Moores Cancer Center, University of California San Diego, San Diego, CA, USA.
Earle A. Chiles Research Institute at the Robert W. Franz Cancer Center, Providence Cancer Institute, Portland, OR, USA.
J Immunother Cancer. 2019 Jul 15;7(1):184. doi: 10.1186/s40425-019-0662-5.
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.
头颈部癌症,包括唇和口腔、鼻腔、副鼻窦、口咽、喉和鼻咽的癌症,每年在全球造成近 70 万新发病例和 38 万例死亡,仅在美国就有超过 1 万人每年因此死亡。需要改善复发性和/或转移性头颈部鳞状细胞癌(HNSCC)患者的治疗效果。2016 年,美国食品和药物管理局(FDA)首次批准了免疫治疗药物——抗 PD-1 免疫检查点抑制剂纳武利尤单抗和帕博利珠单抗,用于治疗铂类方案耐药的复发性头颈部鳞状细胞癌(HNSCC)患者。2017 年,欧洲委员会紧随其后批准纳武利尤单抗用于治疗相同的患者群体,此后不久又批准帕博利珠单抗单药治疗肿瘤 PD-L1 表达阳性(肿瘤比例评分≥50%)且在含铂化疗后进展的复发性或转移性 HNSCC 成年患者。然后在 2019 年,FDA 批准 PD-1 抑制作为转移性或不可切除、复发性 HNSCC 患者的一线治疗,批准帕博利珠单抗联合铂类和氟尿嘧啶用于所有 HNSCC 患者,以及帕博利珠单抗单药用于肿瘤 PD-L1 联合阳性评分≥1 的 HNSCC 患者。这些批准标志着自 2006 年以来这些患者的首次新疗法,也是该疾病的首次免疫治疗批准。鉴于这些新型疗法用于治疗头颈部癌症患者,癌症免疫治疗学会(SITC)成立了一个专家委员会,负责制定新兴免疫疗法的共识建议,包括适当的患者选择、治疗顺序、反应监测、不良事件管理和生物标志物检测。这些共识指南为协助临床医生了解免疫疗法在这一疾病背景下的作用,并为患者利益在整个领域内标准化利用提供了基础。由于各国对所讨论药物的批准、供应和监管存在差异,该小组仅关注美国治疗患者的 FDA 批准药物。
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