阿非利西普和贝伐单抗联合FOLFIRI二线治疗转移性结肠癌的疗效和毒性:一项回顾性多中心研究

M. Fedyanin, L. Vladimirova, V. Chubenko, L. Zagorskaya, A. Belyaeva, O. L. Fakhrutdinova, S. Belukhin, A. Zhabina, L. Khalikova, L. Bolotina, R. Orlova, F. Moiseenko, G. Mukhametshina, A. Khasanova, A. Belonogov, Kh.Sa. Musaeva, O. Novikova, I. Stradaeva, I. Popova, S. Erdniev, A. Ivanova, A. Androsova, P. Feoktistova, E. Kuzmina, E. Karabina, O. V. Nekrasova, O. Sekhina, Ales Mishchenko, L. A. Mukova, B. Kertiev, G. I. Kosar, S. N. Osodoeva, A. I. Kats, R. Malina, M. Lyadova, A. Tryakin, S. Tyulandin
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引用次数: 0

摘要

目的:比较阿非利西普与贝伐单抗联合fOLfIRI二线治疗转移性结肠癌患者的疗效和毒性。材料和方法。我们对俄罗斯联邦9家诊所治疗的转移性结肠癌患者的数据进行了回顾性分析。纳入标准如下:转移性或局部晚期结肠癌;在二线治疗中使用贝伐单抗或阿非利塞普加fOLfIRI。主要结局指标为无进展生存期(PfS)。次要结局指标包括客观有效率和不良事件发生率。在2014年至2018年期间,共有271例接受贝伐单抗(n = 81)或阿非利塞普(n = 190)二线治疗的转移性结肠癌患者被纳入本研究。各研究组对主要预后体征进行匹配。贝伐单抗组客观有效率为18.1%,阿非利西普组为20.5% (p = 0.7)。阿非利西普组的中位PfS为5个月(95%可信区间3.8-6.1),贝伐单抗组的中位PfS为7个月(95%可信区间0.81-2.1)(风险比1.4;95%置信区间0.99-2.1;P = 0.04)。多因素回归分析显示,单独的靶向药物类型对PfS没有影响(风险比为1.3;95%置信区间0.9-1.9;P = 0.2)。我们观察到两组间任何级别并发症的发生率无统计学差异(58% vs 72%, p = 0.1)。接受阿非利西普治疗的患者更容易发生III-Iv级动脉高血压(2%对9.5%)和腹泻(0%对5.4%),而贝伐单抗组血栓并发症更常见(10%对1.8%)。我们观察到转移性结肠癌患者接受贝伐单抗或阿非利塞普联合fOLfIRI作为二线治疗的客观缓解率和PfS无显著差异。毒性谱是不同的。我们的发现可以用于选择最佳的靶向药物进行二线治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and toxicity of aflibercept and bevacizumab in combination with FOLFIRI in second‑line therapy for metastatic colon cancer: a retrospective multicenter study
Objective: to compare the efficacy and toxicity of aflibercept and bevacizumab in combination with fOLfIRI in secondline therapy for patients with metastatic colon cancer.Materials and methods. we performed a retrospective analysis of data on patients with metastatic colon cancer treated in 9 clinics in the Russian federation. The inclusion criteria were as follows: metastatic or locally advanced colon cancer; treatment with bevacizumab or aflibercept plus fOLfIRI in the second-line therapy. The primary outcome measure was progression-free survival (PfS). Secondary outcome measures included objective response rate and incidence of adverse events.Results. A total of 271 patients with metastatic colon cancer who received second-line therapy with bevacizumab (n = 81) or aflibercept (n = 190) between 2014 and 2018 were selected for this study. Study groups were matched for main prognostic signs. The objective response rate was 18.1 % in the bevacizumab group and 20.5 % in the aflibercept group (p = 0.7). The median PfS was 5 months (95 % confidence interval 3.8–6.1) in the aflibercept group and 7 months (95 % confidence interval 0.81–2.1) in the bevacizumab group (hazard ratio 1.4; 95 % confidence interval 0.99–2.1; p = 0.04). multivariate regression analysis demonstrated that the type of the targeted drug independently had no effect on PfS (hazard ratio 1.3; 95 % confidence interval 0.9–1.9; p = 0.2). we observed no statistically significant differences in the incidence of complications of any grades between the groups (58 % vs 72 %, p = 0.1). Patients receiving aflibercept were more likely to develop grade III–Iv arterial hypertension (2 % vs 9.5 %) and diarrhea (0 % vs 5.4 %), whereas thrombotic complications were more common in the bevacizumab group (10 % vs 1.8 %).Conclusion. we observed no significant differences in objective response rate and PfS between patients with metastatic colon cancer receiving bevacizumab or aflibercept in combination with fOLfIRI as second-line therapy. The toxicity profiles were different. Our findings can be used for choosing an optimal targeted drug for second-line treatment.
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