目的 对替雷利珠单抗治疗鳞状非小细胞肺癌进行临床综合评价,为临床用药决策提供证据支持.方法 检索中国知网、万方数据、维普网、中国生物医学数据库、Pubmed、Cochrane Library、Web of science数据库关于替雷利珠单抗治疗鳞状非小细胞肺癌的系统评价/Meta分析、药物经济学研究,检索时间从建库至2024年03月1日公开发表的文献.对纳入的4篇文献,采用AMSTAR量表和CHEERS量表进行文献质量评价.基于循证证据定性描述替雷利珠单抗治疗sq-NSCLC有效性、安全性、经济性、创新性、适宜性和可及性.结果 有效性方面:替雷利珠单抗作为一线治疗药物,其客观缓解率为72.5%~74.8%,无进展生存期的中位时间为7.6个月,两方面均优于信迪利单抗、帕博利珠单抗和阿替利珠单抗;舒格利单抗和卡瑞利珠单抗在延长PFS方面优于替雷利珠单抗.作为二线治疗药物替雷利珠单抗在延长患者总生存期的中位时间为17.2个月,效果优于纳武利尤单抗.安全性方面:替雷利珠单抗在一线治疗中≥3级AEs发生率为83.9%~85.8%,低于阿替利珠单抗,高于帕博利珠单抗、信迪利单抗、舒格利单抗和卡瑞利珠单抗.经济性方面:基于中国卫生体系角度,替雷利珠单抗作为一线治疗药物的成本-效益优于信迪利单抗、舒格利单抗、帕博利珠单抗,不如卡瑞利珠单抗;作为二线治疗药物,替雷利珠单抗优于纳武利尤单抗.替雷利珠单抗创新性较好,药品适宜性和可及性与其他药物相当.结论 替雷利珠单抗治疗鳞状非小细胞肺癌安全有效;具有良好经济学优势;作为我国自主研发的一类新药,创新性强,药品技术及使用特点适宜;目前的可获得性尚处于较低水平,但可负担性好.
Comprehensive Clinical Evaluation of Tislelizumab in the Treatment of Squamous Non-small Cell Lung Cancer
Objectives This study aims to comprehensively evaluate the clinical efficacy of Tislelizumab in the treatment of Squamous Non-Small Cell Lung Cancer,and to provide evidence for clinical drug decision.Methods The CNKI,Wanfang Data,VIP,China Biomedical Database,Pubmed,Cochrane Library,and Web of Science databases for systematic reviews/meta-analyses and pharmacoeconomic studies on Tislelizumab for the treatment of squamous non-small cell lung cancer were retrieved.The retrieval time was from the establishment of the database to the publicly published literature on March 1,2024.The quality of the four included articles was evaluated using the AMSTAR and CHEERS scales.The effectiveness,safety,cost-effectiveness,innovation,suitability and accessibility of Tislelizumab in the treatment of sq-NSCLC were qualitatively described based on evidence.Results In terms of effectiveness,as a first-line treatment drug,Tislelizumab had an objective response rate of 72.5%-74.8%and a median progression-free survival of 7.6 months,both of which were superior to Sintilimab,Pembrolizumab and Atezolizumab;Sugemalimab and Camrelizumab were superior to Tislelizumab in prolonging PFS.As a second-line treatment drug,Tislelizumab extended patients'median overall survival by 17.2 months,which was better than nivolumab.In terms of safety,the incidence of grade ≥3 AEs of Tislelizumab in first-line treatment was 83.9%-85.8%,which was lower than that of Atezolizumab,and higher than that of Pembrolizumab,Sintilimab,Sugemalimab,and Carrelizumab.In terms of economics,based on the perspective of China's health system,the cost-effectiveness of Tislelizumab as a first-line treatment drug was superior to Sintilimab,Sugemalimab,and Pembrolizumab,but not as good as Carrelizumab.As a second-line treatment drug,Tislelizumab was superior to Nivolumab.Tislelizumab had good innovation,and its drug suitability and accessibility were comparable to other drugs.Conclusions Tislelizumab is safe and effective in treating squamous non-small cell lung cancer.It has good economic advantages.As a new type of drug independently developed in our country,it is highly innovative,and the drug technology and usage characteristics are appropriate.Its current availability is still at a low level,but it is affordable.
TislelizumabSquamous non-small cell lung cancerClinical comprehensive evaluation of drugImmune check point inhibitors