Zhang Di, Ye Junjie, Xu Tangpeng, Xiong Bin
Department of Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China.
J Chemother. 2013 Jun;25(3):170-5. doi: 10.1179/1973947813Y.0000000070.
Cetuximab has been approved by FDA for the treatment of advanced/metastatic colorectal cancer. Whether cetuximab treatment is associated with an increase of severe adverse events in colorectal cancer (CRC) patients remains a question. The purpose is to assess the risk of severe adverse events of cetuximab treatment in advanced/metastatic CRC patients.
Search of EMBASE, PubMed, and ScienceDirect between 1 January, 2000 and 1 July 2012 for relevant randomized control trials (RCTs). Previous meta-analyses related with cetuximab treatment were also identified for eligible RCTs. Eligible studies were RCTs of advanced/metastatic CRC patients assigned to cetuximab or control group. Data were extracted by two authors for severe and fatal adverse events.
Nine RCTs, involving 8520 patients with CRC were included. Using a fixed-effects model, the proportion of patients with severe adverse events was higher in the cetuximab group than in control group with Mantel-Haenszel methods (OR, 2·19; 95% CI, 1·99-2·41; incidence, 70·0% versus 51·2%; P<0·001). The most common severe adverse events were neutropenia, diarrhea, and rash. However, cetuximab was not associated with increased risk of fatal adverse events (OR, 1·41; 95% CI, 0·99-2·03; incidence, 1·8% versus. 1·3%).
In this meta-analysis of RCTs, cetuximab was associated with an increased risk of severe adverse events. There is no evidence of an increased risk of fatal adverse events with cetuximab.
西妥昔单抗已获美国食品药品监督管理局（FDA）批准用于治疗晚期/转移性结直肠癌。西妥昔单抗治疗是否会增加结直肠癌（CRC）患者严重不良事件的发生风险仍是一个问题。本研究旨在评估西妥昔单抗治疗晚期/转移性CRC患者严重不良事件的风险。
检索2000年1月1日至2012年7月1日期间EMBASE、PubMed和ScienceDirect数据库中的相关随机对照试验（RCT）。同时检索与西妥昔单抗治疗相关的既往荟萃分析，以获取符合条件的RCT。符合条件的研究为晚期/转移性CRC患者随机分配至西妥昔单抗组或对照组的RCT。由两位作者提取严重和致命不良事件的数据。
纳入9项RCT，共8520例CRC患者。采用固定效应模型，运用Mantel-Haenszel方法分析，西妥昔单抗组严重不良事件患者比例高于对照组（比值比[OR]，2.19；95%置信区间[CI]，1.99 - 2.41；发生率，70.0%对51.2%；P<0.001）。最常见的严重不良事件为中性粒细胞减少、腹泻和皮疹。然而，西妥昔单抗与致命不良事件风险增加无关（OR，1.41；95% CI，0.99 - 2.03；发生率，1.8%对1.3%）。
在这项RCT的荟萃分析中，西妥昔单抗与严重不良事件风险增加相关。没有证据表明西妥昔单抗会增加致命不良事件的风险。
