Clinical Development of Novel Drug-Radiotherapy Combinations
Clinical Development of Novel Drug-Radiotherapy Combinations
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DOI：
10.1158/1078-0432.ccr-18-2466
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发表时间：
2019-03-01
影响因子：
11.5
通讯作者：
Sharma, Ricky A.
中科院分区：
文献类型：
--
作者：
Ahmad, Saif S.;Crittenden, Marka R.;Sharma, Ricky A.
放射治疗是大多数癌症患者治疗的基本组成部分。近几十年来，技术进步使患者能够接受更多针对肿瘤的放射剂量，而不影响邻近的正常组织。人们曾希望，精准医学时代将加强放射治疗与靶向抗癌药物的结合;然而，这一雄心仍有待实现。鉴于缺乏进展，FDA-AACR-ASTRO药物-放疗组合临床开发研讨会于2018年2月举行，汇集了来自学术界、临床放射肿瘤学、行业、患者倡导团体和FDA的利益相关者和意见领袖，讨论将新的药物-放疗组合引入临床的挑战。这篇监管科学与政策的观点文章总结了讨论的主题和行动点。需要智能试验设计来增加有效满足其主要结局的研究数量;要考虑的终点包括局部控制、器官保存和患者报告的结局。新的方法，包括免疫肿瘤学或DNA修复抑制剂与放射治疗相结合，应优先考虑。在这篇文章中，我们专注于如何克服与定义新的药物-放疗组合相关的监管挑战，以改善癌症患者的临床结局。
Radiotherapy is a fundamental component of treatment for the majority of patients with cancer. In recent decades, technological advances have enabled patients to receive more targeted doses of radiation to the tumor, with sparing of adjacent normal tissues. There had been hope that the era of precision medicine would enhance the combination of radiotherapy with targeted anticancer drugs; however, this ambition remains to be realized. In view of this lack of progress, the FDA-AACR-ASTRO Clinical Development of Drug-Radiotherapy Combinations Workshop was held in February 2018 to bring together stakeholders and opinion leaders from academia, clinical radiation oncology, industry, patient advocacy groups, and the FDA to discuss challenges to introducing new drug-radiotherapy combinations to the clinic. This Perspectives in Regulatory Science and Policy article summarizes the themes and action points that were discussed. Intelligent trial design is required to increase the number of studies that efficiently meet their primary outcomes; endpoints to be considered include local control, organ preservation, and patient-reported outcomes. Novel approaches including immune-oncology or DNA-repair inhibitor agents combined with radiotherapy should be prioritized. In this article, we focus on how the regulatory challenges associated with defining a new drug-radiotherapy combination can be overcome to improve clinical outcomes for patients with cancer.