Abstract：
OBJECTIVE: 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).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: The observed therapeutic efficacy and safety of pembrolizumab in real-world clinical practice was consistent with the data of the KEYNOTE-048 trial.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: The observed therapeutic efficacy and safety of pembrolizumab in real-world clinical practice was consistent with the data of the KEYNOTE-048 trial.
摘要：
目的：这项日本单中心回顾性队列研究旨在评估pembrolizumab或pembrolizumab联合化疗（pembrolizumab方案）作为复发/转移性头颈部鳞状细胞癌（R/MSCCHN）患者一线治疗的实际治疗结果。
方法：分析了2020年1月至2022年1月期间使用pembrolizumab方案治疗的32例日本R/MSCCHN患者。研究的主要终点是总生存期。
结果：中位随访时间为9.8个月（范围=1.6-25.1个月）。14名患者单独接受了pembrolizumab，而其他人则接受了pembrolizumab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），分别。客观有效率为56.2%。Kaplan-Meier分析显示，客观反应良好且东部肿瘤协作组表现状态为0的患者生存期更长。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（irAE）；然而，没有irAE大于4级。
结论：在实际临床实践中观察到的派姆单抗的治疗效果和安全性与KEYNOTE-048试验的数据一致。
方法：分析了2020年1月至2022年1月期间使用pembrolizumab方案治疗的32例日本R/MSCCHN患者。研究的主要终点是总生存期。
结果：中位随访时间为9.8个月（范围=1.6-25.1个月）。14名患者单独接受了pembrolizumab，而其他人则接受了pembrolizumab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），分别。客观有效率为56.2%。Kaplan-Meier分析显示，客观反应良好且东部肿瘤协作组表现状态为0的患者生存期更长。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（irAE）；然而，没有irAE大于4级。
结论：在实际临床实践中观察到的派姆单抗的治疗效果和安全性与KEYNOTE-048试验的数据一致。
