Wang Liang, Liu Yagang, Zhou Wenyong, Li Wei
Department of General Surgery, The Central Cangzhou Hospital, Cangzhou, Hebei Province, People's Republic of China.
Onco Targets Ther. 2017 Apr 26;10:2281-2287. doi: 10.2147/OTT.S110431. eCollection 2017.
To perform a systematic review and meta-analysis of Phase III randomized controlled trials (RCTs) to determine the incidence and risk of severe adverse events (AEs) with molecular targeted agents (MTAs) in advanced/metastatic gastric cancer (GC) patients.
A comprehensive literature search for related trials published up to December 2015 was performed. Eligible studies were Phase III RCTs of advanced/metastatic GC patients assigned to MTAs or control group. Data were extracted by two authors for severe and fatal AEs (FAEs).
A total of nine Phase III RCTs involved 4,934 GC patients were ultimately identified. The pooled results demonstrated that the addition of TAs to therapies in advanced GC significantly increased the risk of developing severe AEs (relative risk: 1.12, 95% confidence interval: 1.02-1.24, =0.02), but not for FAEs (relative risk: 0.97, 95% confidence interval: 0.65-1.45, =0.88). Additionally, the most common causes of FAEs with MTAs were infections (16.3%), gastrointestinal hemorrhage (8.2%), and arterial thromboembolic events (8.2%), respectively.
With available evidence, the use of TAs in GC patients was associated with an increased risk of severe AEs, but not for FAE. Clinicians should be aware of the risk of severe AEs with the administration of these drugs in these patients.
对III期随机对照试验（RCT）进行系统评价和荟萃分析，以确定晚期/转移性胃癌（GC）患者使用分子靶向药物（MTA）后严重不良事件（AE）的发生率和风险。
对截至2015年12月发表的相关试验进行全面文献检索。符合条件的研究为晚期/转移性GC患者分配到MTA组或对照组的III期RCT。由两名作者提取严重和致命不良事件（FAE）的数据。
最终确定了9项III期RCT，共涉及4934例GC患者。汇总结果表明，在晚期GC治疗中添加TA显著增加了发生严重AE的风险（相对风险：1.12，95%置信区间：1.02-1.24，P=0.02），但对FAE无显著影响（相对风险：0.97，95%置信区间：0.65-1.45，P=0.88）。此外，MTA导致FAE的最常见原因分别是感染（16.3%）、胃肠道出血（8.2%）和动脉血栓栓塞事件（8.2%）。
根据现有证据，GC患者使用TA与严重AE风险增加相关，但与FAE无关。临床医生应意识到在这些患者中使用这些药物会有严重AE的风险。
