Wang Manni, Ma Xuelei, Guo Linghong, Xia Fan
State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
Drug Des Devel Ther. 2017 Sep 27;11:2851-2860. doi: 10.2147/DDDT.S146286. eCollection 2017.
The aim of the present review is to systematically evaluate the efficacy and safety of pembrolizumab by analyzing survival outcomes and at the same time, to present evidence for future clinical applications of anti-programmed cell death protein 1 (anti-PD-1) antibodies by analyzing the efficacy and safety of pembrolizumab.
A comprehensive literature search of PubMed, Medline, and Embase was performed for all relevant clinical trials. In this study, adverse events of any grades and grades ≥3 were summarized and calculated for event rates. For controlled trials, odd ratios (ORs) were calculated to determine the role of pembrolizumab in adverse events. The Kaplan-Meier survival curves were extracted for hazard ratio (HR) calculation and survival outcomes were measured by progression-free survival (PFS).
A total of 3,953 patients were included in safety analyses. The results indicated that the overall incidence of any treatment emergent adverse events was 74.3% (95% confidence interval [CI]: 0.671-0.805). The efficacy analysis involving 915 patients with advanced melanoma suggested that 10 mg/kg of pembrolizumab every 3 weeks could improve patients' PFS (HR =0.73, 95% CI: 0.64-0.83).
Pembrolizumab is a promising therapeutic option that could bring better survival outcomes but, at the same time, leads to higher frequency of some adverse events.
本综述的目的是通过分析生存结果系统评估帕博利珠单抗的疗效和安全性，同时通过分析帕博利珠单抗的疗效和安全性，为抗程序性细胞死亡蛋白1（抗PD - 1）抗体的未来临床应用提供证据。
对PubMed、Medline和Embase进行全面文献检索，查找所有相关临床试验。在本研究中，总结并计算了任何级别和≥3级的不良事件的发生率。对于对照试验，计算比值比（OR）以确定帕博利珠单抗在不良事件中的作用。提取Kaplan - Meier生存曲线用于计算风险比（HR），并通过无进展生存期（PFS）衡量生存结果。
共有3953例患者纳入安全性分析。结果表明，任何治疗中出现的不良事件的总体发生率为74.3%（95%置信区间[CI]：0.671 - 0.805）。对915例晚期黑色素瘤患者的疗效分析表明，每3周给予10mg/kg帕博利珠单抗可改善患者的PFS（HR = 0.73，95%CI：0.64 - 0.83）。
帕博利珠单抗是一种有前景的治疗选择，可带来更好的生存结果，但同时会导致某些不良事件的发生率更高。
