 Q1 ONCOLOGY Chinese Journal of Cancer Research Pub Date : 2024-04-30 DOI:10.21147/j.issn.1000-9604.2024.02.01
Yi-Long Wu, Shun Lu, Gongyan Chen, Jianxing He, Jifeng Feng, Yiping Zhang, Liyan Jiang, Hongming Pan, Jianhua Chang, Jian Fang, Amy Cai, Lilian Bu, Jane Shi, Jinjing Xia
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引用次数: 0

摘要

研究目的IMpower210(NCT02813785)探讨了单药阿特珠单抗与多西他赛作为东亚患者晚期非小细胞肺癌(NSCLC)二线治疗的有效性和安全性:这项III期开放标签随机研究的主要资格标准包括:年龄≥18岁;根据国际癌症控制联盟/美国癌症联合委员会分期系统(第7版),有组织学记录的晚期NSCLC;东部合作肿瘤学组表现状态为0或1;晚期或转移性NSCLC铂类化疗后疾病进展。患者以2:1的比例随机接受阿特珠单抗(1200毫克)或多西他赛(75毫克/平方米)治疗。主要研究终点是野生型表皮生长因子受体表达(ITT EGFR-WT)的意向治疗(ITT)人群和总体ITT人群的总生存期(OS):ITT EGFR-WT人群(n=467)中,阿特珠单抗治疗组(n=312)的中位OS为12.3个月[95%置信区间(95% CI),10.3-13.8],多西他赛治疗组为9.9个月(95% CI,7.8-13.9)[n=155;分层危险比(HR),0.82;95% CI,0.66-1.03]。在ITT人群中,阿特珠单抗治疗的中位OS为12.5个月(95% CI,10.8-13.8个月),多西他赛治疗的中位OS为11.1个月(95% CI,8.4-14.2个月)(n=377)(n=188;分层HR,0.87;95% CI,0.71-1.08)。阿特珠单抗治疗组18.4%的患者和多西他赛治疗组50.0%的患者发生了3/4级治疗相关不良事件(TRAEs):IMpower210在ITT表皮生长因子受体-WT或总体ITT人群中未达到OS的主要疗效终点。与多西他赛相比,Atezolizumab的耐受性更好,3/4级TRAE发生率更低。
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IMpower210: A phase III study of second-line atezolizumab vs. docetaxel in East Asian patients with non-small cell lung cancer.

Objective: IMpower210 (NCT02813785) explored the efficacy and safety of single-agent atezolizumab vs. docetaxel as second-line treatment for advanced non-small cell lung cancer (NSCLC) in East Asian patients.

Methods: Key eligibility criteria for this phase III, open-label, randomized study included age ≥18 years; histologically documented advanced NSCLC per the Union for International Cancer Control/American Joint Committee on Cancer staging system (7th edition); Eastern Cooperative Oncology Group performance status of 0 or 1; and disease progression following platinum-based chemotherapy for advanced or metastatic NSCLC. Patients were randomized 2:1 to receive either atezolizumab (1,200 mg) or docetaxel (75 mg/m2). The primary study endpoint was overall survival (OS) in the intention-to-treat (ITT) population with wild-type epidermal growth factor receptor expression (ITT EGFR-WT) and in the overall ITT population.

Results: Median OS in the ITT EGFR-WT population (n=467) was 12.3 [95% confidence interval (95% CI), 10.3-13.8] months in the atezolizumab arm (n=312) and 9.9 (95% CI, 7.8-13.9) months in the docetaxel arm [n=155; stratified hazard ratio (HR), 0.82; 95% CI, 0.66-1.03]. Median OS in the overall ITT population was 12.5 (95% CI, 10.8-13.8) months with atezolizumab treatment and 11.1 (95% CI, 8.4-14.2) months (n=377) with docetaxel treatment (n=188; stratified HR, 0.87; 95% CI, 0.71-1.08). Grade 3/4 treatment-related adverse events (TRAEs) occurred in 18.4% of patients in the atezolizumab arm and 50.0% of patients in the docetaxel arm.

Conclusions: IMpower210 did not meet its primary efficacy endpoint of OS in the ITT EGFR-WT or overall ITT populations. Atezolizumab was comparatively more tolerable than docetaxel, with a lower incidence of grade 3/4 TRAEs.

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来源期刊
自引率
9.80%
发文量
1726
审稿时长
4.5 months
期刊介绍: Chinese Journal of Cancer Research (CJCR; Print ISSN: 1000-9604; Online ISSN:1993-0631) is published by AME Publishing Company in association with Chinese Anti-Cancer Association.It was launched in March 1995 as a quarterly publication and is now published bi-monthly since February 2013. CJCR is published bi-monthly in English, and is an international journal devoted to the life sciences and medical sciences. It publishes peer-reviewed original articles of basic investigations and clinical observations, reviews and brief communications providing a forum for the recent experimental and clinical advances in cancer research. This journal is indexed in Science Citation Index Expanded (SCIE), PubMed/PubMed Central (PMC), Scopus, SciSearch, Chemistry Abstracts (CA), the Excerpta Medica/EMBASE, Chinainfo, CNKI, CSCI, etc.
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