TY - JOUR
T1 - Decreasing the adverse effects of cancer therapy
T2 - National cancer institute guidance for the clinical development of radiation injury mitigators
AU - Movsas, Benjamin
AU - Vikram, Bhadrasain
AU - Hauer-Jensen, Martin
AU - Moulder, John E.
AU - Basch, Ethan
AU - Brown, Stephen L.
AU - Kachnic, Lisa A.
AU - Dicker, Adam P.
AU - Coleman, C. Norman
AU - Okunieff, Paul
PY - 2011/1/15
Y1 - 2011/1/15
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=79251515199&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79251515199&partnerID=8YFLogxK
U2 - 10.1158/1078-0432.CCR-10-1402
DO - 10.1158/1078-0432.CCR-10-1402
M3 - Review article
C2 - 21047979
AN - SCOPUS:79251515199
SN - 1078-0432
VL - 17
SP - 222
EP - 228
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 2
ER -