Meta-analysis of efficacy ，safety and immunogenicity of bevacizumab biosimilars and original drugs for patients with non-small cell lung cancer / 中国药房

ABSTRACT

OBJECTIVE To compare the efficacy ，safety and immunogenicity of bevacizumab biosimilars and original drugs for non-small cell lung cancer （NSCLC），and to provide evidence-based reference for clinical use. METHODS PubMed，Embase， Web of Science ，Cochrane Library ，CBM，CNKI，VIP，Wanfang database ，ClinicalTrials.gov，and Clinical Trial Center of China were searched from the establishment of the database to September 25，2021，randomized controlled trials （RCTs）about bevacizumab biosimilars（trial group ）versus bevacizumab original drugs （control group ）for NSCLC were collected. After literature screening ， data extraction and quality evaluation of included RCTs with bias risk assessment tool recommended by Cochrane Handbook 5.1.0， meta-analysis，sensitivity analysis and publication bias analysis were performed by using RevMan 5.3 software. RESULTS A total of 11 RCTs were included ，involving 6 596 patients in total. Meta-analysis showed that there was no statistical significance in the difference of overall response rate [RR＝0.97，95％CI（0.92，1.02），P＝0.22]，the total incidence of adverse reaction [RR＝1.00， 95％CI（0.99，1.01），P＝0.79]，the incidence of severe adverse reaction [RR＝1.04，95％CI（0.96，1.13），P＝0.38]，positive rate of anti-drug antibody [RR ＝1.10，95％CI（0.88，1.36，P＝0.41] and the incidence of common adverse reactions （except for vomiting）among 2 groups（P＞0.05）. The sensitivity analysis results showed that the obtained results were robust. The results of publication bias analysis showed that there was little possibility of publication bias. CONCLUSIONS The efficacy ，safety and immunogenicity of bevacizumab biosimilars used for NSCLC are equivalent to those of bevacizumab original drugs.