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Background  Epidermal growth factor receptor gene copy number ( EGFR  GCN) has been heavily investigated as a potential predictive biomarker for the treatment of metastatic colorectal cancer (mCRC) with anti-EGFR monoclonal antibodies (MAbs). The objective of this study was to systematically review current evidences on this issue.    Methods  PubMed, EMBASE, The Cochrane Library, Chinese Biomedical Literature Database, Wanfang Data, and the conference abstracts of American Society of Clinical Oncology and European Society of Medical Oncology were comprehensively searched. Studies that reported the objective response rate (ORR), progression-free survival, and/or overall survival of mCRC patients treated with anti-EGFR MAbs, stratified by  EGFR  GCN status, were included. The effect measures for binary outcome (response) and time-to-event outcomes (progression-free survival and overall survival) were risk difference and hazard ratio, respectively. Statistical heterogeneity among the studies was assessed by the Cochran’s  Q -test and the  I  2  statistic. If appropriate, a quantitative synthesis of data from different studies would be conducted with a random-effects model.    Results  Nineteen eligible studies were identified. The criteria for increased  EGFR  GCN (GCN+) were highly inconsistent across different studies. The prevalence of GCN + ranged from 6.9% to 88.9%, and the difference in ORR between patients with GCN + and those with non-increased  EGFR  GCN (GCN-) varied from −28% to 84%. Because of the significant heterogeneity, no quantitative synthesis of data was performed. There was a general trend towards higher ORR in patients with GCN+. The difference in ORRs between patients with GCN + and those with GCN- was even greater in  KRAS  wild-type patients, while in  KRAS  mutated patients the difference often did not exist. Almost all patients with  EGFR  amplification responded to the treatment. However, the prevalence of  EGFR  amplification was generally low. Incomplete data on progression-free survival and overall survival seemingly supported the findings on ORR.    Conclusions  Although increased  EGFR  GCN is generally associated with a better outcome of anti-EGFR MAbs treatment, especially among patients with wild-type  KRAS , the clinical utility of this biomarker for selecting recipients of anti-EGFR MAbs would be severely limited by the heterogeneous scoring system and the poor reproducibility of  EGFR  GCN enumeration due to technical reasons.

journal of hematology and oncology

EGFR gene copy number as a predictive biomarker for the treatment of metastatic colorectal cancer with anti-EGFR monoclonal antibodies: a meta-analysis