Real-world Therapeutic Outcomes of the Pembrolizumab Regimen as First-line Therapy for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: A Single-center Retrospective Cohort Study in Japan
Real-world Therapeutic Outcomes of the Pembrolizumab Regimen as First-line Therapy for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: A Single-center Retrospective Cohort Study in Japan
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DOI：
10.21873/anticanres.15948
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发表时间：
2022-09-01
影响因子：
2
通讯作者：
Oridate, Nobuhiko
中科院分区：
文献类型：
--
作者：
Sano, Daisuke;Tokuhisa, Motohiko;Oridate, Nobuhiko
背景/目的：这项日本单中心回顾性队列研究旨在评估派姆单抗或派姆单抗联合化疗（派姆单抗方案）作为头颈部复发/转移性鳞状细胞癌（R/M SCCHN）患者一线治疗的现实治疗结果。患者和方法：分析了2020年1月至2022年1月期间接受派姆单抗治疗的32例日本R/M SCCHN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名患者单独接受派姆单抗治疗，而其他患者接受派姆单抗联合化疗。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）。客观有效率为56.2%。Kaplan-Meier分析显示，客观反应良好且东部肿瘤合作组表现状态为0的患者生存期更长。32例患者中有16例（50.0%）在治疗期间发生免疫相关不良事件（irAEs）；然而，没有超过4级的irae。结论：在实际临床实践中观察到的派姆单抗的疗效和安全性与KEYNOTE-048试验的数据一致。
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). Patients and 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. Conclusion: The observed therapeutic efficacy and safety of pembrolizumab in real -world clinical practice was consistent with the data of the KEYNOTE-048 trial.