Multicenter double-blind randomized phase II: FOLFOX + ziv-aflibercept/placebo for patients (pts) with chemo-naive metastatic esophagogastric adenocarcinoma (MEGA)

4 Background: FOLFOX has RR 53% and PFS 6.8 months in MEGA (CALGB 80403). VEGF inhibition has improved survival in some but not all randomized trials in MEGA. Ziv-aflibercept binds VEGF-A, B and PlGF and has improved survival in refractory metastatic colorectal cancer. Methods: All pts received mFOLFOX6 q14d. Pts were randomized 2:1 to A) ziv-aflibercept 4mg/kg/d1 or B) placebo. Pts were restaged every 8wks. Primary endpoint: 6mos PFS. Results: 64 pts enrolled (Jan 2013-Apr 2015): sex: 55M/9F; age (median): 32-83 (62); ECOG PS 0/1/2: 33/28/3; primary tumor: esophagus 26/GEJ 18/gastric 20; measurable/evaluable: 52/12; metastases: LN 48/liver 25/lung 15, other 12/adrenal 4/bone 3. Of 64 pts: 34 POD, 9 off for tox, 4 died on tx, 3 withdrew, 4 other, 10 on tx (see Table). Conclusion: Ziv-aflibercept did not significantly improve the efficacy of FOLFOX. HTN was predictive of response to ziv-aflibercept. Except for HTN, there was no significant difference in toxicity between tx arms. Clinical trial information: NCT01747551. [Table: see text]