Department of Otorhinolaryngology-Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan;
Department of Oncology, School of Medicine, Yokohama City University, Yokohama, Japan.
Anticancer Res. 2022 Sep;42(9):4477-4484. doi: 10.21873/anticanres.15948.
BACKGROUND/AIM: This Japanese single-center retrospective cohort study aimed to evaluate the real-world therapeutic outcomes of pembrolizumab or pembrolizumab plus chemotherapy (pembrolizumab regimen) as first-line therapy for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
Thirty-two Japanese patients with R/M SCCHN treated with the pembrolizumab regimen between January 2020 and January 2022 were analyzed. The primary endpoint of the study was overall survival.
The median follow-up duration was 9.8 months (range=1.6-25.1 months). Fourteen patients received pembrolizumab alone, whereas the others received pembrolizumab with chemotherapy. The 1-year overall and progression-free survival rates were 64.5% (95% CI=38.9-81.6) and 54.9% (95% CI=33.9-71.8), respectively. The objective response rate was 56.2%. The Kaplan-Meier analysis showed that patients with favorable objective responses and an Eastern Cooperative Oncology Group performance status of 0 had longer survival. Immune-related adverse events (irAEs) occurred in 16 out of 32 patients (50.0%) during treatment; however, there were no irAEs greater than grade 4.
The observed therapeutic efficacy and safety of pembrolizumab in real-world clinical practice was consistent with the data of the KEYNOTE-048 trial.
背景/目的：本项日本单中心回顾性队列研究旨在评估帕博利珠单抗或帕博利珠单抗联合化疗（帕博利珠单抗方案）作为复发性/转移性头颈部鳞状细胞癌（R/M SCCHN）患者一线治疗的真实世界疗效。
分析了 2020 年 1 月至 2022 年 1 月期间接受帕博利珠单抗方案治疗的 32 例 R/M SCCHN 日本患者。该研究的主要终点为总生存期。
中位随访时间为 9.8 个月（范围 1.6-25.1 个月）。14 例患者单独接受了帕博利珠单抗治疗，而其他患者接受了帕博利珠单抗联合化疗。1 年总生存率和无进展生存率分别为 64.5%（95%CI=38.9-81.6）和 54.9%（95%CI=33.9-71.8）。客观缓解率为 56.2%。Kaplan-Meier 分析显示，客观缓解良好和东部肿瘤协作组体能状态为 0 的患者生存时间更长。在治疗期间，32 例患者中有 16 例（50.0%）发生了免疫相关不良事件（irAEs）；然而，没有发生大于 4 级的 irAEs。
在真实世界临床实践中观察到的帕博利珠单抗的治疗效果和安全性与 KEYNOTE-048 试验的数据一致。
