Machiels Jean-Pascal, Tao Yungan, Burtness Barbara, Tahara Makoto, Licitra Lisa, Rischin Danny, Waldron John, Simon Christian, Gregoire Vincent, Harrington Kevin, Alves Gustavo Vasconcelos, Figueiredo Lima Iane Pinto, Pointreau Yoann, M Hughes Brett G, Aksoy Sercan, Hetnal Marcin, Ge Joy Y, Brown Holly, Cheng Jonathan, Bidadi Behzad, Siu Lillian L
Department of Medical Oncology, Institut Roi Albert II, Cliniques Universitaires Saint-Luc & Institut de Recherche Clinique et Expérimentale, Université Catholique de Louvain (UCLouvain), Avenue Hippocrate 10, Brussels, Belgium.
Department of Radiation Oncology, Gustave Roussy Cancer Campus, 114 Rue Edouard Vaillant, 94800, Villejuif, France.
Future Oncol. 2020 Jun;16(18):1235-1243. doi: 10.2217/fon-2020-0184. Epub 2020 Jun 3.
Current treatment guidelines for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) recommend multimodal treatment, including chemoradiation therapy (CRT) or surgery followed by radiation, with or without chemotherapy. The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials. For patients with locally advanced disease, Phase Ib data on the use of pembrolizumab in combination with chemoradiation have shown the approach to be safe and feasible. We describe here the design and rationale for KEYNOTE-412, a randomized, double-blind, Phase III trial investigating pembrolizumab or placebo administered concurrently with CRT and as maintenance treatment in patients with locally advanced HNSCC. Clinical Trial Registration: NCT03040999 (ClinicalTrials.gov).
目前针对局部晚期头颈部鳞状细胞癌（HNSCC）患者的治疗指南推荐多模式治疗，包括放化疗（CRT）或手术加放疗，可联合或不联合化疗。免疫检查点抑制剂帕博利珠单抗此前在大型III期试验中已证明对复发和/或转移性HNSCC具有抗肿瘤活性。对于局部晚期疾病患者，关于帕博利珠单抗联合放化疗的Ib期数据表明该方法安全可行。我们在此描述KEYNOTE-412的设计和原理，这是一项随机、双盲、III期试验，研究帕博利珠单抗或安慰剂与CRT同时给药并作为局部晚期HNSCC患者的维持治疗。临床试验注册：NCT03040999（ClinicalTrials.gov）。
