A Randomised Multicentre Trial of Epirubicin, Oxaliplatin and Capecitabine (EOC) + Panitumumab in advanced Oesophago-Gastric Cancer (REAL3): Updated Results

ABSTRACT Background EGFR overexpression occurs in 30-90% of oesophago-gastric adenocarcinomas (OGA), and correlates with poor prognosis. The REAL-3 trial evaluated the addition of the anti-EGFR antibody panitumumab (P) to epirubicin, oxaliplatin and capecitabine (EOC) in advanced OGA. Methods Patients with untreated, metastatic or locally advanced OGA were randomised to EOC (E 50mg/m2, O 130mg/m2, C 1250mg/m2/day) or mEOC + P (E 50mg/m2, O 100mg/m2, C 1000mg/m2/day, P 9mg/kg). Primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS), response rate (RR), toxicity, and biomarker evaluation. Response was evaluated by RECIST after 4 and 8 cycles. Results 553 patients were recruited (EOC 275, mEOC + P 278). Median OS was 11.3 months with EOC compared to 8.8 months with mEOC + P (HR 1.37: 95% CI 1.07-1.76, p = 0.013). Median PFS was 7.4 and 6.0 months respectively (HR 1.22: 95% CI 0.98-1.52, p = 0.068), with RR being 42% compared to 46% (odds ratio 1.16: 95% CI 0.81-1.57, p = 0.467). In the mEOC + P arm, OS was significantly improved in patients with G1-3 rash (77%, n = 209) on treatment compared to those without (23%, n = 63); median OS 10.2 vs 4.3 months (p  Disclosure I. Chau: I have a compensated advisory role with Roche. I have also received honoraria and research funding from Roche. D. Cunningham: I have received research funding from Amgen, Roche, Merck-Serono. I have undertaken uncompensated advisory roles for Amgen and Roche. I have provided an uncompensated expert testimony for Amgen. All other authors have declared no conflicts of interest.