Kodama Hiroyuki, Kadowaki Shigenori, Ishizuka Yasunobu, Wakabayashi Munehiro, Sakakida Tomoki, Honda Kazunori, Masuishi Toshiki, Narita Yukiya, Taniguchi Hiroya, Ando Masashi, Kishikawa Toshihiro, Terada Hoshino, Beppu Shintaro, Nishikawa Daisuke, Suzuki Hidenori, Hanai Nobuhiro, Muro Kei
Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.
Department of Head and Neck Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.
Int J Clin Oncol. 2025 Mar;30(3):480-488. doi: 10.1007/s10147-025-02698-1. Epub 2025 Jan 14.
Nivolumab is the standard treatment for platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M-HNSCC). Several studies have reported the efficacy of paclitaxel plus cetuximab (PC) combination therapy in this patient population.
We conducted a retrospective analysis of patients with platinum-refractory R/M-HNSCC treated with nivolumab or PC at our institution between January 2015 and March 2022. Eligibility criteria included histologically confirmed HNSCC, ECOG performance status (PS) 0-2, with platinum-refractory R/M disease, defined as recurrence or disease progression within 6 months after platinum-based definitive chemoradiotherapy.
The baseline characteristics of the 56 patients (21 PC/35 nivolumab) were ECOG PS 1-2 (76/54%), metastatic sites ≥ 2 (33/46%), local recurrence (62/23%), and median tumor size (43.2/26.2 mm). Median progression-free survival (mPFS) tended to favor PC over nivolumab (4.3/2.7 months, hazard ratio [HR]: 0.7, p = 0.41), and median overall survival tended to be inferior for PC (8.0/23.2 months, HR: 1.58, p = 0.20). Similar results were obtained after adjusting for several relevant factors. The objective response rate was numerically higher with PC (31/19%). Grade 3/4 adverse events were more frequent with PC (29/6%), and the most prevalent were leukopenia (19%) for PC and liver dysfunction (6%) for nivolumab. Subsequent treatment with PC and nivolumab was administered to 75% and 72% of patients, respectively; the mPFS of these patients was significantly lower with PC (1.6/9.2 months, HR: 9.9, p < 0.001).
Both PC and nivolumab are viable treatment options for platinum-refractory R/M-HNSCC, though their efficacy and safety profiles should be carefully considered.
纳武利尤单抗是铂类难治性复发/转移性头颈部鳞状细胞癌（R/M-HNSCC）的标准治疗方案。多项研究报道了紫杉醇联合西妥昔单抗（PC）的联合疗法在该患者群体中的疗效。
我们对2015年1月至2022年3月期间在我院接受纳武利尤单抗或PC治疗的铂类难治性R/M-HNSCC患者进行了回顾性分析。纳入标准包括组织学确诊的HNSCC、东部肿瘤协作组（ECOG）体能状态（PS）为0-2、患有铂类难治性R/M疾病，定义为在铂类确定性放化疗后6个月内复发或疾病进展。
56例患者（21例接受PC治疗/35例接受纳武利尤单抗治疗）的基线特征为ECOG PS 1-2（76/54%）、转移部位≥2个（33/46%）、局部复发（62/23%）以及中位肿瘤大小（43.2/26.2 mm）。中位无进展生存期（mPFS）倾向于PC优于纳武利尤单抗（4.3/2.7个月，风险比[HR]：0.7，p = 0.41），而PC的中位总生存期倾向于较差（8.0/23.2个月，HR：1.58，p = 0.20）。在对多个相关因素进行调整后，得到了类似的结果。PC的客观缓解率在数值上更高（31/19%）。3/4级不良事件在PC组更常见（29/6%），最常见的是PC组的白细胞减少（19%）和纳武利尤单抗组的肝功能障碍（6%）。分别有75%和72%的患者随后接受了PC和纳武利尤单抗治疗；这些患者的mPFS在PC组显著更低（1.6/9.2个月，HR：9.9，p < 0.001）。
对于铂类难治性R/M-HNSCC，PC和纳武利尤单抗都是可行的治疗选择，不过它们的疗效和安全性特征应仔细考虑。
