Immunotherapy for head and neck cancer: Recent advances and future directions.
Immunotherapy for head and neck cancer: Recent advances and future directions.
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DOI：
10.1016/j.oraloncology.2019.104460
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发表时间：
2019-12
期刊：
影响因子：
4.8
通讯作者：
Ferris RL
中科院分区：
文献类型：
--
作者：
Cramer JD;Burtness B;Ferris RL
三个随机III期试验现已确凿地证明，暴露于PD-1抑制剂可延长复发/转移（R/M） HNSCC的生存期，并且很明显，此类药物应用于所有无禁忌症的患者的管理。其中两项III期随机试验显示，抗pd1抗体nivolumab和pembrolizumab优于研究人员选择的二线铂难治R/M HNSCC化疗。最近，一项III期随机试验KEYNOTE-048显示，在所有患者中，派姆单抗联合化疗优于EXTREME方案（顺式或卡铂、5-氟尿嘧啶（5-FU）和西妥昔单抗），并且派姆单抗单药治疗在一线R/M HNSCC中肿瘤表达PD-L1的患者中优于。Pembrolizumab目前已被批准用于所有R/M型HNSCC患者的PD-L1表达疾病（联合阳性评分≥1）或化疗联合治疗。因此，PD-L1生物标志物检测将常规用于R/M HNSCC，这采用了一种结合免疫细胞染色的评分系统，称为联合阳性评分（CPS）。此外，对于85%的PD-L1 CPS≥1的患者，临床判断将指导派姆单抗单药治疗或派姆单抗联合化疗的选择，直到更详细的临床数据即将出现，以更好地为这一决定提供信息。在本文中，我们将讨论导致这些治疗进展的临床试验，我们将回顾先前未经治疗的局部晚期疾病的临床试验的初步结果，以及使用检查点抑制剂、共刺激激动剂和治疗性疫苗的新组合的临床试验。
Three randomized phase III trials have now conclusively proven that exposure to a PD-1 inhibitor prolongs survival in recurrent/metastatic (R/M) HNSCC, and it is clear that such agents should be used in the management of all patients who do not have contraindications to their use. Two of these phase III randomized trials showed that the anti-PD1 antibodies nivolumab and pembrolizumab were superior to investigators′ choice chemotherapy in second-line platinum-refractory R/M HNSCC. Recently, a third phase III randomized trial, KEYNOTE-048, showed that pembrolizumab with chemotherapy was superior to the EXTREME regimen (cis- or carboplatin, 5-fluorouracil (5-FU) and cetuximab) in all patients, and pembrolizumab monotherapy was superior in patients whose tumors express PD-L1 in first-line R/M HNSCC. Pembrolizumab is now approved as monotherapy in PD-L1 expressing disease (combined positive score ≥1) or in combination with chemotherapy for all patients with R/M HNSCC. Thus, PD-L1 biomarker testing will be routinely used in R/M HNSCC, and this employs a scoring system that incorporates immune cell staining, referred to as the combined positive score (CPS). Additionally, for the 85% of patients with PD-L1 CPS ≥1, clinical judgment will guide the choice of pembrolizumab monotherapy or pembrolizumab plus chemotherapy, until more detailed clinical data are forthcoming to better inform this decision. In this article we discuss the clinical trials leading to these therapeutic advances and we will review initial results from clinical trials in previously untreated, locally advanced disease, and those using novel combinations of checkpoint inhibitors, co-stimulatory agonists, and therapeutic vaccines.
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