The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC)
The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC)
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DOI：
10.1186/s40425-019-0662-5
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发表时间：
2019-07-15
影响因子：
10.9
通讯作者：
Ferris, Robert L.
中科院分区：
文献类型：
--
作者：
Cohen, Ezra E. W.;Bell, R. Bryan;Ferris, Robert L.
头颈部癌症，包括唇癌和口腔癌、鼻腔癌、鼻旁窦癌、口咽癌、喉癌和鼻咽癌，在全世界每年有近700，000例新发病例和380，000例死亡，仅在美国每年就有超过10，000例死亡。需要改善复发和/或转移性头颈部鳞状细胞癌（HNSCC）患者的结局。2016年，美国食品和药物管理局（FDA）批准了第一批免疫抑制剂-抗PD-1免疫检查点抑制剂nivolumab和pembrolizumab -用于治疗铂类方案难治的头颈部复发性鳞状细胞癌（HNSCC）患者。欧盟委员会随后于2017年批准纳武利尤单抗用于治疗相同的患者人群，此后不久批准帕博利珠单抗单药治疗复发性或转移性HNSCC成人，其肿瘤表达PD-L1，肿瘤比例评分>= 50%，并且在含铂化疗期间或之后进展。然后在2019年，FDA批准PD-1抑制作为转移性或不可切除的复发性HNSCC患者的一线治疗，批准pembrolizumab联合铂和氟尿嘧啶用于所有HNSCC患者，并批准pembrolizumab作为肿瘤表达PD-L1综合阳性评分>= 1的HNSCC患者的单药。这些批准标志着自2006年以来这些患者的第一个新疗法，以及这种疾病的第一个免疫批准。鉴于这些用于治疗头颈癌患者的新疗法的引入，癌症免疫治疗学会（SITC）成立了一个专家委员会，负责为新兴免疫治疗提供共识建议，包括适当的患者选择，治疗序列，反应监测，不良事件管理和生物标志物检测。这些共识指南是帮助临床医生理解免疫疗法在这种疾病中的作用的基础，并使整个领域的使用标准化，以使患者受益。由于所讨论药物的批准、可用性和法规因国家而异，该小组仅关注FDA批准用于治疗美国患者的药物。
Head and neck cancers, including those of the lip and oral cavity, nasal cavity, paranasal sinuses, oropharynx, larynx and nasopharynx represent nearly 700,000 new cases and 380,000 deaths worldwide per annum, and account for over 10,000 annual deaths in the United States alone. Improvement in outcomes are needed for patients with recurrent and or metastatic squamous cell carcinoma of the head and neck (HNSCC). In 2016, the US Food and Drug Administration (FDA) granted the first immunotherapeutic approvals - the anti-PD-1 immune checkpoint inhibitors nivolumab and pembrolizumab - for the treatment of patients with recurrent squamous cell carcinoma of the head and neck (HNSCC) that is refractory to platinum-based regimens. The European Commission followed in 2017 with approval of nivolumab for treatment of the same patient population, and shortly thereafter with approval of pembrolizumab monotherapy for the treatment of recurrent or metastatic HNSCC in adults whose tumors express PD-L1 with a >= 50% tumor proportion score and have progressed on or after platinum-containing chemotherapy. Then in 2019, the FDA granted approval for PD-1 inhibition as first-line treatment for patients with metastatic or unresectable, recurrent HNSCC, approving pembrolizumab in combination with platinum and fluorouracil for all patients with HNSCC and pembrolizumab as a single agent for patients with HNSCC whose tumors express a PD-L1 combined positive score >= 1. These approvals marked the first new therapies for these patients since 2006, as well as the first immunotherapeutic approvals in this disease. In light of the introduction of these novel therapies for the treatment of patients with head and neck cancer, The Society for Immunotherapy of Cancer (SITC) formed an expert committee tasked with generating consensus recommendations for emerging immunotherapies, including appropriate patient selection, therapy sequence, response monitoring, adverse event management, and biomarker testing. These consensus guidelines serve as a foundation to assist clinicians' understanding of the role of immunotherapies in this disease setting, and to standardize utilization across the field for patient benefit. Due to country-specific variances in approvals, availability and regulations regarding the discussed agents, this panel focused solely on FDA-approved drugs for the treatment of patients in the U.S.