Association Between Immune-Related Adverse Events and Clinical Efficacy in Patients with Melanoma Treated With Nivolumab: A Multicenter Retrospective Study
Association Between Immune-Related Adverse Events and Clinical Efficacy in Patients with Melanoma Treated With Nivolumab: A Multicenter Retrospective Study
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DOI：
10.1016/j.clinthera.2018.11.004
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发表时间：
2019-01-01
影响因子：
3.2
通讯作者：
Ishizawa, Keisuke
中科院分区：
文献类型：
--
作者：
Okada, Naoto;Kawazoe, Hitoshi;Ishizawa, Keisuke
目的：Nivolumab是一种抗程序性死亡1抗体，通过激活宿主免疫产生抗肿瘤作用，但也会引起免疫相关不良事件（irAEs）。本研究的目的是分析尼武单抗在黑色素瘤患者中抗肿瘤效果与诱导的irAEs之间的关系。方法：选取2015年1月至2016年12月期间在德岛大学医院或爱媛大学医院接受nivolumab治疗的15例黑色素瘤患者。在纳武单抗治疗期间发生和未发生irAEs的患者分别被分为irAEs阳性组（n = 8）和irAEs阴性组（n = 7）。比较两组患者的疾病控制率（DCR）和总生存期（OS）。他们还分析了血细胞计数的数据。结果：纳武单抗治疗中位数为4个周期后，发生了irae。iraes阳性组dcr为75%，阴性组dcr为14% （p < 0.05）。iraes阳性组的OS高于iraes阴性组（p < 0.05）。多变量Cox比例风险回归分析显示，irAE的发生影响纳武单抗治疗的OS。此外，在nivolumab治疗4个周期后，irAEs阳性组irAEs发病时基线外周血淋巴细胞计数的增加明显大于irAEs阴性组（p < 0.05）。(C) 2018爱思唯尔公司版权所有。
Purpose: Nivolumab, an anti-programmed death 1 antibody, produces antitumor effects by activating host immunity, which also causes immune-related adverse events (irAEs). The aim of this study was to analyze the association between antitumor effect and irAEs induced by nivolumab in patients with melanoma.Methods: Fifteen patients with melanoma who had received nivolumab at Tokushima University Hospital or Ehime University Hospital between January 2015 and December 2016 were enrolled in this study. Patients who had and did not have irAEs during nivolumab treatment were classified into an irAEs-positive group (n = 8) and an irAEs-negative group (n = 7), respectively. We compared the disease control rate (DCR) and overall survival (OS) between the 2 groups. Data on blood cell counts were also analyzed.Findings: After a median of 4 cycles of nivolumab treatment, irAEs occurred. The DCRs were 75% and 14% in the irAEs-positive and irAEs-negative groups, respectively (p < 0.05). OS in the irAEs-positive group was higher than that in the irAEs-negative group (p < 0.05). Multivariable Cox proportional hazards regression analysis revealed that irAE occurrence affected OS with nivolumab treatment. Moreover, the increase in baseline peripheral lymphocyte count at the time of onset of irAEs was significantly greater in the irAEs-positive group than in the irAEs-negative group after 4 cycles of nivolumab treatment (p < 0.05). (C) 2018 Elsevier Inc. All rights reserved.