The value of additional bevacizumab in patients with high-risk stroma-high colon cancer. A study within the QUASAR2 trial, an open-label randomized phase 3 trial.

INTRODUCTION: Patients with a high stroma percentage within the primary tumor have a poor prognosis. In this study, we investigate whether anti-angiogenic therapy might improve survival of patients with a stroma-high profile with potentially increased angiogenesis. MATERIALS AND METHODS: Tissue samples of the primary tumor of 965 colon cancer patients participating in the QUASAR2 trial were analyzed for tumor-stroma ratio (TSR). Stroma-high (>50%) and stroma-low (≤50%) groups were evaluated with respect to survival. RESULTS: Disease free survival (DFS) was significantly lower in the stroma-high group (HR 1.53, 95%CI 1.19-1.95, P = 0.001). No difference in DFS was seen with respect to treatment with capecitabine alone (CAP) or capecitabine with bevacizumab (CAPBEV) (Stroma-high HR 1.00, 95%CI 0.69-1.46, P = 0.996; stroma-low HR 1.02, 95%CI 0.75-1.41, P = 0.883). A significant difference in survival was seen comparing groups with or without vascular invasion (DFS P