Rivera Fernando, García-Castaño Almudena, Vega Noelia, Vega-Villegas Maria Eugenia, Gutiérrez-Sanz Lourdes
Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, 39008 Santander, Spain.
Expert Rev Anticancer Ther. 2009 Oct;9(10):1421-8. doi: 10.1586/era.09.113.
Expression of EGF receptor (EGFR) is frequently elevated in squamous cell carcinoma of the head and neck (SCCHN). Cetuximab is an anti-EGFR monoclonal antibody that has been shown to improve overall survival in patients with locally advanced SCCHN when combined with radiotherapy. Data from Phase II trials suggest an interesting activity of cetuximab in patients with recurrent or metastatic SCCHN who are refractory to cisplatin. The Erbitux in First-Line Treatment of Recurrent or Metastatic Head and Neck Cancer (EXTREME) Phase III trial compared platin-5-fluorouracil alone versus combined with cetuximab as first-line treatment in recurrent or metastatic SCCHN. In the cetuximab arm of this study, a significant improvement in the overall survival (the main objective), progression-free survival and response rate were observed. The quality of life analyses (QLQ-C30 and QLQ-H&N35) showed no significant differences in most of the studied scores between the two treatment arms. Nevertheless, patients in the cetuximab arm displayed significant improvements in pain, swallowing problems and scores for speech and social eating problems. The results of the EXTREME study (and other studies evaluating cetuximab for the treatment of SCCHN) suggest a lack of a predictive value for the expression of EGFR (determined by immunohistochemistry) by the tumor and other biomarkers need to be investigated. The role of other targeted drugs and of possible combinations of these new drugs with cetuximab should be investigated in properly designed preclinical studies and clinical trials.
表皮生长因子受体（EGFR）在头颈部鳞状细胞癌（SCCHN）中表达常常升高。西妥昔单抗是一种抗EGFR单克隆抗体，已证明与放疗联合使用时可提高局部晚期SCCHN患者的总生存率。II期试验数据表明，西妥昔单抗对顺铂难治的复发或转移性SCCHN患者具有有趣的活性。复发性或转移性头颈癌一线治疗中的爱必妥（EXTREME）III期试验比较了单独使用铂-5-氟尿嘧啶与联合西妥昔单抗作为复发性或转移性SCCHN的一线治疗。在本研究的西妥昔单抗组中，观察到总生存率（主要目标）、无进展生存率和缓解率有显著改善。生活质量分析（QLQ-C30和QLQ-H&N35）显示，两个治疗组之间大多数研究得分无显著差异。然而，西妥昔单抗组的患者在疼痛、吞咽问题以及言语和社交进食问题得分方面有显著改善。EXTREME研究（以及其他评估西妥昔单抗治疗SCCHN的研究）结果表明，肿瘤EGFR表达（通过免疫组织化学测定）缺乏预测价值，需要研究其他生物标志物。应在设计合理的临床前研究和临床试验中研究其他靶向药物的作用以及这些新药与西妥昔单抗联合使用的可能性。
