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
{"title":"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","authors":"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","doi":"10.17650/2686-9594-2021-11-3-4-11-17","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":34449,"journal":{"name":"Tazovaia khirurgiia i onkologiia","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and toxicity of aflibercept and bevacizumab in combination with FOLFIRI in second‑line therapy for metastatic colon cancer: a retrospective multicenter study\",\"authors\":\"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\",\"doi\":\"10.17650/2686-9594-2021-11-3-4-11-17\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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.\",\"PeriodicalId\":34449,\"journal\":{\"name\":\"Tazovaia khirurgiia i onkologiia\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-03-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Tazovaia khirurgiia i onkologiia\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.17650/2686-9594-2021-11-3-4-11-17\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Tazovaia khirurgiia i onkologiia","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17650/2686-9594-2021-11-3-4-11-17","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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。
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.