ABSTRACT
Aflibercept in combination with 5fluorouracil (5FU)/irinotecan improves overall survival in the secondline therapy of patients with metastatic colorectal cancer (mCRC). In this study, we evaluated the effects of aflibercept in firstline therapy with FOLFOX followed by maintenance with fluoropyrimidine. VELVET was a prospective, singlearm multicenter phase II study (completed). Patients with previously untreated, unresectable, evaluable or measurable mCRC, with an age ≥18 years, and an ECOG performance status of 02 received 6 cycles of modified FOLFOX7 (5FU/folinic acid and oxaliplatin) with aflibercept at 4 mg/kg every 2 weeks followed by maintenance therapy with fluoropyrimidine with aflibercept until disease progression or limiting toxicity. The reintroduction of oxaliplatin was performed at first progression. The primary endpoint was progressionfree survival (PFS) at 6 months. From May, 2013 to May, 2014, 49 patients were included and 48 were evaluable for response. In total, 33 patients (67.4%) were alive without progression at 6 months. The KaplanMeier survival 6month and 1year PFS rates were 79.1 and 36.1%, respectively, and the median PFS was 9.3 months (95% CI, 8.312.5). The objective response rate was 59.2% (N=29/49). The most common (≥10%) grade 34 adverse events were hypertension (23%), fatigue (15%), neutropenia (12%), neuropathy (12%) and stomatitis (10%). Three (6%) treatmentrelated deaths occurred: One from stroke, one from pulmonary embolism and one from neutropenic sepsis. On the whole, this study demonstrates the efficacy of aflibercept in combination with an oxaliplatinbased regimen in the firstline therapy of patients with mCRC. A strict monitoring of blood pressure and immediate management of hypertension during therapy is mandatory.