Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland.
Division of Medical Oncology, University of Colorado Cancer Center, Aurora, Colorado.
J Thorac Oncol. 2018 Dec;13(12):1818-1831. doi: 10.1016/j.jtho.2018.09.017. Epub 2018 Sep 27.
This Review Article provides a multi-stakeholder view on the current status of neoadjuvant therapy in lung cancer. Given the success of oncogene-targeted therapy and immunotherapy for patients with advanced lung cancer, there is a renewed interest in studying these agents in earlier disease settings with the opportunity to have an even greater impact on patient outcomes. There are unique opportunities and challenges with the neoadjuvant approach to drug development. To achieve more rapid knowledge turns, study designs, endpoints, and definitions of pathologic response should be standardized and harmonized. Continued dialogue with all stakeholders will be critical to design and test novel induction strategies, which could expedite drug development for patients with early lung cancer who are at high risk for metastatic recurrence.
这篇综述文章从多方利益相关者的角度探讨了肺癌新辅助治疗的现状。鉴于针对晚期肺癌患者的致癌基因靶向治疗和免疫治疗的成功,人们对在疾病早期阶段研究这些药物重新产生了兴趣,因为这有可能对患者的预后产生更大的影响。新辅助药物研发方法存在独特的机遇和挑战。为了更快地获得知识成果,研究设计、终点和病理反应的定义应标准化和协调一致。与所有利益相关者持续对话对于设计和测试新的诱导策略至关重要,这可能会加快高危转移性复发的早期肺癌患者的药物开发进程。