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Immune-related adverse events correlate with clinical outcomes in NSCLC patients treated with nivolumab: The Italian NSCLC expanded access program.
Lung Cancer ( IF 4.5 ) Pub Date : 2019-12-20 , DOI: 10.1016/j.lungcan.2019.12.014
Editta Baldini 1 , Alice Lunghi 1 , Enrico Cortesi 2 , Daniele Turci 3 , Diego Signorelli 4 , Valeria Stati 5 , Barbara Melotti 6 , Biagio Ricciuti 7 , Antonio Frassoldati 8 , Giampiero Romano 9 , Giovanni Luca Ceresoli 10 , Alfonso Illiano 11 , Francesco Verderame 12 , Gianpiero Fasola 13 , Enrico Ricevuto 14 , Paolo Marchetti 15 , Carmine Pinto 16 , Giacomo Cartenì 17 , Vieri Scotti 18 , Carmelo Tibaldi 1 , Luisa Fioretto 19 , Diana Giannarelli 20
Affiliation  

OBJECTIVES The incidence of any and of severe-grade immune-related adverse events (irAEs) with second-line nivolumab monotherapy is 31-65 % and 2-5 % respectively. While potentially serious and even fatal, in the absence of an appropriate therapy, such events might be indicators of the activation of the immune system and, potentially, of efficacy. MATERIALS AND METHODS We collected the records of 1959 non-small-cell lung cancer (NSCLC) patients treated with nivolumab in the Italian expanded access program, and we registered the appearance of any and of severe grade irAEs. We retrospectively searched for correlations between toxicity and efficacy parameters by using Cox's regression analysis. RESULTS Overall, 342 (17.8%) patients developed an irAE of any grade. We observed that patients developing irAE of any grade achieved a significantly higher response rate (RR 27.2% vs 15.2%; p < 0.0001), disease control rate (DCR 60.5% vs 40.2%; p < 0.0001), median progression-free survival (mPFS 6.0 months [95% CI 4.9-7.1] vs 3.0 [95% CI: 2.8-3.2], p < 0.0001) and median overall survival (mOS 16.7 months [95% CI: 13.5-19.9] vs 9.4 [95% CI: 8.4-10.4], p < 0.00001) compared to patients who did not. At multivariate analysis the development of an irAE remained an independent indicator of nivolumab efficacy (HR 1.44 [95% CI: 1.22-1.71] p < 0.0001). CONCLUSIONS This report, performed in Caucasian NSCLC patients, showed that the appearance of irAEs correlated with outcome.

中文翻译:

免疫相关的不良事件与接受nivolumab治疗的NSCLC患者的临床结局相关:意大利NSCLC扩展访问计划。

目的二线纳武单抗单药治疗的任何和严重程度的免疫相关不良事件(irAEs)的发生率分别为31-65%和2-5%。尽管可能是严重的甚至是致命的,但在没有适当的治疗的情况下,此类事件可能是免疫系统激活以及可能的功效指标。材料和方法我们收集了1959年在意大利的扩展准入计划中接受nivolumab治疗的1959年非小细胞肺癌(NSCLC)患者的记录,并记录了任何严重重度irAE的出现。我们使用Cox回归分析回顾性研究了毒性和功效参数之间的相关性。结果总体上,有342名(17.8%)患者发生了任何级别的irAE。我们观察到,任何级别的irAE患者均获得了显着更高的缓解率(RR 27.2%vs 15.2%; p <0.0001),疾病控制率(DCR 60.5%vs 40.2%; p <0.0001),中位无进展生存期( mPFS 6.0个月[95%CI 4.9-7.1]与3.0 [95%CI:2.8-3.2],p <0.0001)和中位总体生存率(mOS 16.7个月[95%CI:13.5-19.9]与9.4 [95%CI :8.4-10.4],p <0.00001)。在多变量分析中,irAE的发生仍是尼古鲁单抗疗效的独立指标(HR 1.44 [95%CI:1.22-1.71] p <0.0001)。结论本报告在白种人NSCLC患者中进行,显示irAE的出现与预后相关。中位无进展生存期(mPFS 6.0个月[95%CI 4.9-7.1]与3.0 [95%CI:2.8-3.2],p <0.0001)和中位总体生存期(mOS 16.7个月[95%CI:13.5-19.9]与9.4 [95%CI:8.4-10.4],p <0.00001)进行比较。在多变量分析中,irAE的发生仍是尼古鲁单抗疗效的独立指标(HR 1.44 [95%CI:1.22-1.71] p <0.0001)。结论本报告在白种人NSCLC患者中进行,显示irAEs的出现与预后相关。中位无进展生存期(mPFS 6.0个月[95%CI 4.9-7.1]与3.0 [95%CI:2.8-3.2],p <0.0001)和中位总体生存期(mOS 16.7个月[95%CI:13.5-19.9]与9.4 [95%CI:8.4-10.4],p <0.00001)进行比较。在多变量分析中,irAE的发生仍是尼古鲁单抗疗效的独立指标(HR 1.44 [95%CI:1.22-1.71] p <0.0001)。结论本报告在白种人NSCLC患者中进行,显示irAEs的出现与预后相关。在多变量分析中,irAE的发生仍是尼古鲁单抗疗效的独立指标(HR 1.44 [95%CI:1.22-1.71] p <0.0001)。结论本报告在白种人NSCLC患者中进行,显示irAEs的出现与预后相关。在多变量分析中,irAE的发生仍是尼古鲁单抗疗效的独立指标(HR 1.44 [95%CI:1.22-1.71] p <0.0001)。结论本报告在白种人NSCLC患者中进行,显示irAEs的出现与预后相关。
更新日期:2019-12-20
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