BACKGROUND: Clinical data showed promising antitumour activity with feasible 
tolerability for matuzumab plus epirubicin, cisplatin and capecitabine (ECX) 
chemotherapy in untreated advanced oesophago-gastric (OG) cancer. The aim was to 
evaluate the efficacy of matuzumab plus ECX versus ECX alone.
PATIENTS AND METHODS: In this multicentre, randomised open-label phase II study, 
72 patients with metastatic OG cancer were randomly assigned to either 800 mg 
matuzumab weekly plus epirubicin 50 mg/m², cisplatin 60 mg/m² on day 1 and 
capecitabine 1250 mg/m² daily in a 21-day cycle (ECX) or the same ECX regimen 
alone. The primary end point was objective response. Secondary end points 
included progression-free survival (PFS), overall survival (OS), quality of 
life, safety and tolerability.
RESULTS: Following random assignment, 35 patients (median age 59 years) received 
ECX/matuzumab and 36 patients (median age 64 years) ECX. The addition of 
matuzumab to ECX did not improve objective response: 31% for ECX/matuzumab [95% 
confidence interval (CI) 17-49] compared with 58% for the ECX arm (95% CI 41-74) 
P = 0.994 (one sided). There was no significant difference in median PFS: 4.8 
months (95% CI 2.9-8.1) for ECX/matuzumab versus 7.1 months (95% CI 4.4-8.5) for 
ECX, or in median OS: 9.4 months (95% CI 7.5-16.2), compared with 12.2 months 
(95% CI 9.8-13.8 months). Grade 3/4 treatment-related toxicity was observed in 
27 and 25 patients in the ECX/matuzumab and ECX groups, respectively.
CONCLUSION: Matuzumab 800 mg weekly combined with ECX chemotherapy does not 
increase response or survival for patients with advanced OG cancer. Therefore, 
ECX/matuzumab should not be examined further in phase III trials.