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Title: Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation

Abstract

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 datamore » collection methods.« less

Authors:
 [1];  [2];  [3];  [4];  [5];  [6];  [7];  [8];  [9];  [10]
  1. Department of Radiation Oncology, James P. Wilmot Cancer Center, University of Rochester School of Medicine and Dentistry, Rochester, NY (United States). E-mail: Yuhchyau_chen@urmc.rochester.edu
  2. Division of Radiation Oncology, H. Lee Moffitt Cancer Center, University of South Florida, Tampa, FL (United States)
  3. Radiation Oncology Sciences Program, National Cancer Institute, Bethesda, MD (United States)
  4. Radiation Oncology at Thomas Jefferson University Hospital, Philadelphia, PA, and Radiation Therapy Oncology Group (United States)
  5. Centre Hospitalier Universitaire, Vaudois, Lausanne (Switzerland) and European Organization for Research and Treatment of Cancer, Brussels (Belgium)
  6. British Columbia Cancer Agency, Vancouver (Canada) and National Cancer Institute of Canada Clinical Trials Group, Toronto, Ontario (Canada)
  7. Department of Radiation Oncology, Newcastle Mater Hospital, and Trans-Tasman Radiation Oncology Group, Newcastle, New South Wales (Australia)
  8. National Institut of Oncology, Rabat (Morocco) and African Radiation Oncology Group, Cape Town (South Africa)
  9. Hospital do Cancer-A.C. Camargo, Sao Paulo (Brazil) and Curriculo Radioterapeutica Ibero Latino Americana, Lima (Peru)
  10. Applied Radiation Biology and Radiotherapy Section, International Atomic Energy Agency, Vienna (Austria)
Publication Date:
OSTI Identifier:
20793430
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 64; Journal Issue: 5; Other Information: DOI: 10.1016/j.ijrobp.2005.10.014; PII: S0360-3016(05)02818-X; Copyright (c) 2006 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; BIOLOGICAL MARKERS; CLINICAL TRIALS; IAEA; IMPLEMENTATION; MEETINGS; NEOPLASMS; PUBLIC HEALTH; RADIATION INJURIES; RADIOBIOLOGY; RADIOTHERAPY; TOXICITY

Citation Formats

Chen Yuhchyau, Trotti, Andy, Coleman, C. Norman, Machtay, Mitchell, Mirimanoff, Rene O., Hay, John, O'Brien, Peter C., El-Gueddari, Brahim, Salvajoli, Joao V., and Jeremic, Branislav. Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation. United States: N. p., 2006. Web. doi:10.1016/J.IJROBP.2005.1.
Chen Yuhchyau, Trotti, Andy, Coleman, C. Norman, Machtay, Mitchell, Mirimanoff, Rene O., Hay, John, O'Brien, Peter C., El-Gueddari, Brahim, Salvajoli, Joao V., & Jeremic, Branislav. Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation. United States. doi:10.1016/J.IJROBP.2005.1.
Chen Yuhchyau, Trotti, Andy, Coleman, C. Norman, Machtay, Mitchell, Mirimanoff, Rene O., Hay, John, O'Brien, Peter C., El-Gueddari, Brahim, Salvajoli, Joao V., and Jeremic, Branislav. 2006. "Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation". United States. doi:10.1016/J.IJROBP.2005.1.
@article{osti_20793430,
title = {Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation},
author = {Chen Yuhchyau and Trotti, Andy and Coleman, C. Norman and Machtay, Mitchell and Mirimanoff, Rene O. and Hay, John and O'Brien, Peter C. and El-Gueddari, Brahim and Salvajoli, Joao V. and Jeremic, Branislav},
abstractNote = {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.},
doi = {10.1016/J.IJROBP.2005.1},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 5,
volume = 64,
place = {United States},
year = 2006,
month = 4
}
  • Purpose: To report meetings of the Applied Radiation Biology and Radiotherapy section of the International Atomic Energy Agency (IAEA), organized to discuss issues surrounding, and develop initiatives to improve, the recording of adverse events (AE) in clinical trials. Methods and Materials: A first meeting was held in Atlanta, GA (October 2004). A second meeting was held in Denver, CO (October 2005) and focused on AE data capture. The National Cancer Institute Common Terminology Criteria for Adverse Events, version 3 (CTCAE) was suggested during the first meeting as the preferred common platform for the collection and reporting of AE data inmore » its clinical trials. The second meeting identified and reviewed the current weaknesses and variations in the capture of AE data, and proposals to improve the quality and consistency of data capture were discussed. Results: There is heterogeneity in the collection of AE data between both institutions and individual clinicians. The use of multiple scoring systems hampers comparisons of treatment outcomes between centers and trials. There is often insufficient detail on normal tissue treatment effects, which leads to an underestimate of toxicity. Implementation of improved data capture was suggested for one of the ongoing IAEA clinical trials. Conclusions: There is a need to compare the quality and completeness of data between institutions and the efficacy of structured/directed vs. traditional passive data collection. Data collection using the CTCAE (with or without a questionnaire) will be investigated in an IAEA multinational trial of radiochemotherapy and high-dose-rate brachytherapy in cervical cancer.« less
  • The ability to optimize treatments for cancer on the basis of relative risks for normal tissue injury has important implications in oncology, because higher doses of radiation might, in some diseases, improve both local control and survival. To achieve this goal, a thorough understanding of the molecular mechanisms responsible for radiation-induced toxicity will be essential. Recent research has demonstrated that ionizing radiation triggers a series of genetic and molecular events, which might lead to chronic persistent alterations in the microenvironment and an aberrant wound-healing response. Disrupted epithelial-stromal cell communication might also be important. With the application of a better understandingmore » of fundamental biology to clinical practice, new approaches to treating and preventing normal tissue injury can focus on correcting these disturbed molecular processes.« less
  • Iraq`s nuclear weapons development program used facilities and nuclear material separate from its safeguarded activities. To detect such a strategy the IAEA`s safeguards inspectors need access to locations and information beyond that foreseen in NPT safeguards agreements. But the IAEA is short of money. And detecting undeclared activities could be expensive. If the IAEA can establish a capability to detect undeclared activities, then it might be able to save on regular safeguards. But it`s important not to put the cart before the horse - effective safeguards must come first, savings second.
  • Purpose: To determine the incidence of pain flare after spine stereotactic body radiation therapy (SBRT) in steroid-naïve patients and identify predictive factors. Methods and Materials: Forty-one patients were treated with spine SBRT between February 2010 and April 2012. All patients had their pain assessed at baseline, during, and for 10 days after SBRT using the Brief Pain Inventory. All pain medications were recorded daily and narcotics converted to an oral morphine equivalent dose. Pain flare was defined as a 2-point increase in worst pain score as compared with baseline with no decrease in analgesic intake, a 25% increase in analgesicmore » intake as compared with baseline with no decrease in worst pain score, or if corticosteroids were initiated at any point during or after SBRT because of pain. Results: The median age and Karnofsky performance status were 57.5 years (range, 27-80 years) and 80 (range, 50-100), respectively. Eighteen patients were treated with 20-24 Gy in a single fraction, whereas 23 patients were treated with 24-35 Gy in 2-5 fractions. Pain flare was observed in 68.3% of patients (28 of 41), most commonly on day 1 after SBRT (29%, 8 of 28). Multivariate analysis identified a higher Karnofsky performance status (P=.02) and cervical (P=.049) or lumbar (P=.02) locations as significant predictors of pain flare. In those rescued with dexamethasone, a significant decrease in pain scores over time was subsequently observed (P<.0001). Conclusions: Pain flare is a common adverse event after spine SBRT and occurs most commonly the day after treatment completion. Patients should be appropriately consented for this adverse event.« less
  • Problems occurring with the radiation reaction of cells of different tissues during the division resting state are discussed and the importance of the mitotic cycle is pointed out. The problems mentioned are discussed with a dynamic -morphological approach. (P.C.H.)