PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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).
UNASSIGNED: 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.
摘要：
■Spinnaker研究评估了在现实世界中接受一线化学免疫治疗的晚期非小细胞肺癌患者的生存结果和预后因素。这个子分析评估了在这个队列中看到的免疫疗法相关的不良反应（irAEs），它们对总生存期（OS）和无进展生存期（PFS）的影响，及相关临床因素。
Spinnaker研究是一项回顾性多中心观察性队列研究，在英国6个肿瘤中心和瑞士1个肿瘤中心进行了一线pembrolizumab联合铂类化疗治疗。收集了有关患者特征的数据，生存结果，IRAE的频率和严重程度，和外周免疫炎症血液标志物，包括中性粒细胞与淋巴细胞比率（NLR）和全身免疫炎症指数（SII）。
■共纳入308例患者；132例（43%）经历了任何级别的irAE，100（32%）1-2级和49（16%）3-4级IRAE。患有任何级别irAES的患者的中位OS（17.5个月[95％CI，13.4-21.6个月]）明显长于没有（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)。有任何级别irAE的患者的中位PFS（10.1个月[95％CI，9.0-11.2个月]）明显长于没有（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)。与NLR<4（p=0.013和p=0.018）相关的任何等级的irAE，特别是1-2级irAE的较高比率，SII<1,440（p=0.029adp=0.039），对治疗的反应（p=0.001和p=0.034），治疗中止率较高（p<0.00001和p=0.041），和NHS肺预后分类（p=0.002和p=0.008）。
■这些结果证实了irAE患者的生存结局获益，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。
Spinnaker研究是一项回顾性多中心观察性队列研究，在英国6个肿瘤中心和瑞士1个肿瘤中心进行了一线pembrolizumab联合铂类化疗治疗。收集了有关患者特征的数据，生存结果，IRAE的频率和严重程度，和外周免疫炎症血液标志物，包括中性粒细胞与淋巴细胞比率（NLR）和全身免疫炎症指数（SII）。
■共纳入308例患者；132例（43%）经历了任何级别的irAE，100（32%）1-2级和49（16%）3-4级IRAE。患有任何级别irAES的患者的中位OS（17.5个月[95％CI，13.4-21.6个月]）明显长于没有（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)。有任何级别irAE的患者的中位PFS（10.1个月[95％CI，9.0-11.2个月]）明显长于没有（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)。与NLR<4（p=0.013和p=0.018）相关的任何等级的irAE，特别是1-2级irAE的较高比率，SII<1,440（p=0.029adp=0.039），对治疗的反应（p=0.001和p=0.034），治疗中止率较高（p<0.00001和p=0.041），和NHS肺预后分类（p=0.002和p=0.008）。
■这些结果证实了irAE患者的生存结局获益，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。
