Faculty Collaboration Database

Decreasing the adverse effects of cancer therapy: National Cancer Institute guidance for the clinical development of radiation injury mitigators. Clin Cancer Res 2011 Jan 15;17(2):222-8

Date

11/05/2010

Pubmed ID

21047979

DOI

10.1158/1078-0432.CCR-10-1402

Scopus ID

2-s2.0-79251515199 (requires institutional sign-in at Scopus site)   27 Citations

Abstract

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.

Author List

Movsas B, Vikram B, Hauer-Jensen M, Moulder JE, Basch E, Brown SL, Kachnic LA, Dicker AP, Coleman CN, Okunieff P

MESH terms used to index this publication - Major topics in bold

Algorithms
Clinical Trials as Topic
Drug Design
Humans
Neoplasms
Quality of Life
Radiation Injuries
Radiotherapy
United States