Phase II trial of aflibercept (VEGF Trap) in previously treated patients with metastatic colorectal cancer (MCRC): A PMH phase II consortium trial

4027 Background: Vascular endothelial growth factor (VEGF) is an important target in MCRC. Aflibercept (VEGF Trap) is a recombinant fusion protein of the human VEGFR1 and R2 extracellular domains and the Fc portion of human IgG1. Methods: This is an open-label, multi-centre, 2-stage phase II trial in pts with MCRC. Eligibility criteria: >1 prior systemic therapy for MCRC, ECOG < 2. Exclusion criteria: prior treatment with a VEGF or VEGFR inhibitor other than bevacizumab (BEV). IV VEGF Trap (4 mg/kg) was administered every 2 weeks (1 cycle). The primary endpoint was RR and 4-month PFS. Pts were enrolled in two cohorts: BEV naive and prior BEV. Planned sample size in each cohort was 40 pts. Results: In total, 51 pts were enrolled (BEV naive = 24 pts; prior BEV = 27; median age=59, range 39–80; M:F = 30:21; ECOG 0:1:2 = 21:27:3; median # prior regimens for MCRC = 2, range 1–6). After 287 cycles of therapy, most common treatment adverse events (TAEs) of any grade were (#pts): fatigue (40), hypertension (28), ...