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纳武单抗/欧狄沃 Nivolumab(Opdivo)联合伊匹单抗(YERVOY)治疗晚期非小细胞肺癌

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    印度代购提示您,简介:由美国纪念斯隆-凯特琳癌症中心开展的一项随机对照III期研究(checkmate227)结果近日在《新英格兰医学》杂志(IF=70.67)发表。本研究的主要目的是评估纳武利尤单抗或者纳武利尤单抗为基础的联合方案一线治疗晚期非小细胞肺癌的疗效,结果表明与单纯化疗组相比,纳武利尤单抗联合伊匹单抗组一线治疗非小细胞肺癌有更长的生存获益。  研究背景:在早前的关于治疗晚期非小细胞肺癌患者的研究中,纳武利尤单抗联合伊匹单抗组治疗晚期非小细胞肺癌有效率高于纳武利尤单抗单药组,特别是在肿瘤组织中表达程序性死亡配体1 (PD-L1)的患者效果更明显。但是需要纳武利尤单抗联合伊匹单抗组治疗晚期非小细胞肺癌患的长期获益的数据进行进一步的评估验证。  

Results of a randomized controlled phase III study (checkmate227) conducted by memorial sloan-kettering cancer center (memorial sloan-kettering cancer center, USA) were recently published in the New England journal of medicine (IF=70.67). The primary objective of this study was to evaluate the efficacy of either a combination of navurliumab or a combination of navurliumab and ipilimumab in first-line treatment of advanced NSCLC. Results showed that navurliumab and ipilimumab had a longer survival benefit in first-line treatment of NSCLC compared with chemotherapy alone. Background: In an earlier study of patients with advanced NSCLC, the efficacy of navurliumab combined with ipilimumab was higher than that of navurliumab alone, especially in patients expressing programmed death ligand 1 (PD-L1) in tumor tissue. However, data on the long-term benefit of the combination of nafulizumab and ipilimumab in patients with advanced NSCLC are needed for further evaluation.

 

  印度代购提示您,研究方法:在这项开放的III期研究中,随机把PD-L1表达大于等于1%的晚期或复发的非小细胞肺癌患者按照1:1:1的比例分配到纳武利尤单抗联合伊匹单抗组、纳武利尤单抗单药组、单纯化疗组。把PD-L1小于1%的患者按照1:1:1的比例随机分配到纳武利尤单抗联合伊匹单抗组、纳武利尤单抗联合化疗组、单纯化疗组。所有患者接受治疗前均未接受过化疗,主要研究终点为在PD-L1表达大于等于1%的晚期或复发的非小细胞肺癌患者中纳武利尤单抗联合伊匹单抗组与单纯化疗组总生存比较。

  

  印度代购提示您,研究结果:在PD-L1表达大于等于1%的晚期或复发的非小细胞肺癌患者中纳武利尤单抗联合伊匹单抗组和单纯化疗组的中位总生存时间分别为17.1个月(95% CI,15.0-20.1)14.9个月(95% CI,12.7-16.7)(P=0.007)2年生存率分别为40%32.8%。纳武利尤单抗联合伊匹单抗组和单纯化疗组的中位有效时间分别为23.2个月和6.2个月。在PD-L1表达小于1%的晚期或复发的非小细胞肺癌患者中也观察到生存获益,纳武利尤单抗联合伊匹单抗组和单纯化疗组的中位总生存时间分别为17.2个月(95% CI,12.8-22.0)和12.2个月(95% CI,9.2-14.3)。在所有的研究患者中纳武利尤单抗联合伊匹单抗组和单纯化疗组的中位总生存时间分别为17.1个月(95% CI,15.2-19.9)和13.9个月(95% CI,12.2-15.1),纳武利尤单抗联合伊匹单抗组和单纯化疗组的3/4度不良反应发生率分别为32.8%36%

  

  印度代购提示您,研究结论:无论PD-L1表达水平,与单纯化疗组相比纳武利尤单抗联合伊匹单抗组一线治疗非小细胞肺癌有更长的生存获益。

Conclusion: Regardless of pD-L1 expression level, the first-line treatment of NSCLC with navurliumab combined with ipilimumab had a longer survival benefit compared with chemotherapy alone.


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