Efficacy of aflibercept with FOLFOX and maintenance with fluoropyrimidine as first‑line therapy for metastatic colorectal cancer: GERCOR VELVET phase II study.

摘要: Aflibercept in combination with 5‑fluorouracil (5‑FU)/irinotecan improves overall survival the second‑line therapy of patients metastatic colorectal cancer (mCRC). In this study, we evaluated effects aflibercept first‑line FOLFOX followed by maintenance fluoropyrimidine. VELVET was a prospective, single‑arm multicenter phase II study (completed). Patients previously untreated, unresectable, evaluable or measurable mCRC, an age ≥18 years, and ECOG performance status 0‑2 received 6 cycles modified FOLFOX7 (5‑FU/folinic acid oxaliplatin) at 4 mg/kg every 2 weeks fluoropyrimidine until disease progression limiting toxicity. The reintroduction oxaliplatin performed first progression. primary endpoint progression‑free (PFS) months. From May, 2013 to 2014, 49 were included 48 for response. total, 33 (67.4%) alive without Kaplan‑Meier 6‑month 1‑year PFS rates 79.1 36.1%, respectively, median 9.3 months (95% CI, 8.3‑12.5). objective response rate 59.2% (N=29/49). most common (≥10%) grade 3‑4 adverse events hypertension (23%), fatigue (15%), neutropenia (12%), neuropathy (12%) stomatitis (10%). Three (6%) treatment‑related deaths occurred: One from stroke, one pulmonary embolism neutropenic sepsis. On whole, demonstrates efficacy oxaliplatin‑based regimen mCRC. A strict monitoring blood pressure immediate management during is mandatory.