化疗免疫治疗的晚期非小细胞肺癌真实世界患者中与免疫治疗相关的不良事件：一项斯平纳克研究的亚分析
Immunotherapy-related adverse events in real-world patients with advanced non-small cell lung cancer on chemoimmunotherapy: a Spinnaker study sub-analysis.
作者信息
Anpalakhan Shobana, Huddar Prerana, Behrouzi Roya, Signori Alessio, Cave Judith, Comins Charles, Cortellini Alessio, Addeo Alfredo, Escriu Carles, McKenzie Hayley, Barone Gloria, Murray Lisa, Pinato David J, Ottensmeier Christian, Campos Sara, Muthuramalingam Sethupathi, Chan Samuel, Gomes Fabio, Banna Giuseppe L
机构信息
Portsmouth Hospitals University NHS Trust, Portsmouth, United Kingdom.
The Christie NHS Foundation Trust, Manchester, United Kingdom.
出版信息
Front Oncol. 2023 May 31;13:1163768. doi: 10.3389/fonc.2023.1163768. eCollection 2023.
BACKGROUND
The Spinnaker study evaluated survival outcomes and prognostic factors in patients with advanced non-small-cell lung cancer receiving first-line chemoimmunotherapy in the real world. This sub-analysis assessed the immunotherapy-related adverse effects (irAEs) seen in this cohort, their impact on overall survival (OS) and progression-free survival (PFS), and related clinical factors.
METHODS
The Spinnaker study was a retrospective multicentre observational cohort study of patients treated with first-line pembrolizumab plus platinum-based chemotherapy in six United Kingdom and one Swiss oncology centres. Data were collected on patient characteristics, survival outcomes, frequency and severity of irAEs, and peripheral immune-inflammatory blood markers, including the neutrophil-to-lymphocyte ratio (NLR) and systemic immune-inflammation index (SII).
RESULTS
A total of 308 patients were included; 132 (43%) experienced any grade irAE, 100 (32%) Grade 1-2, and 49 (16%) Grade 3-4 irAEs. The median OS in patients with any grade irAES was significantly longer (17.5 months [95% CI, 13.4-21.6 months]) than those without (10.1 months [95% CI, 8.3-12.0 months]) (p<0.001), either if Grade 1-2 (p=0.003) or Grade 3-4 irAEs (p=0.042). The median PFS in patients with any grade irAEs was significantly longer (10.1 months [95% CI, 9.0-11.2 months]) than those without (6.1 months [95% CI, 5.2-7.1 months]) (p<0.001), either if Grade 1-2 (p=0.011) or Grade 3-4 irAEs (p=0.036). A higher rate of irAEs of any grade and specifically Grade 1-2 irAEs correlated with NLR <4 (p=0.013 and p=0.018), SII <1,440 (p=0.029 ad p=0.039), response to treatment (p=0.001 and p=0.034), a higher rate of treatment discontinuation (p<0.00001 and p=0.041), and the NHS-Lung prognostic classes (p=0.002 and p=0.008).
CONCLUSIONS
These results confirm survival outcome benefits in patients with irAEs and suggest a higher likelihood of Grade 1-2 irAEs in patients with lower NLR or SII values or according to the NHS-Lung score.
背景
Spinnaker研究评估了在现实世界中接受一线化疗免疫疗法的晚期非小细胞肺癌患者的生存结果和预后因素。该亚分析评估了该队列中出现的免疫疗法相关不良反应（irAE）、它们对总生存期（OS）和无进展生存期（PFS）的影响以及相关临床因素。
方法
Spinnaker研究是一项回顾性多中心观察性队列研究，研究对象为在英国六个和瑞士一个肿瘤中心接受一线帕博利珠单抗联合铂类化疗的患者。收集了患者特征、生存结果、irAE的频率和严重程度以及外周免疫炎症血液标志物的数据，包括中性粒细胞与淋巴细胞比值（NLR）和全身免疫炎症指数（SII）。
结果
共纳入308例患者；132例（43%）出现任何级别的irAE，100例（32%）为1-2级，49例（16%）为3-4级irAE。出现任何级别的irAE的患者的中位OS显著长于未出现的患者（17.5个月[95%CI，13.4-21.6个月]）（10.1个月[95%CI，8.3-12.0个月]）（p<0.001），无论是1-2级（p=0.003）还是3-4级irAE（p=0.042）。出现任何级别的irAE的患者的中位PFS显著长于未出现的患者（10.1个月[95%CI，9.0-11.2个月]）（6.1个月[95%CI，5.2-7.1个月]）（p<0.001），无论是1-2级（p=0.011）还是3-4级irAE（p=0.036）。任何级别的irAE，特别是1-2级irAE的发生率较高与NLR<4（p=0.013和p=0.018）、SII<1440（p=0.029和p=0.039）、对治疗的反应（p=0.001和p=0.034）、较高的治疗中断率（p<0.00001和p=0.041）以及NHS-Lung预后分类（p=0.002和p=0.008）相关。
结论
这些结果证实了irAE患者的生存结果益处，并表明NLR或SII值较低或根据NHS-Lung评分的患者发生1-2级irAE的可能性更高。
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