Treatment related severe and fatal adverse events with cetuximab in colorectal
cancer patients: a meta-analysis.
Author(s): Zhang D(1), Ye J, Xu T, Xiong B.
Affiliation(s): Author information:
(1)Department of Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China.
Publication date & source: 2013, J Chemother. , 25(3):170-5
PURPOSE: 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.
PATIENTS AND 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%).
CONCLUSION: 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.
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