Division of Cancer Treatment and Diagnosis, NCI, Bethesda, Maryland.
SWOG Cancer Research Network, OHSU Knight Cancer Center, Portland, Oregon.
Clin Cancer Res. 2023 Dec 1;29(23):4728-4732. doi: 10.1158/1078-0432.CCR-23-0917.
Basket, umbrella, and platform trial designs (master protocols) have emerged over the last decade to study precision medicine approaches in oncology. First-generation trials like NCI-MATCH (Molecular Analysis for Therapy Choice) have proven the principle that studying targeted therapies on a large scale is feasible both from the laboratory and clinical perspectives. However, single-agent targeted therapies have shown limited ability to control metastatic disease, despite careful matching of drug to target. As such, newer approaches employing combinations of targeted therapy, or targeted therapy with standard therapies, need to be considered. The NCI has recently embarked on three second-generation precision medicine trials to address this need: ComboMATCH, iMATCH, and myeloMATCH. The design of these trials and necessary infrastructure are discussed in the following perspective.
篮子、伞和平台试验设计（主方案）在过去十年中出现，用于研究肿瘤学中的精准医学方法。像 NCI-MATCH（治疗选择的分子分析）这样的第一代试验已经证明了从实验室和临床角度来看，大规模研究靶向治疗是可行的原则。然而，尽管药物与靶点的匹配非常仔细，但单一的靶向治疗药物在控制转移性疾病方面的能力有限。因此，需要考虑采用靶向治疗联合或靶向治疗联合标准治疗的新方法。NCI 最近开展了三项第二代精准医学试验来满足这一需求：ComboMATCH、iMATCH 和 myeloMATCH。以下是对这些试验的设计和必要基础设施的讨论。
