纳武利尤单抗治疗复发性/不可切除食管鳞癌的疗效和生存：来自大型多机构队列的真实世界临床数据。
Efficacy and survival of nivolumab treatment for recurrent/unresectable esophageal squamous-cell carcinoma: real-world clinical data from a large multi-institutional cohort.
机构信息
Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2, Yamada-Oka, Suita, Osaka, 565-0871, Japan.
Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
出版信息
Esophagus. 2024 Jul;21(3):319-327. doi: 10.1007/s10388-024-01056-w. Epub 2024 May 8.
BACKGROUND
Real-world clinical outcomes of and prognostic factors for nivolumab treatment for esophageal squamous-cell carcinoma (ESCC) remain unclear. This study aimed to evaluate real-world outcomes of nivolumab monotherapy in association with relevant clinical parameters in recurrent/unresectable advanced ESCC patients.
METHODS
This population-based multicenter cohort study included a total of 282 patients from 15 institutions with recurrent/unresectable advanced ESCC who received nivolumab as a second-line or later therapy between 2014 and 2022. Data, including the best overall response, progression-free survival (PFS), and overall survival (OS), were retrospectively collected from these patients.
RESULTS
Objective response and disease control rates were 17.0% and 47.9%, respectively. The clinical response to nivolumab treatment significantly correlated with development of overall immune-related adverse events (P < .0001), including rash (P < .0001), hypothyroidism (P = .03), and interstitial pneumonia (P = .004). Organ-specific best response rates were 20.6% in lymph nodes, 17.4% in lungs, 15.4% in pleural dissemination, and 13.6% in primary lesions. In terms of patient survival, the median OS and PFS was 10.9 and 2.4 months, respectively. Univariate analysis of OS revealed that performance status (PS; P < .0001), number of metastatic organs (P = .019), C-reactive protein-to-albumin ratio (CAR; P < .0001), neutrophil-lymphocyte ratio (P = .001), and PMI (P = .024) were significant. Multivariate analysis further identified CAR [hazard ratio (HR) = 1.61, 95% confidence interval (CI) 1.15-2.25, P = .0053)] in addition to PS (HR = 1.65, 95% CI 1.23-2.22, P = .0008) as independent prognostic parameters.
CONCLUSIONS
CAR and PS before nivolumab treatment are useful in predicting long-term survival in recurrent/unresectable advanced ESCC patients with second-line or later nivolumab treatment.
TRIAL REGISTRATION
UMIN000040462.
背景
纳武利尤单抗治疗食管鳞状细胞癌（ESCC）的真实世界临床结局和预后因素仍不清楚。本研究旨在评估纳武利尤单抗单药治疗复发性/不可切除的晚期 ESCC 患者的真实世界结局，并结合相关临床参数进行分析。
方法
本研究为基于人群的多中心队列研究，共纳入 282 例来自 15 家机构的复发性/不可切除的晚期 ESCC 患者，这些患者在 2014 年至 2022 年间接受了纳武利尤单抗二线或后线治疗。从这些患者中回顾性收集了包括最佳总体反应、无进展生存期（PFS）和总生存期（OS）在内的数据。
结果
客观缓解率和疾病控制率分别为 17.0%和 47.9%。纳武利尤单抗治疗的临床反应与总免疫相关不良事件的发生显著相关（P<0.0001），包括皮疹（P<0.0001）、甲状腺功能减退症（P=0.03）和间质性肺炎（P=0.004）。针对特定器官的最佳反应率分别为淋巴结 20.6%、肺部 17.4%、胸膜扩散 15.4%和原发灶 13.6%。在患者生存方面，中位 OS 和 PFS 分别为 10.9 和 2.4 个月。OS 的单因素分析显示，表现状态（PS；P<0.0001）、转移器官数量（P=0.019）、C 反应蛋白与白蛋白比值（CAR；P<0.0001）、中性粒细胞与淋巴细胞比值（P=0.001）和血小板与单核细胞比值（PMI；P=0.024）是显著的预后因素。多因素分析进一步确定了 CAR[风险比（HR）=1.61，95%置信区间（CI）1.15-2.25，P=0.0053]和 PS（HR=1.65，95%CI 1.23-2.22，P=0.0008）是二线或后线纳武利尤单抗治疗复发性/不可切除的晚期 ESCC 患者的独立预后因素。
结论
CAR 和纳武利尤单抗治疗前的 PS 可用于预测二线或后线纳武利尤单抗治疗的复发性/不可切除的晚期 ESCC 患者的长期生存。
试验注册
UMIN000040462。
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