title: Treatment related severe and fatal adverse events with cetuximab in colorectal cancer patients: a meta-analysis.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China.
authors.forename: Di
authors.initials: D
authors.lastname: Zhang
authors.forename: Junjie
authors.initials: J
authors.lastname: Ye
authors.forename: Tangpeng
authors.initials: T
authors.lastname: Xu
authors.forename: Bin
authors.initials: B
authors.lastname: Xiong
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000401:mortality; D006801:Humans; D015994:Incidence; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012306:Risk
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab