O-0024 Phase 2 Randomized, Noncomparative, Open-Label Study of Aflibercept and Modified Folfox6 in the First-Line Treatment of Metastatic Colorectal Cancer (AFFIRM)

摘要: ABSTRACT Introduction Aflibercept is a recombinant human fusion protein that acts as decoy receptor preventing VEGF-A, VEGF-B, and PlGF from interacting with their receptors. The phase 3 VELOUR study demonstrated statistically significant survival benefit the combination of aflibercept + FOLFIRI in metastatic colorectal cancer (mCRC) patients who had progressed during or after prior oxaliplatin-based chemotherapy. Modified (m) FOLFOX6 an established first-line regimen for mCRC. Preclinical clinical evidence supported evaluation mFOLFOX6 treatment An arm was included calibrator; not powered statistical comparison. Methods primary endpoint progression-free rate at 12 months (PFS12). A secondary objective to explore biomarkers. Patients previously untreated mCRC, ECOG PS 0-2, adequate organ function were randomized 1:1 receive 4 mg/kg (A) (B), every 2 weeks, stratified by (0-1/2), adjuvant therapy (yes/no), metastases confined liver (yes/no). be treated disease progression. PFS12 response assessed according RECIST criteria Independent Review Committee blinded allocation. Results From March 2009 April 2010, 236 (median age, 62.5 years; male, 61% 0-1, 97.5% therapy, 10.2% only, 28.4%) (n = 119) B 117). Baseline characteristics similar both arms. 25.8% (95% CI: 17.2-34.4) 21.2% 12.2-30.3) B. Response 49.1% 39.7-58.6) 45.9% 36.4-55.7) B, median PFS 8.48 7.89-9.92) 8.77 7.62-9.27) Overall data limited maturity, less than 43% death events each arm. Grade 3-4 adverse >5% higher incidence relative hypertension, proteinuria, neutropenia, diarrhea, infections. Biomarker will presented meeting. Conclusion In this study, appeared mFOLFOX6, although biomarker analyses interpretation safety profile consistent seen studies.