Radiation Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, Maryland 20892.
National Institutes of Health Library, Office of Research Services, Office of the Director, National Institutes of Health, Bethesda, Maryland 20892.
Radiat Res. 2022 Dec 1;198(6):625-631. doi: 10.1667/RADE-22-00077.1.
Preclinical studies inform and guide the development of novel treatment combination strategies that bridge the laboratory with the clinic. We aimed to evaluate approaches cancer researchers used to justify advancing new combinations of molecularly targeted agents and radiation treatment into early-phase human clinical trials. Unsolicited early phase clinical trial proposals submitted to the National Cancer Institute's Cancer Therapy Evaluation Program between January 2016 and July 2020 were curated to quantify key characteristics and proportion of preclinical data provided by trialists seeking to conduct molecularly targeted agent-radiation combination studies in cancer patients. These data elucidate the current landscape for how the rationale for a molecularly targeted agent-radiation combination therapy is supported by preclinical research and illustrate unique challenges faced in translation at the intersection of precision medicine and radiation oncology.
临床前研究为新型治疗联合策略的发展提供信息和指导，将实验室与临床联系起来。我们旨在评估癌症研究人员用于将新型分子靶向药物和放射治疗联合应用于早期人体临床试验的方法。本研究对 2016 年 1 月至 2020 年 7 月期间向美国国家癌症研究所癌症治疗评估计划提交的非邀约性早期临床试验提案进行了整理，以量化寻求在癌症患者中开展分子靶向药物-放射联合研究的试验人员提供的关键特征和临床前数据的比例。这些数据阐明了当前如何通过临床前研究支持分子靶向药物-放射联合治疗的基本原理，并说明了在精准医学和放射肿瘤学交叉点进行转化所面临的独特挑战。
