Offin Michael, Liu Dazhi, Drilon Alexander
From the Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY; Department of Pharmacy, Memorial Sloan Kettering Cancer Center, New York, NY.
Am Soc Clin Oncol Educ Book. 2018 May 23;38:184-187. doi: 10.1200/EDBK_200831.
Therapies designed to target cancers that harbor specific molecular signatures have reshaped the landscape of oncologic drug development, and advances in next generation sequencing have led to an increase in the identification of these alterations across tumor types. Tumor-agnostic trial designs, such as the "basket trial," have been developed as an approach to study the efficacy of these treatments and increase patient access, especially for patients whose tumors carry these alterations infrequently. We review key aspects of these genomically enriched trial strategies and their impact on drug development and approval.
旨在针对具有特定分子特征的癌症的疗法重塑了肿瘤学药物研发的格局,而新一代测序技术的进步使得跨肿瘤类型识别这些改变的能力有所提高。诸如“篮子试验”之类的与肿瘤无关的试验设计已被开发出来,作为研究这些治疗方法疗效并增加患者获得治疗机会的一种途径,特别是对于那些肿瘤中这些改变很少见的患者。我们回顾了这些基因组富集试验策略的关键方面及其对药物研发和批准的影响。