Efficacy and safety of bevacizumab biosimilar compared with reference bevacizumab in locally advanced and advanced non-small cell lung cancer patients: A retrospective study.
Efficacy and safety of bevacizumab biosimilar compared with reference bevacizumab in locally advanced and advanced non-small cell lung cancer patients: A retrospective study.
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贝伐珠单抗生物仿制药与参比贝伐珠单抗在局部晚期和晚期非小细胞肺癌患者中的疗效和安全性：一项回顾性研究
DOI：
10.3389/fonc.2022.1036906
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发表时间：
2022
影响因子：
4.7
通讯作者：
中科院分区：
文献类型：
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作者：
贝伐单抗在无基因突变的晚期非小细胞肺癌（NSCLC）患者的全身治疗中发挥了重要作用。近年来，贝伐珠单抗生物类似药已根据III期临床研究结果获得上市批准。但贝伐珠单抗生物类似药在临床应用中的有效性和安全性还需要更多的临床数据来验证。我们确定了2019年1月1日至2021年11月30日期间接受贝伐珠单抗生物仿制药或贝伐珠单抗治疗的946例局部晚期或转移性NSCLC患者。对贝伐珠单抗生物类似药和贝伐珠单抗的疗效和安全性进行比较和统计分析。直接根据RECIST v1.1进行疗效评价。根据美国国家癌症研究所不良事件通用术语标准v5.0对不良事件进行分级。生物类似药组（n=551）的客观缓解率（ORR）为28.9%，参比组为30.9%（n=395;未分层ORR风险比：0.934，95%置信区间[CI]：0.677-1.138;未分层ORR风险差：−0.020，95% CI：−0.118-0.035）。生物类似药组和参比药物组的估计中位无进展生存期（mPFS）分别为6.27（95% CI：5.53-7.01）和4.93（95% CI：4.24-5.62）个月（P=0.296）。治疗线数、联合治疗方案、有无放疗是影响两组PFS的显著因素（P<0.001，P=0.001，P=0.039）。不同基因突变和剂量强度不是影响PFS的主要因素（P=0.627，P=0.946）。生物类似药组治疗后出现的不良事件（TEAE）发生率为76.41%，参比药物组为71.65%（P=0.098）。生物类似药组和参比药物组3级或以上TEAE的发生率分别为22.14%和19.49%（P=0.324）。贝伐珠单抗生物仿制药在局部晚期和晚期NSCLC患者中的疗效与贝伐珠单抗相当。它显示出可接受的毒性特征，没有新的不良事件。被临床试验排除的患者也可以从贝伐珠单抗生物类似药中获益。
Bevacizumab has played an important role in the systemic treatment of patients with advanced non-small-cell lung cancer (NSCLC) without gene mutation. In recent years, bevacizumab biosimilar has received marketing approval based on the results of phase III clinical studies. However, more clinical data are needed to verify the efficacy and safety of bevacizumab biosimilar in clinical application. We identified 946 patients with locally advanced or metastatic NSCLC who were treated with bevacizumab biosimilar or bevacizumab from January 1, 2019 to November 30, 2021. Comparisons and statistical analyses of bevacizumab biosimilar and bevacizumab were made in terms of efficacy and safety. Efficacy evaluation was performed directly in accordance with RECIST v1.1. Adverse events were graded following the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. The objective response rates (ORRs) were 28.9% in the biosimilar group (n=551) and 30.9% in the reference group (n=395; unstratified ORR risk ratio: 0.934, 95% confidence interval [CI]: 0.677–1.138; unstratified ORR risk difference: −0.020, 95% CI: −0.118–0.035). The estimated median progression-free survival (mPFS) were 6.27 (95% CI: 5.53–7.01) and 4.93 (95% CI: 4.24–5.62) months in the biosimilar and reference groups, respectively (P=0.296). The number of treatment lines, combined treatment regimens and with or without radiotherapy were significant factors affecting the PFS of both groups (P<0.001, P=0.001, P=0.039). Different genetic mutations and dose intensity were not the main factors affecting PFS (P=0.627, P=0.946). The incidences of treatment-emergent adverse events (TEAEs) were 76.41% in the biosimilar group and 71.65% in the reference group (P=0.098). The incidences of grade 3 or higher TEAEs were 22.14% and 19.49% in the biosimilar and reference groups, respectively (P=0.324). Bevacizumab biosimilar is equivalent in efficacy to bevacizumab in patients with locally advanced and advanced NSCLC. It showed acceptable toxicity profile and no new adverse events. Patients who were excluded by clinical trials can also benefit from bevacizumab biosimilar.
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DOI：
10.1093/annonc/mdq020
发表时间：
2010-09
期刊：
Annals of oncology : official journal of the European Society for Medical Oncology
影响因子：
--
作者：
Reck M;von Pawel J;Zatloukal P;Ramlau R;Gorbounova V;Hirsh V;Leighl N;Mezger J;Archer V;Moore N;Manegold C;BO17704 Study Group
通讯作者：
BO17704 Study Group
影响因子：
5.8
作者：
Cohen, Martin H.;Gootenberg, Joe;Pazdur, Richard
通讯作者：
Pazdur, Richard
影响因子：
6.8
作者：
Reinmuth, Niels;Bryl, Maciej;Kasahara, Kazuo
通讯作者：
Kasahara, Kazuo
影响因子：
5.3
作者：
Reck，Martin;Luft，Alexander;Shin，Donghoon
通讯作者：
Shin，Donghoon
美国首个治疗性肿瘤生物仿制药贝伐单抗-awwb 和曲妥珠单抗-anns 治疗患者的临床和治疗特征。
影响因子：
4.9
作者：
Jin R;Mahtani RL;Accortt N;Lawrence T;Sandschafer D;Loaiza-Bonilla A
通讯作者：
Loaiza-Bonilla A