Epidermal growth factor receptor gene copy number in 101 advanced colorectal cancer patients treated with chemotherapy plus cetuximab | Campanella et al. Journal of Translational Medicine 2010 8 36 http content 8 1 36 JOURNAL OF TRANSLATIONAL MEDICINE RESEARCH Open Access Epidermal growth factor receptor gene copy number in 101 advanced colorectal cancer patients treated with chemotherapy plus cetuximab Carla Campanella 1 Marcella Mottolese42 Anna Cianciulli3 Angela Torsello1 Roberta Merola3 Isabella Sperduti4 Elisa Melucci2 Salvatore Conti2 Maria Grazia Diodoro2 Massimo Zeuli1 Giancarlo Paoletti5 Francesco Cognetti1 and Carlo Garufi 1 Abstract Background Responsiveness to Cetuximab alone can be mediated by an increase of Epidermal Growth factor Receptor EGFR Gene Copy Number GCN . Aim of this study was to assess the role of EGFR-GCN in advanced colorectal cancer CRC patients receiving chemotherapy plus Cetuximab. Methods One hundred and one advanced CRC patients 43 untreated- and 58 pre-treated were retrospectively studied by fluorescence in situ hybridization FISH to assess EGFR-GCN and by immunohistochemistry IHC to determine EGFR expression. Sixty-one out of 101 patients were evaluated also for k-ras status by direct sequencing. Clinical end-points were response rate RR progression-free survival PFS and overall survival OS . Results Increased EGFR-GCN was found in 60 101 59 tumor samples. There was no correlation between intensity of EGFR-IHC and EGFR-GCN p . Patients receiving chemotherapy plus Cetuximab as first line treatment had a RR of 70 30 43 while it was 18 10 56 in the group with previous lines of therapy p . RR was observed in 29 60 48 of patients with increased EGFR-GCN and in 6 28 21 in those without p . At multivariate analyses number of chemotherapy lines and increased EGFR-GCN were predictive of response EGFR-IHC score increased EGFR-GCN and number of chemotherapy lines were significantly associated with a significant better PFS. Response to therapy was the only prognostic predictive factor for OS. In the 60 patients analyzed for .