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Cediranib with mFOLFOX6 vs bevacizumab with mFOLFOX6 in previously treated metastatic colorectal cancer

机译:Cediranib联合mFOLFOX6与贝伐单抗联合mFOLFOX6在先前治疗的转移性大肠癌中

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摘要

Background:Cediranib is a highly potent inhibitor of vascular endothelial growth factor (VEGF) signalling with activity against all three VEGF receptors. Bevacizumab is an anti-VEGF-A monoclonal antibody with clinical benefit in previously treated metastatic colorectal cancer (mCRC).Methods:Patients with mCRC who had progressed following first-line therapy were randomised 1 : 1 : 1 to modified (m)FOLFOX6 plus cediranib (20 or 30 mg day(-1)) or bevacizumab (10 mg kg(-1) every 2 weeks). The primary objective was to compare progression-free survival (PFS) between treatment arms.Results:A total of 210 patients were included in the intent-to-treat (ITT) analysis (cediranib 20 mg, n=71; cediranib 30 mg, n=73; bevacizumab, n=66). Median PFS in the cediranib 20 mg, cediranib 30 mg and bevacizumab groups was 5.8, 7.2 and 7.8 months, respectively. There were no statistically significant differences between treatment arms for PFS (cediranib 20 mg vs bevacizumab: HR=1.28 (95% CI, 0.85-1.95; P=0.29); cediranib 30 mg vs bevacizumab: HR=1.17 (95% CI, 0.77-1.76; P=0.79)) or overall survival (OS). Grade 3 adverse events were more common with cediranib 30 mg (91.8%) vs cediranib 20 mg (81.4%) or bevacizumab (84.8%).Conclusion:There were no statistically significant differences between treatment arms for PFS or OS. When combined with mFOLFOX6, the 20 mg day(-1) dose of cediranib was better tolerated than the 30 mg day(-1) dose.
机译:背景:塞地尼布是一种高效的血管内皮生长因子(VEGF)信号抑制剂,对所有三种VEGF受体均具有活性。贝伐单抗是一种抗VEGF-A单克隆抗体,在先前治疗的转移性结直肠癌(mCRC)中具有临床意义。方法:将一线治疗后进展的mCRC患者随机分为1:1:1至改良(m)FOLFOX6 plus西地尼布(20或30mg / kg·day(-1))或贝伐单抗(每2周10mg / kg·kg(-1))。主要目的是比较治疗组之间的无进展生存期(PFS)。结果:意向性治疗(ITT)分析共纳入210例患者(西地尼布20毫克,n = 71;西地尼布30毫克, n = 73;贝伐单抗,n = 66)。西地尼20mg,西地尼30mg和贝伐单抗组的中位PFS分别为5.8、7.2和7.8个月。 PFS的治疗组之间差异无统计学意义(西地尼单抗20μmgvs贝伐单抗:HR = 1.28(95%CI,0.85-1.95; P = 0.29);西地尼单抗30μmgvs贝伐单抗:HR = 1.17(95%CI,0.77) -1.76; P = 0.79))或整体生存率(OS)。塞地尼布30 mg(91.8%)比塞地尼20 mg(81.4%)或贝伐单抗(84.8%)的3级不良事件更为常见。结论:PFS或OS的治疗组之间无统计学差异。当与mFOLFOX6联合使用时,西地尼布20μmg·day(-1)的剂量比30μmg·day(-1)的剂量具有更好的耐受性。

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