Decreasing the Adverse Effects of Cancer Therapy: National Cancer Institute Guidance for the Clinical Development of Radiation Injury Mitigators

Recently, many agents have been identified that target molecular pathways that can mitigate radiation toxicity. To date, no drugs have been approved as radiation injury mitigators, which are defined as agents administered after irradiation but before toxicity is manifest. In order to accelerate the...

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Bibliographic Details
Published in:Clinical cancer research 2011-01, Vol.17 (2), p.222-228
Main Authors: MOVSAS, Benjamin, VIKRAM, Bhadrasain, HAUER-JENSEN, Martin, MOULDER, John E, BASCH, Ethan, BROWN, Stephen L, KACHNIC, Lisa A, DICKER, Adam P, NORMAN COLEMAN, C, OKUNIEFF, Paul
Format: Article
Language:English
Subjects:
Algorithms
Antineoplastic agents
Biological and medical sciences
Clinical Trials as Topic
Drug Design
Humans
Medical sciences
Neoplasms - psychology
Neoplasms - radiotherapy
Pharmacology. Drug treatments
Quality of Life
Radiation Injuries - prevention & control
Radiotherapy - adverse effects
United States
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Summary:Recently, many agents have been identified that target molecular pathways that can mitigate radiation toxicity. To date, no drugs have been approved as radiation injury mitigators, which are defined as agents administered after irradiation but before toxicity is manifest. In order to accelerate the application of potential mitigators for cancer patients, a meeting sponsored by the National Cancer Institute (NCI) and National Institute of Allergy and Infectious Diseases (NIAID) was held in January 2010. This article presents an algorithm to guide clinical trials for such agents in patients receiving radiotherapy or radiochemotherapy. It reviews the mechanisms of radiation injury, the clinical problem, the preclinical and clinical development of candidate agents, and the design and conduct of clinical trials. The central role of patient reported outcomes is outlined, as well as key lessons learned from prior clinical trials. Ultimately, the goal is to be able to apply such promising agents to improve the quality of life for patients receiving radiotherapy or chemoradiotherapy for cancer.
ISSN:1078-0432
1557-3265
DOI:10.1158/1078-0432.ccr-10-1402