纳武利尤单抗对比研究者选择的治疗方案用于亚洲人群复发性或转移性头颈部鳞状细胞癌的随机III期临床试验（CheckMate 141）的两年随访
Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141).
作者信息
Yen Chia-Jui, Kiyota Naomi, Hanai Nobuhiro, Takahashi Shunji, Yokota Tomoya, Iwae Shigemichi, Shimizu Yasushi, Hong Ruey-Long, Goto Masahiro, Kang Jin-Hyoung, Li Wing Sum Kenneth, Ferris Robert L, Gillison Maura, Endo Toshimitsu, Jayaprakash Vijayvel, Tahara Makoto
机构信息
Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.
出版信息
Head Neck. 2020 Oct;42(10):2852-2862. doi: 10.1002/hed.26331. Epub 2020 Jun 24.
BACKGROUND
The present study evaluated the 2-year survival of the Asian population in the CheckMate 141 trial.
METHODS
The CheckMate 141 trial included patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). In the present study, 34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed.
RESULTS
The median overall survival (OS) was 12.1 and 6.2 months for the nivolumab and IC groups, respectively. The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively. In the nivolumab group, the patients with any treatment-related adverse events (TRAEs), including skin-related disorders, showed better OS than the patients without any TRAEs.
CONCLUSIONS
Nivolumab demonstrated prolonged OS benefits in the Asian population with platinum-refractory R/M SCCHN and a favorable safety profile. TRAEs, including skin-related disorders, may be favorable prognostic factors for nivolumab efficacy.
CLINICAL TRIAL REGISTRATION
NCT02105636.
背景
本研究评估了CheckMate 141试验中亚洲人群的2年生存率。
方法
CheckMate 141试验纳入了复发性或转移性（R/M）头颈部鳞状细胞癌（SCCHN）患者。在本研究中，分析了34例亚洲患者（纳武利尤单抗组：23例患者；研究者选择的治疗[IC]组：11例患者）。
结果
纳武利尤单抗组和IC组的中位总生存期（OS）分别为12.1个月和6.2个月。纳武利尤单抗组和IC组的2年OS率估计分别为22.7%和0%。在纳武利尤单抗组中，发生任何治疗相关不良事件（TRAEs）（包括皮肤相关疾病）的患者的OS优于未发生任何TRAEs的患者。
结论
纳武利尤单抗在铂类难治性R/M SCCHN的亚洲人群中显示出延长总生存期的益处且安全性良好。包括皮肤相关疾病在内的TRAEs可能是纳武利尤单抗疗效的有利预后因素。
临床试验注册
NCT02105636。
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