Background: Recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) has poor survival rates. Immunotherapy is the standard of care for R/M HNSCC, but objective responses occur in a minority of patients. Toll-like receptor (TLR) agonists promote antitumor immune responses and have been explored in clinical trials. Methods: A search for clinical trials using TLR agonists in HNSCC was performed under PRISMA guidelines. Data on patient characteristics, safety, and efficacy were collected and analyzed. Results: Three phase 1b trials with 40 patients and three phase 2 trials with 352 patients studying TLR8 and TLR9 agonists in combination with other treatment regimens for HNSCC were included. In phase 2 trials, there was no significant change in the objective response rate (RR = 1.13, CI 0.80–1.60) or association with increased grade 3+ adverse events (RR = 0.91, CI 0.76–1.11) associated with TLR agonist use. Conclusion: TLR agonists do not appear to provide additional clinical benefits or increase adverse events in the treatment of HNSCC. Given these results across multiple clinical trials and drug regimens, it is unlikely that additional trials of TLR agonists will demonstrate clinical benefits in HNSCC.
背景：复发性和转移性（R/M）头颈部鳞状细胞癌（HNSCC）的生存率较低。免疫疗法是R/M HNSCC的标准治疗方案，但仅有少数患者出现客观缓解。Toll样受体（TLR）激动剂可促进抗肿瘤免疫反应，并已在临床试验中进行探索。方法：根据PRISMA指南，对使用TLR激动剂治疗HNSCC的临床试验进行了检索。收集并分析了患者特征、安全性和疗效数据。结果：共纳入三项Ib期试验（涉及40例患者）和三项II期试验（涉及352例患者），这些试验研究了TLR8和TLR9激动剂联合其他治疗方案治疗HNSCC的效果。在II期试验中，使用TLR激动剂未显著改变客观缓解率（RR = 1.13，CI 0.80–1.60），也未显著增加3级及以上不良事件的发生率（RR = 0.91，CI 0.76–1.11）。结论：TLR激动剂在HNSCC治疗中似乎未提供额外的临床获益，也未增加不良事件。鉴于多项临床试验和药物方案均得出类似结果，进一步开展TLR激动剂试验不太可能证明其在HNSCC治疗中具有临床获益。
肿瘤(癌症)患者之家