TY - JOUR
T1 - Adverse event reporting and developments in radiation biology after normal tissue injury
T2 - International Atomic Energy Agency consultation
AU - Chen, Yuhchyau
AU - Trotti, Andy
AU - Coleman, C. Norman
AU - MacHtay, Mitchell
AU - Mirimanoff, Rene O.
AU - Hay, John
AU - O'Brien, Peter C.
AU - El-Gueddari, Brahim
AU - Salvajoli, Joao V.
AU - Jeremic, Branislav
N1 - Funding Information:
In general, the effects of radiation on humans have been studied by three groups of researchers. The first group investigates the environmental impact of chronic, low-dose radiation lower than 1 Gy. These studies have been supported by the National Institutes of Health, Department of Energy, and National Aeronautics and Space Administration. The second group studies high-dose, single-dose, or fractionated radiation in the range generally higher than 10 Gy and up to 100 Gy. These studies have been performed by the radiation oncology and biology communities supported by the National Cancer Institute and other funding agencies. Single-dose exposure, as may occur in a nuclear attack or accident, has been of interest to the Department of Defense and the Armed Forces Radiobiology Research Institute. The terrorist attack in New York City and the Pentagon on Sept 11, 2001, heightened concern regarding radiologic/nuclear terrorism via an improvised nuclear device, a dirty bomb, or environmental contamination with radioisotopes for radiation researchers and pertinent government agencies. Research in this scenario deals with a radiation dose range of 1–10 Gy, which was termed moderate-dose radiation ( 13 ). Furthermore, with the recent implementation of intensity-modulated radiotherapy, moderate-dose radiation is increasingly relevant to clinical radiation therapy for cancer. The ability to focus and shape the radiation through multibeam, multiplanar, and arc beams has led to more tissues receiving low or moderate radiation doses, compared with the more conventional, three-dimensional conformal approaches. Relevant observations on the limitations of intensity-modulated radiotherapy include that it may produce a significantly higher whole-body dose ( 19 ), and that, although the incidence of radiation inducible cancer is low (approximately 1%), intensity-modulated radiotherapy may lead to a doubling of radiation-induced cancers ( 20 ). Indeed, secondary cancers tend to occur at the margins of the field (approximately 6 Gy) ( 21 ). The consequences of large-volume, moderate-dose radiation normal tissue exposure, via treatment or accident, needs to be closely studied and monitored.
PY - 2006/4/1
Y1 - 2006/4/1
N2 - Purpose: Recent research has enhanced our understanding of radiation injury at the molecular-cellular and tissue levels; significant strides have occurred in standardization of adverse event reporting in clinical trials. In response, the International Atomic Energy Agency, through its Division of Human Health and its section for Applied Radiation Biology and Radiotherapy, organized a consultation meeting in Atlanta (October 2, 2004) to discuss developments in radiobiology, normal tissue reactions, and adverse event reporting. Methods and Materials: Representatives from cooperative groups of African Radiation Oncology Group, Curriculo Radioterapeutica Ibero Latino Americana, European Organization for Research and Treatment of Cancer, National Cancer Institute of Canada Clinical Trials Group, Radiation Therapy Oncology Group, and Trans-Tasman Radiation Oncology Group held the meeting discussion. Results: Representatives of major radiotherapy groups/organizations and prominent leaders in radiotherapy discussed current understanding of normal tissue radiobiologic effects, the design and implementation of future clinical and translational projects for normal tissue injury, and the standardization of adverse-event reporting worldwide. Conclusions: The consensus was to adopt NCI comprehensive adverse event reporting terminology and grading system (CTCAE v3.0) as the new standard for all cooperative group trials. Future plans included the implementation of coordinated research projects focusing on normal tissue biomarkers and data collection methods.
AB - Purpose: Recent research has enhanced our understanding of radiation injury at the molecular-cellular and tissue levels; significant strides have occurred in standardization of adverse event reporting in clinical trials. In response, the International Atomic Energy Agency, through its Division of Human Health and its section for Applied Radiation Biology and Radiotherapy, organized a consultation meeting in Atlanta (October 2, 2004) to discuss developments in radiobiology, normal tissue reactions, and adverse event reporting. Methods and Materials: Representatives from cooperative groups of African Radiation Oncology Group, Curriculo Radioterapeutica Ibero Latino Americana, European Organization for Research and Treatment of Cancer, National Cancer Institute of Canada Clinical Trials Group, Radiation Therapy Oncology Group, and Trans-Tasman Radiation Oncology Group held the meeting discussion. Results: Representatives of major radiotherapy groups/organizations and prominent leaders in radiotherapy discussed current understanding of normal tissue radiobiologic effects, the design and implementation of future clinical and translational projects for normal tissue injury, and the standardization of adverse-event reporting worldwide. Conclusions: The consensus was to adopt NCI comprehensive adverse event reporting terminology and grading system (CTCAE v3.0) as the new standard for all cooperative group trials. Future plans included the implementation of coordinated research projects focusing on normal tissue biomarkers and data collection methods.
UR - http://www.scopus.com/inward/record.url?scp=33645359996&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33645359996&partnerID=8YFLogxK
U2 - 10.1016/j.ijrobp.2005.10.014
DO - 10.1016/j.ijrobp.2005.10.014
M3 - Article
C2 - 16414207
AN - SCOPUS:33645359996
SN - 0360-3016
VL - 64
SP - 1442
EP - 1451
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 5
ER -
