Human equilibrative nucleoside transporter 1 is not predictive for gemcitabine efficacy in advanced pancreatic cancer: Translational results from the AIO-PK0104 phase III study with the clone SP120 rabbit antibody

摘要: Abstract Background The role of human equilibrative nucleoside transporter 1 (hENT1) as a predictive biomarker for gemcitabine efficacy in advanced pancreatic cancer remains unclear to date. Patients and methods AIO-PK0104 was German multicenter phase III trial comparing gemcitabine/erlotinib followed by capecitabine (GEC) with capecitabine/erlotinib (CEG) cancer. Archival tumour tissue from 169 the 274 eligible study patients available central standardised immunohistochemistry staining hENT1 expression using SP120 rabbit monoclonal anti-hENT1 antibody. Within retrospective translational subgroup analysis, data were correlated end-points. Results Thirty-nine out 130 fresh-cut slides scored high (30%), whereas 91 samples classified low (70%). For 62 randomised CEG median overall survival estimated 6.4months compared 6.9months (Hazard Ratio (HR) 0.88, 95% confidence interval (CI) 0.48–1.61, p =0.67). 68 GEC 5.7months 4.4months (HR 1.16, CI 0.69–1.96, =0.57). In 101 receiving at any time during treatment (either within 1st- or 2nd-line setting) cases had 7.5months an 1.30, 0.84–2.03, =0.24), respectively. Conclusion this analysis Arbeitsgemeinschaft Internistische Onkologie-pancreatic (AIO-PK0104), no evidence supporting use found.