QL1101和贝伐单抗在非鳞状非小细胞肺癌患者中的等效疗效评估:两年随访数据更新

IF 7 2区医学 Q1 ONCOLOGY

Chinese Journal of Cancer Research Pub Date : 2022-02-28 DOI:10.21147/j.issn.1000-9604.2022.01.03

Jun Lu, T. Chu, Hongyu Liu, Min-juan Hu, Y. Lou, Yanwei Zhang, Zhi-qiang Gao, Wei Zhang, Xueyan Zhang, Huimin Wang, H. Zhong, B. Han

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引用次数: 4

摘要

目的抗血管内皮生长因子(VEGF)单克隆抗体是治疗非小细胞肺癌(NSCLC)的有效手段。在这里，我们的目标是基于两年随访数据更新QL1101和贝伐单抗之间的等效疗效评估。方法本随机对照试验共纳入535例符合条件的非小细胞肺癌患者。患者按1:1的比例随机分配到QL1101组和贝伐单抗组。本研究的完整结束时间定义为最后一名入组患者随机化后的24个月。主要终点为客观缓解率(ORR);如果相对风险的双侧90%置信区间(90% CI)在0.75 - 1.33范围内，则确认等效性。次要终点是无进展生存期(PFS)和总生存期(OS)。结果两年更新的数据显示相似的ORR (QL1101 vs.贝伐单抗:53.1% vs. 54.3%;相对危险度= 0.977;QL1101组和贝伐单抗组之间的90% CI: 0.838−1.144)、PFS (235 d vs. 254 d, log-rank P=0.311)和OS (577 d vs. 641 d, log-rank P=0.099)结果。QL1101组和贝伐单抗组的目标病灶平均收缩率也相似(22.5% vs 23.5%)。对于接受QL1101维持治疗的患者，QL1101组(n=157)和贝伐单抗组(n=148)的结果相似(PFS: 253 d vs 272 d, log-rank P=0.387;OS: 673 d vs. 790 d, log-rank P=0.101;平均肿瘤收缩率:26.6% vs. 27.5%)。结论本研究基于2年更新数据，报告了QL1101治疗非鳞状NSCLC在ORR、PFS和OS方面具有相似的疗效，为QL1101的临床应用提供了依据。

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Equivalent efficacy assessment of QL1101 and bevacizumab in nonsquamous non-small cell lung cancer patients: A two-year follow-up data update

Objective Anti-vascular endothelial growth factor (VEGF) monoclonal antibodies are an effective means of treating non-small cell lung cancer (NSCLC). Here, we aim to update the equivalent efficacy assessment between QL1101 and bevacizumab based on two-year follow-up data. Methods In total, 535 eligible NSCLC patients were enrolled in this randomized controlled trial. Patients were randomly assigned 1:1 to the QL1101 group and the bevacizumab group. The full end time of this study was defined as 24 months after the last enrolled patient was randomized. The primary endpoint was the objective response rate (ORR); equivalence was confirmed if the two-sided 90% confidence interval (90% CI) of the relative risk was within the range of 0.75−1.33. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Results The two-year updated data showed similar ORR (QL1101 vs. bevacizumab: 53.1% vs. 54.3%; relative risk=0.977; 90% CI: 0.838−1.144), PFS (235 d vs. 254 d, log-rank P=0.311), and OS (577 d vs. 641 d, log-rank P=0.099) results between the QL1101 group and the bevacizumab group. The mean shrinkage ratio of targeted lesions was also similar between the QL1101 group and the bevacizumab group (22.5% vs. 23.5%). For patients who received QL1101 maintenance therapy, similar results were shown between the QL1101 group (n=157) and the bevacizumab group (n=148) (PFS: 253 d vs. 272 d, log-rank P=0.387; OS: 673 d vs. 790 d, log-rank P=0.101; mean tumor shrinkage rate: 26.6% vs. 27.5%). Conclusions This study reported that QL1101 had similar efficacy in treating nonsquamous NSCLC in terms of ORR, PFS and OS based on two-year updated data, providing a basis for the clinical application of QL1101.

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来源期刊

Chinese Journal of Cancer Research 医学-肿瘤学

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.