Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.
Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.
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DOI：
10.3389/fonc.2017.00072
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发表时间：
2017
影响因子：
4.7
通讯作者：
Licitra L
中科院分区：
文献类型：
--
作者：
Argiris A;Harrington KJ;Tahara M;Schulten J;Chomette P;Ferreira Castro A;Licitra L
过去十年来，头颈部复发和/或转移性鳞状细胞癌（R/M SCCHN）一线治疗的主要发展是西妥昔单抗与铂+ 5-氟尿嘧啶化疗（CT）联合应用，随后是西妥昔单抗维持治疗（“EXTREME”方案）。该方案得到了一项3期随机试验和随后的观察性研究的支持，并提供了充分证明的生存益处，中位生存期约为10至14个月，总缓解率为36%至44%，疾病控制率超过80%。此外，根据患者报告的结果测量，在铂基CT上添加西妥昔单抗可以显著减少疼痛和社交饮食和语言问题。相反，直到最近，一直缺乏循证的二线治疗方案，现有的治疗方法显示出低反应率和较差的生存结果。目前，出现了一种很有希望的治疗R/M SCCHN的新选择：免疫检查点抑制剂（ICIs），它在二线临床试验中显示出良好的效果。Nivolumab和pembrolizumab是美国食品和药物管理局批准的前两种ICIs。我们注意到，显示ICIs有益的试验不仅包括先前接受过≥1种铂类药物治疗R/M SCCHN的患者，还包括局部晚期疾病联合铂类药物治疗后6个月内复发的患者。在这篇综述中，我们概述了EXTREME方案的现有临床和观察证据，以及用于R/M SCCHN患者的ICIs临床试验的初步结果。我们建议这些治疗方案可以整合到一个新的连续护理范例中，一线EXTREME方案之后是二线ICIs。许多正在进行的临床试验正在比较单独使用ICIs和与其他ICIs或CT联合使用的方案与EXTREME方案对R/M SCCHN一线治疗的影响。当我们急切地等待这些试验的结果时，EXTREME方案仍然是R/M SCCHN一线治疗的标准护理。
The major development of the past decade in the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) was the introduction of cetuximab in combination with platinum plus 5-fluorouracil chemotherapy (CT), followed by maintenance cetuximab (the “EXTREME” regimen). This regimen is supported by a phase 3 randomized trial and subsequent observational studies, and it confers well-documented survival benefits, with median survival ranging between approximately 10 and 14 months, overall response rates between 36 and 44%, and disease control rates of over 80%. Furthermore, as indicated by patient-reported outcome measures, the addition of cetuximab to platinum-based CT leads to a significant reduction in pain and problems with social eating and speech. Conversely, until very recently, there has been a lack of evidence-based second-line treatment options, and the therapies that have been available have shown low response rates and poor survival outcomes. Presently, a promising new treatment option in R/M SCCHN has emerged: immune checkpoint inhibitors (ICIs), which have demonstrated favorable results in second-line clinical trials. Nivolumab and pembrolizumab are the first two ICIs that were approved by the US Food and Drug Administration. We note that the trials that showed benefit with ICIs included not only patients who previously received ≥1 platinum-based regimens for R/M SCCHN but also patients who experienced recurrence within 6 months after combined modality therapy with a platinum agent for locally advanced disease. In this review, we outline the available clinical and observational evidence for the EXTREME regimen and the initial results from clinical trials for ICIs in patients with R/M SCCHN. We propose that these treatment options can be integrated into a new continuum of care paradigm, with first-line EXTREME regimen followed by second-line ICIs. A number of ongoing clinical trials are comparing regimens with ICIs, alone and in combination with other ICIs or CT, with the EXTREME regimen for first-line treatment of R/M SCCHN. As we eagerly await the results of these trials, the EXTREME regimen remains the standard of care for the first-line treatment of R/M SCCHN.