Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation.
OBJECTIVE
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
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.
Chen
Yuhchyau
Y
Department of Radiation Oncology, James P. Wilmot Cancer Center, University of Rochester School of Medicine and Dentistry, Rochester, NY 14642-8647, USA. Yuhchyau_chen@urmc.rochester.edu
Trotti
Andy
A
Coleman
C Norman
CN
Machtay
Mitchell
M
Mirimanoff
Rene O
RO
Hay
John
J
O'brien
Peter C
PC
El-Gueddari
Brahim
B
Salvajoli
Joao V
JV
Jeremic
Branislav
B
D015415:Biomarkers / Q000032:analysis; D004249:DNA Damage; D004014:Dictionaries as Topic; D006801:Humans; D007390:International Agencies / Q000592:standards*; D009369:Neoplasms / Q000532:radiotherapy*; D009678:Nuclear Energy; D011183:Postoperative Complications; D011832:Radiation Injuries / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D018787:Radiation Oncology / Q000458:organization & administration / Q000592:standards; D011837:Radiation-Protective Agents / Q000627:therapeutic use; D011853:Radiobiology / Q000592:standards*; D011879:Radiotherapy Dosage; D012720:Severity of Illness Index; D009626:Terminology as Topic
D015415:Biomarkers; D011837:Radiation-Protective Agents