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.
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。