尽管免疫检查点抑制剂（ICIs），例如纳武利尤单抗（nivolumab）已被证明可以延长生存期，但复发/转移性头颈鳞状细胞癌（R/M SCCHN）的预后很差。我们研究了在为 R/M SCCHN 患者选择合适的治疗策略时预测纳武单抗疗效的因素。分析了 2017 年 5 月至 2021 年 10 月期间接受纳武单抗治疗的 44 名日本 R/M SCCHN 患者。该研究的主要终点是总生存期（OS）。我们将治疗前肿瘤大小 (PTS) 定义为所有可测量病灶大小的总和，将肿瘤生长率 (TGR) 定义为用于确定治疗反应的 CT 扫描中最大肿瘤直径的总生长率除以CT 扫描之间的间隔。受试者工作特征 (ROC) 曲线用于确定 OS 的 PTS 和 TGR 的截止点。采用Cox比例风险回归分析来检查各种因素之间的关系，包括患者特征、PTS和TGR以及治疗结果。在多变量分析中，东部肿瘤合作组（ECOG）表现状态（PS）评分≥1，进展性疾病 (PD) 作为最佳总体缓解 (BOR) 和 TGR >0.60%/天是 R/M-SCCHN 患者 OS 不良的独立危险因素。较高的 TGR、较差的 PS 和 PD 作为 BOR 可能是预后因素适用于 R/M SCCHN 患者。版权所有 © 2023，国际抗癌研究所（George J. Delinasios 博士），保留所有权利。

The prognosis of recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) is poor, although immune checkpoint inhibitors (ICIs), such as nivolumab, have been shown to prolong survival. We investigated the factors that predict the efficacy of nivolumab when selecting an appropriate treatment strategy for patients with R/M SCCHN.Forty-four Japanese patients with R/M SCCHN treated with nivolumab between May 2017 and October 2021 were analyzed. The primary endpoint of the study was overall survival (OS). We defined pre-treatment tumor size (PTS) as the sum of the size of all measurable lesions, and tumor growth rate (TGR) as the total growth rate of the largest tumor diameter on CT scans taken to determine treatment response, divided by the interval between CT scans. Receiver operating characteristic (ROC) curves were used to identify the cutoff points of PTS and TGR for OS. Cox proportional hazards regression analysis was performed to examine the relationships between various factors, including patient characteristics, PTS, and TGR, as well as treatment outcomes.In multivariate analysis, Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≥1, progressive disease (PD) as best overall response (BOR), and TGR >0.60%/day were independent risk factors for poor OS in patients with R/M-SCCHN.Higher TGR, poor PS, and PD as BOR may be prognostic factors in patients with R/M SCCHN.Copyright © 2023, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.