Durvalumab therapy following chemoradiation compared with a historical cohort treated with chemoradiation alone in patients with stage III non-small cell lung cancer: A real-world multicentre study

Durvalumab therapy following chemoradiation compared with a historical cohort treated with chemoradiation alone in patients with stage III non-small cell lung cancer: A real-world multicentre study
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DOI:
10.1016/j.ejca.2020.10.008
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发表时间:
2021-01-01
影响因子:
8.4
通讯作者:
Elkrief, Arielle
Elkrief, Arielle
中科院分区:
医学1区
文献类型:
--
作者:
Desilets, Antoine;Blanc-Durand, Felix;Elkrief, Arielle

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背景:太平洋试验表明,化疗后放疗(CRT)后的Durvalumab治疗与改善III期非小细胞肺癌(NSCLC)患者的总生存率(OS)有关。目前尚不清楚作为随机对照试验一部分获得的结果是否反映了真实世界(RW)的数据。关于RW Durvalumab的使用,仍有几个问题没有得到回答,例如开始Durvalumab的最佳时间、肺炎的发生率以及PD-L1亚组的反应。方法:在这项多中心回顾分析中,147例III期NSCLC患者在接受CRT治疗后再接受Durvalumab治疗,并与121例单独接受CRT治疗的历史队列患者进行比较。生存曲线的估计采用Kaplan-Meier方法,并与单因素分析中的对数等级检验进行比较。多因素分析评估标准预后因素对杜伐单抗使用的影响。结果:杜伐单抗组未达到中位OS,而历史组为26.9月(危险比[HR]:0.56,95%可信区间[CI]:0.37e0.85,p=0.001)。在杜伐单抗组,我们的数据表明PD-L1表达和Gt;=50%的患者12个月的OS有所改善(100%对86%,HR:0.25,95%CI:0.11-0.58,p Z 0.007)。PD-L1表达在1-49%的患者与PD-L1表达为50%的患者之间的OS没有差异,在接受CRT后接受Durvalumab治疗的III期NSCLC患者中,OS与良好的OS相关,而肺炎的存在则是一个负面的预后因素。(C)2020爱思唯尔有限公司。保留所有权利。
Background: The PACIFIC trial demonstrated that durvalumab therapy following chemoradiation (CRT) was associated with improved overall survival (OS) in patients with stage III nonesmall cell lung cancer (NSCLC). It is unclear whether the results obtained as part of randomised controlled trials are a reflection of real-world (RW) data. Several questions remain unanswered with regard to RW durvalumab use, such as optimal time to durvalumab initiation, incidence of pneumonitis and response in PD-L1 subgroups.Methods: In this multicentre retrospective analysis, 147 patients with stage III NSCLC treated with CRT followed by durvalumab were compared with a historical cohort of 121 patients treated with CRT alone. Survival curves were estimated using the Kaplan-Meier method and compared with the log-rank test in univariate analysis. Multivariate analysis was performed to evaluate the effect of standard prognostic factors for durvalumab use.Results: Median OS was not reached in the durvalumab group, compared with 26.9 months in the historical group (hazard ratio [HR]: 0.56, 95% confidence interval [CI]: 0.37e0.85, p = 0.001). In the durvalumab group, our data suggest improved 12-month OS in patients with PD-L1 expression >= 50% (100% vs 86%, HR: 0.25, 95% CI: 0.11-0.58, p Z 0.007). There was no difference in OS between patients with a PD-L1 expression of 1-49% and patients with PD-L1 expression = 50% was associated with favourable OS in patients with stage III NSCLC treated with durvalumab after CRT, whereas the presence of pneumonitis represented a negative prognostic factor. (C) 2020 Elsevier Ltd. All rights reserved.