Tahara Makoto, Kiyota Naomi, Nibu Ken-Ichi, Akamatsu Ayumi, Hoshino Tomohiro, Hayashi Ryuichi
Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Department of Medical Oncology and Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.
Int J Clin Oncol. 2021 Sep;26(9):1619-1627. doi: 10.1007/s10147-021-01949-1. Epub 2021 Jun 10.
On the basis of phase III CheckMate 141 results, nivolumab was approved for recurrent or metastatic head and neck cancer after undergoing platinum-containing chemotherapy in Japan. This post-marketing surveillance aimed to evaluate the safety and effectiveness of nivolumab for head and neck cancer in the real-world setting.
All patients with head and neck cancer who planned to receive nivolumab were centrally registered. This study monitored 607 patients for 6 months to assess nivolumab's safety, especially treatment-related adverse events (TRAEs) of special interest, and effectiveness.
TRAEs occurred in 36.1% patients, with no new safety signals. The most common TRAEs with grade ≥ 3 were interstitial lung disease (1.2%), diarrhea (0.8%), and hepatic function abnormal (0.7%). Meanwhile, thyroid dysfunction (10.2%), hepatic dysfunction (5.3%), and interstitial lung disease (4.1%) were the most common TRAE categories of special interest. Although the median time to the onset of each TRAE category of special interest was mostly 1-2 months, most of them occurred throughout the observation period; nonetheless, the majority of patients recovered or remitted. The 6-month survival rate was 55.9%.
Japanese patients with head and neck cancer treated with nivolumab in the real-world setting manifested no new safety signals.
clinicaltrials.jp: JapicCTI-184071.
基于III期CheckMate 141试验结果，纳武利尤单抗在日本被批准用于含铂化疗后复发或转移性头颈癌。本次上市后监测旨在评估纳武利尤单抗在真实世界中治疗头颈癌的安全性和有效性。
所有计划接受纳武利尤单抗治疗的头颈癌患者进行集中登记。本研究对607例患者进行了6个月的监测，以评估纳武利尤单抗的安全性，尤其是特别关注的治疗相关不良事件（TRAEs），以及有效性。
36.1%的患者发生了TRAEs，未发现新的安全信号。≥3级最常见的TRAEs为间质性肺病（1.2%）、腹泻（0.8%）和肝功能异常（0.7%）。同时，甲状腺功能障碍（10.2%）、肝功能障碍（5.3%）和间质性肺病（4.1%）是特别关注的最常见TRAEs类别。虽然各特别关注的TRAEs类别的中位发病时间大多为1 - 2个月，但大多数在整个观察期内发生；尽管如此，大多数患者恢复或缓解。6个月生存率为55.9%。
在真实世界中接受纳武利尤单抗治疗的日本头颈癌患者未表现出新的安全信号。
clinicaltrials.jp: JapicCTI-184071。
