Department of Medical Oncology and Head and Neck Surgery, Institut Roi Albert II, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale, Université catholique de Louvain, Brussels, Belgium.
European Organization for Research and Treatment of Cancer, Brussels, Belgium.
Eur J Cancer. 2018 Nov;104:219-223. doi: 10.1016/j.ejca.2018.07.315. Epub 2018 Oct 6.
Assessing tumour response using a traditional phase I, II and III trial approach is not without limitations, particularly when targeted therapies are involved. Window of opportunity trials, performed presurgically but differing from neoadjuvant studies, were developed in an attempt to overcome the limitations of the traditional approach. A recent window of opportunity trial, the EORTC 90111-24111-NOCI-HNCG study, evaluated afatinib in treatment-naive patients with squamous cell carcinoma of the head and neck. While this study was the first to demonstrate the activity of afatinib in this setting and to define its potential predictive biomarkers, it also highlighted the challenges associated with the window of opportunity trial design, including the impact of patient selection, tumour site, and other organisational issues. This report details the key learnings from the EORTC 90111-24111-NOCI-HNCG study and provides recommendations to overcome the challenges of this particular trial design.
使用传统的 I 期、II 期和 III 期试验方法评估肿瘤反应并非没有局限性，特别是在涉及靶向治疗时。机会之窗试验是在术前进行的，但与新辅助研究不同，旨在克服传统方法的局限性。最近的一项机会之窗试验，即 EORTC 90111-24111-NOCI-HNCG 研究，评估了阿法替尼在未经治疗的头颈部鳞状细胞癌患者中的应用。虽然这项研究首次证明了阿法替尼在这种情况下的活性，并确定了其潜在的预测生物标志物，但它也突出了机会之窗试验设计相关的挑战，包括患者选择、肿瘤部位和其他组织问题的影响。本报告详细介绍了 EORTC 90111-24111-NOCI-HNCG 研究的主要经验教训，并提出了克服这一特定试验设计挑战的建议。
