Designing Therapeutic Trial in Metastatic Gastric Cancer in 2014

Abstract

Despite the advent of trastuzumab for HER2 positive and ramucirumab as second line therapy in platinium/fluoropyrimidine pre-treated advanced gastric cancer patients, there is still a high level of unmet needs in view of the poor prognosis. Until recently, almost all biological agents in phase III testing in patients with advanced gastric cancer are already licensed in other solid tumours, nowadays many new agents are being evaluated first in advanced gastric cancer. Whereas predictive biomarkers might already be established for agents used in other solid tumours, the newer agents would require parallel development of predictive biomarkers. Thus designing advanced gastric cancer trials present a number of challenges: 1) geographical variation with either underlying tumour biology or treatment practice; 2) optimum chemotherapy backbone if used in combination; 3) effective second and subsequent line treatment might dilute any overall survival benefit; 4) evaluation and validation of predictive biomaker and whether data on other solid tumours are transferable to advanced gastric cancer and 5) embedment of quality of life and cost-effectiveness assessment in late phase studies.