Department of General Internal Medicine, Northern Medical Branch of the PLA General Hospital, Beijing, 100094, People's Republic of China.
Department of Stomatology, The 1st Medical Center of Chinese PLA General Hospital, Beijing, 100853, People's Republic of China.
Invest New Drugs. 2022 Dec;40(6):1282-1289. doi: 10.1007/s10637-022-01293-9. Epub 2022 Aug 16.
Although anti-programmed death receptor-1 (PD-1) agents have been evaluated in the neoadjuvant setting for the treatment of locally advanced head and neck cancer, including oral cavity squamous cell carcinoma (OCSCC), the overall response rate is modest. The aim of the present study was to evaluate the efficacy and safety of neoadjuvant nivolumab in combination with stereotactic body radiotherapy (SBRT) for the treatment of locally advanced OCSCC.
OCSCC patients who underwent surgical resection within 6 months of treatment with nivolumab plus SBRT from December 2018 to February 2021 were analyzed retrospectively.
All 30 eligible patients enrolled in this study well tolerated the neoadjuvant treatment with no serious adverse events (AEs). Of them, 27 patients (90.0%) achieved R0 resection, and 5 patients (16.7%) experienced procedure-associated complications. The complete response (CR), partial response (PR) and stable disease (SD) were 10.0%, 46.7% and 43.3% respectively. The major pathological response (MPR), complete pathological response (pCR) and clinical to pathological downstaging rate were 60.0%, 33.3% and 83.3% respectively. During the median follow-up period of 13.5 months, 26 patients (86.7%) who underwent surgical resection remained alive. The disease-free survival (DFS) and overall survival (OS) at 24 months were 70.4% and 76.4% respectively.
Neoadjuvant nivolumab plus SBRT is safe and efficacious, and could be used as a potential neoadjuvant option for the treatment of patients with locally advanced OCSCC.
尽管抗程序性死亡受体-1(PD-1)药物已在新辅助治疗局部晚期头颈部癌(包括口腔鳞状细胞癌[OCSCC])中进行了评估,但总体缓解率并不高。本研究旨在评估新辅助纳武利尤单抗联合立体定向体部放疗(SBRT)治疗局部晚期 OCSCC 的疗效和安全性。
回顾性分析了 2018 年 12 月至 2021 年 2 月期间接受纳武利尤单抗联合 SBRT 治疗后 6 个月内行手术切除的 OCSCC 患者。
本研究共纳入 30 例患者,均能很好地耐受新辅助治疗,无严重不良事件(AE)。其中 27 例(90.0%)达到 R0 切除,5 例(16.7%)发生与治疗相关的并发症。完全缓解(CR)、部分缓解(PR)和稳定疾病(SD)分别为 10.0%、46.7%和 43.3%。主要病理缓解(MPR)、完全病理缓解(pCR)和临床病理降期率分别为 60.0%、33.3%和 83.3%。在中位随访 13.5 个月期间,26 例(86.7%)接受手术切除的患者存活。24 个月时无疾病生存率(DFS)和总生存率(OS)分别为 70.4%和 76.4%。
新辅助纳武利尤单抗联合 SBRT 安全有效,可作为治疗局部晚期 OCSCC 患者的潜在新辅助选择。