Nishimura Ari, Ishida Chie, Tanaka Akihisa, Kimura Takahiro, Yoshii Yumi, Uemura Hirokazu, Takeda Masayuki, Kitahara Tadashi
Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, 840 Shijo-Cho, Kashihara-City, Nara, 634-8521, Japan.
Department of Cancer Genomics and Medical Oncology, Nara Medical University, Kashihara-City, Japan.
Eur Arch Otorhinolaryngol. 2025 Apr;282(4):2071-2076. doi: 10.1007/s00405-024-09065-2. Epub 2024 Nov 14.
Systemic chemotherapy is the primary treatment strategy for recurrent or metastatic squamous cell carcinoma of the head and neck (RM-SCCHN). Therapeutic strategies are changing considerably with the introduction of molecular-targeted and immune checkpoint inhibitor (ICI) therapies in addition to conventional cytotoxic therapy. The CheckMate-141 and KEYNOTE-048 trials have enabled the use of ICIs as first-line treatment to improve the overall prognosis of RM-SCCHN. However, background factors affecting treatment responses, including performance status (PS), remain poorly defined. Therefore, we investigated the effect of PS in patients treated with nivolumab.
We retrospectively reviewed the treatment outcomes and backgrounds of 31 patients with RM-SCCHN who received nivolumab monotherapy between April 2017 and March 2023.
The patient background was male/female = 29/2, median age was 68 years (range 39-85), PS0/1/2 = 14/15/2, and oral/oropharynx/hypopharynx/larynx = 2/12/12/5. Median overall survival was 8.0 months (95% confidence interval [CI]: 4.3-30.6 months), median progression-free survival was 3.0 months (95% CI 1.7-9.1 months), and objective response rate was 22.6% (95% CI 11.1-40.1%). Immune-related adverse events of grade 3 or higher were observed in three patients (9.7%). Eight (29.6%) of the 27 patients (excluding four patients who maintained complete response for over 2 years) were successfully transferred to post-treatment. In the multivariate analysis, Eastern Cooperative Oncology Group (ECOG) PS (Hazard Ratio: 9.87, 95% CI 1.79-54.56) was associated with poor survival.
The efficacy of nivolumab is reduced in patients with poor PS.
全身化疗是复发性或转移性头颈部鳞状细胞癌（RM-SCCHN）的主要治疗策略。除传统细胞毒性疗法外，分子靶向和免疫检查点抑制剂（ICI）疗法的引入使治疗策略发生了很大变化。CheckMate-141和KEYNOTE-048试验使ICI能够作为一线治疗使用，以改善RM-SCCHN的总体预后。然而，包括体能状态（PS）在内的影响治疗反应的背景因素仍未明确界定。因此，我们研究了PS在接受纳武利尤单抗治疗的患者中的作用。
我们回顾性分析了2017年4月至2023年3月期间接受纳武利尤单抗单药治疗的31例RM-SCCHN患者的治疗结果和背景。
患者背景为男性/女性=29/2，中位年龄为68岁（范围39-85岁），PS0/1/2=14/15/2，口腔/口咽/下咽/喉=2/12/12/5。中位总生存期为8.0个月（95%置信区间[CI]：4.3-30.6个月），中位无进展生存期为3.0个月（95%CI 1.7-9.1个月），客观缓解率为22.6%（95%CI 11.1-40.1%）。3例患者（9.7%）观察到3级或更高等级的免疫相关不良事件。27例患者中的8例（29.6%）（不包括4例维持完全缓解超过2年的患者）成功转为后续治疗。在多变量分析中，东部肿瘤协作组（ECOG）PS（风险比：9.87，95%CI 1.79-54.56）与生存不良相关。
PS较差的患者中纳武利尤单抗的疗效降低。
