帕博利珠单抗与纳武利尤单抗治疗非小细胞肺癌的间接比较:一项随机临床试验的荟萃分析

Indirect comparison between pembrolizumab and nivolumab for the treatment of non-small cell lung cancer: A meta-analysis of randomized clinical trials.

作者信息

Peng Tzu-Rong, Tsai Fang-Pei, Wu Ta-Wei

机构信息

Department of Pharmacy, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan.

Department of Pharmacy, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan; School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei City, Taiwan.

出版信息

Int Immunopharmacol. 2017 Aug;49:85-94. doi: 10.1016/j.intimp.2017.05.019. Epub 2017 May 27.

Abstract

OBJECTIVE

The purpose of this study is to evaluate the efficacy and adverse effects of nivolumab and pembrolizumab for the treatment of advanced non-small-cell lung cancer (NSCLC) by meta-analysis.

MATERIALS AND METHODS

This meta-analysis of randomized controlled trials (RCTs) was performed after searching PubMed, EMBASE, and American Society of Clinical Oncology meeting abstracts, clinicaltrial gov, and Cochrane library databases. Two reviewers independently assessed the quality of the trials. Outcomes analysis was overall response rates (ORR), overall survival (OS), progression- free survival (PFS) and major adverse effects with odds ratio (OR) or hazard ratio (HR) and 95% confidence intervals (CI).

RESULTS

Results reported from three RCTs involving 1,887 patients are included in this analysis. Indirect comparison between pembrolizumab and nivolumab in advanced NSCLC shows no statistically significant difference in ORR (OR: 1.14, 95% CI, 0.60-2.01), OS (HR: 0.98, 95% CI, 0.35-2.74) and PFS (HR: 1.12, 95% CI, 0.70-1.77). The incidence of grades≥3 adverse effects is higher with pembrolizumab as compared with nivolumab (OR: 3.44, 95% CI, 1.87-6.32). There are no significant statistical differences between severe adverse effects, such as pneumonitis and hypothyroidism, of the two drugs.

CONCLUSIONS

This study has demonstrated that pembrolizumab and nivolumab have similar survival outcomes in patients with advanced NSCLC, but pembrolizumab has a higher incidence of grades≥3 adverse effects than nivolumab.

摘要

目的

本研究旨在通过荟萃分析评估纳武利尤单抗和帕博利珠单抗治疗晚期非小细胞肺癌(NSCLC)的疗效和不良反应。

材料与方法

在检索PubMed、EMBASE、美国临床肿瘤学会会议摘要、clinicaltrial gov和Cochrane图书馆数据库后,进行了这项随机对照试验(RCT)的荟萃分析。两名 reviewers 独立评估试验质量。结果分析包括总缓解率(ORR)、总生存期(OS)、无进展生存期(PFS)以及具有优势比(OR)或风险比(HR)和95%置信区间(CI)的主要不良反应。

结果

本分析纳入了三项涉及1887例患者的RCT报告的结果。帕博利珠单抗和纳武利尤单抗在晚期NSCLC中的间接比较显示,ORR(OR:1.14,95%CI,0.60 - 2.01)、OS(HR:0.98,95%CI,0.35 - 2.74)和PFS(HR:1.12,95%CI,0.70 - 1.77)无统计学显著差异。与纳武利尤单抗相比,帕博利珠单抗≥3级不良反应的发生率更高(OR:3.44,95%CI,1.87 - 6.32)。两种药物的严重不良反应,如肺炎和甲状腺功能减退,之间无显著统计学差异。

结论

本研究表明,帕博利珠单抗和纳武利尤单抗在晚期NSCLC患者中的生存结果相似,但帕博利珠单抗≥3级不良反应的发生率高于纳武利尤单抗。

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