Sun Bo, Gao Jin Qi, Li Ruo Jie, Song Lei, Li Na, Gao Fei
Department of Oral and Maxillofacial Surgery, The Second Hospital of Dalian Medical University, Dalian, Liaoning, China.
Department of Intervention, The Second Hospital of Dalian Medical University, Dalian, Liaoning, China.
Front Immunol. 2025 Jul 23;16:1615440. doi: 10.3389/fimmu.2025.1615440. eCollection 2025.
This study investigated the clinical efficacy and safety of CalliSpheres drug-eluting bead transarterial chemoembolization (DEB-TACE) combined with programmed death protein (PD)-1 inhibitors for treatment of unresectable head and neck squamous cell carcinoma (HNSCC).
Clinical data of 31 patients with unresectable HNSCC were retrospectively analyzed. All patients received local treatment with DEB-TACE combined with systemic PD-1 inhibitor. Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria were used to evaluate the tumor response at 1, 3 and 6 months after the first treatment. Progression-free survival and overall survival were recorded. The changes in quality of life before and after treatment and adverse reactions during treatment were recorded.
Patients were treated with DEB-TACE 51 (average 1.65 ± 0.51) times. At 1, 3 and 6 months after the first treatment, objective response rate was 96.77%, 87.09% and 74.19%, and disease control rate was 100%, 96.77% and 83.87%, respectively. As of October 31, 2024, the mean follow-up was 21.71 ± 9.56 months, median survival time was 9.0 months, and the median progression-free survival was 19.0 months. The adverse reactions related to DEB-TACE were mainly fever, pain, nausea and vomiting; all of which were mild and relieved after symptomatic treatment. Three patients had mild skin ulceration in the embolic area, which healed after symptomatic treatment, and no serious complications such as ectopic embolism occurred. The adverse reactions associated with PD-1 inhibitor treatment were mainly fatigue, hypothyroidism and rash. Most of these were grade 1/2, three patients had grade 3 adverse reactions, but no grade 4 adverse reactions occurred. One month after the first treatment, the scores of physical function, emotional function and general health status increased, and the scores of pain, insomnia and anorexia decreased, and quality of life was significantly improved.
Combination of DEB-TACE with PD-1 inhibitors is safe and effective for treatment of unresectable HNSCC, significantly improves quality of life, and warrants clinical promotion and application.
本研究探讨了载药微球经动脉化疗栓塞术（DEB-TACE）联合程序性死亡蛋白（PD）-1抑制剂治疗不可切除头颈部鳞状细胞癌（HNSCC）的临床疗效和安全性。
回顾性分析31例不可切除HNSCC患者的临床资料。所有患者均接受DEB-TACE局部治疗联合全身PD-1抑制剂治疗。采用改良实体瘤疗效评价标准（mRECIST）评估首次治疗后1、3和6个月时的肿瘤反应。记录无进展生存期和总生存期。记录治疗前后生活质量的变化以及治疗期间的不良反应。
患者接受DEB-TACE治疗51次（平均1.65±0.51次）。首次治疗后1、3和6个月时，客观缓解率分别为96.77%、87.09%和74.19%，疾病控制率分别为100%、96.77%和83.87%。截至2024年10月31日，平均随访时间为21.71±9.56个月，中位生存时间为9.0个月，中位无进展生存期为19.0个月。与DEB-TACE相关的不良反应主要为发热、疼痛、恶心和呕吐；均为轻度，经对症治疗后缓解。3例患者栓塞区域出现轻度皮肤溃疡，经对症治疗后愈合，未发生异位栓塞等严重并发症。与PD-1抑制剂治疗相关的不良反应主要为疲劳、甲状腺功能减退和皮疹。大多数为1/2级，3例患者出现3级不良反应，但未发生4级不良反应。首次治疗后1个月，身体功能、情绪功能和总体健康状况评分升高，疼痛、失眠和食欲减退评分降低，生活质量显著改善。
DEB-TACE联合PD-1抑制剂治疗不可切除HNSCC安全有效，显著改善生活质量，值得临床推广应用。
