Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Department of Head and Neck Surgery, National Kyushu Cancer Center, Fukuoka, Japan.
Anticancer Res. 2022 Jul;42(7):3653-3664. doi: 10.21873/anticanres.15854.
BACKGROUND/AIM: This study investigated the effectiveness of pembrolizumab with or without chemotherapy on advanced-stage head and neck cancer (HNC), including nasopharyngeal, sinonasal cavity and external auditory canal cancer, in a real-world setting.
We retrospectively collected data from 97 HNC patients who were treated with pembrolizumab alone (n=60) or with chemotherapy (n=37), and we investigated the association between clinicopathological findings and treatment response or prognosis.
Patients treated with pembrolizumab and chemotherapy had a 1-year overall survival (OS) of 72.8%, objective response rate (ORR) of 48.6%, and serious (≥G3) adverse events (AEs) of 29.7%. Patients treated with pembrolizumab alone had a 1-year OS of 51.9%, ORR of 21.7%, and ≥G3 AEs of 6.7%. Both the ORR and disease control rate (DCR) in the pembrolizumab with chemotherapy group were significantly better than those in the pembrolizumab group (p=0.074 and p=0.00101, respectively). Among patients with distant metastasis, patients on pembrolizumab with chemotherapy achieved significantly better OS than pembrolizumab alone (p=0.0039). Among patients in the pembrolizumab group, both AE-positive and better performance status were associated with longer OS (p=0.011 and p=0.0037, respectively).
Our real-world experience reinforces the durability and effectiveness of pembrolizumab for HNC patients. Additionally, our results suggest that pembrolizumab with chemotherapy might be recommended for patients with distant metastasis and no prior treatment. Further studies are needed to determine the optimal treatment strategy for HNC.
背景/目的：本研究旨在真实世界环境中，调查帕博利珠单抗联合或不联合化疗治疗晚期头颈部癌（HNC），包括鼻咽癌、鼻腔鼻窦和外耳道癌的疗效。
我们回顾性收集了 97 例接受帕博利珠单抗单药治疗（n=60）或联合化疗治疗（n=37）的 HNC 患者的数据，并研究了临床病理特征与治疗反应或预后之间的关系。
接受帕博利珠单抗联合化疗的患者 1 年总生存率（OS）为 72.8%，客观缓解率（ORR）为 48.6%，严重（≥G3）不良事件（AE）发生率为 29.7%。接受帕博利珠单抗单药治疗的患者 1 年 OS 为 51.9%，ORR 为 21.7%，≥G3 AE 发生率为 6.7%。联合化疗组的 ORR 和疾病控制率（DCR）均显著优于单药组（p=0.074 和 p=0.00101）。在远处转移的患者中，接受帕博利珠单抗联合化疗的患者 OS 显著优于帕博利珠单抗单药组（p=0.0039）。在帕博利珠单抗组中，AE 阳性和更好的表现状态与更长的 OS 相关（p=0.011 和 p=0.0037）。
我们的真实世界经验证实了帕博利珠单抗治疗 HNC 患者的持久性和有效性。此外，我们的结果表明，对于远处转移且无既往治疗的患者，帕博利珠单抗联合化疗可能是一种推荐的治疗方法。需要进一步的研究来确定 HNC 的最佳治疗策略。
