催眠药
医学
结直肠癌
安慰剂
血管内皮生长因子
血管内皮生长因子受体
贝伐单抗
肿瘤科
内科学
癌症
生物标志物
福尔菲里
胃肠病学
化疗
病理
奥沙利铂
化学
替代医学
生物化学
作者
Hiroya Taniguchi,Takayuki Yoshino,Kensei Yamaguchi,Kentaro Yamazaki,Andrew B. Nixon,Josep Tabernero,Éric Van Cutsem,Kim Robling,Paolo Abada,Rebecca R. Hozak,Robert W. Siegel,Jeffrey Fill,Sameera R. Wijayawardana,Richard A. Walgren,Brendan M. Giles,Abby Jones,Kelly R. Pitts,Nora Drove,Kei Muro
标识
DOI:10.1080/03007995.2021.1940908
摘要
Background Vascular endothelial growth factor (VEGF)-D was identified as a potential predictive biomarker for ramucirumab efficacy in second-line metastatic colorectal cancer using a research use only (RUO) assay. We describe results with a new assay for detecting VEGF-D in human plasma.Methods In RAISE (Clinical Trial Registration: NCT01183780), 1072 patients were randomized 1:1 to ramucirumab or placebo plus FOLFIRI. All patients were then randomized 1:2 to marker exploratory (ME) and marker confirmatory (MC) groups, and those with plasma samples were analyzed accordingly. A new assay validated for investigational use only (IUO) was used to measure VEGF-D levels in plasma, which were analyzed for correlation with overall and progression-free survival (OS/PFS). IUO assay data were compared with historical RUO assay data.Results ME subset analyses determined the optimal cutpoint of 5.4 ng/mL for defining high/low VEGF-D subgroups. In the combined ME/MC placebo arms, OS/PFS were numerically greater for patients with low vs high VEGF-D (OS: 12.8 vs 11.1 months; PFS: 5.6 vs 4.2 months). In patients with high VEGF-D, ramucirumab vs placebo demonstrated a numerically greater improvement in OS and PFS. Differential efficacy by VEGF-D level was statistically significant for PFS, but not OS.Conclusion In patients with high VEGF-D, ramucirumab demonstrated a greater improvement in OS and PFS vs placebo; however, baseline VEGF-D level was not predictive of ramucirumab OS benefit using VEGF-D assay for IUO. The RAISE intent-to-treat results remain valid.
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