Repository logo
 

Clinical Development of Novel Drug-Radiotherapy Combinations.

Accepted version
Peer-reviewed

Type

Article

Change log

Authors

Ahmad, Saif S 
Crittenden, Marka R 
Tran, Phuoc T 
Kluetz, Paul G 
Blumenthal, Gideon M 

Abstract

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.

Description

Keywords

Animals, Chemoradiotherapy, Clinical Trials as Topic, Combined Modality Therapy, Disease Management, Disease Progression, Humans, Neoplasms, Research Design, Treatment Outcome

Journal Title

Clin Cancer Res

Conference Name

Journal ISSN

1078-0432
1557-3265

Volume Title

25

Publisher

American Association for Cancer Research (AACR)
Sponsorship
Cancer Research UK (C48525/A16679)
Cancer Research UK (C9685/A20760)