Yanagihara TK, Tepper JE, Moon AM, Barry A, Molla M, Seong J, Torres F, Apisarnthanarax S, Buckstein M, Cardenes H, Chang DT, Feng M, Guha C, Hallemeier CL, Hawkins MA, Hoyer M, Iwata H, Jabbour SK, Kachnic L, Kharofa J, Kim TH, Kirichenko A, Koay EJ, Makishima H, Mases J, Meyer JJ, Munoz-Schuffenegger P, Owen D, Park HC, Saez J, Sanford NN, Scorsetti M, Smith GL, Wo JY, Yoon SM, Lawrence TS, Reig M, and Dawson LA
Purpose: External beam radiation therapy (EBRT) is a highly effective treatment in select patients with hepatocellular carcinoma (HCC). However, the Barcelona Clinic Liver Cancer system does not recommend the use of EBRT in HCC due to a lack of sufficient evidence and intends to perform an individual patient level meta-analysis of ablative EBRT in this population. However, there are many types of EBRT described in the literature with no formal definition of what constitutes "ablative." Thus, we convened a group of international experts to provide consensus on the parameters that define ablative EBRT in HCC., Methods and Materials: Fundamental parameters related to dose, fractionation, radiobiology, target identification, and delivery technique were identified by a steering committee to generate 7 Key Criteria (KC) that would define ablative EBRT for HCC. Using a modified Delphi (mDelphi) method, experts in the use of EBRT in the treatment of HCC were surveyed. Respondents were given 30 days to respond in round 1 of the mDelphi and 14 days to respond in round 2. A threshold of ≥70% was used to define consensus for answers to each KC., Results: Of 40 invitations extended, 35 (88%) returned responses. In the first round, 3 of 7 KC reached consensus. In the second round, 100% returned responses and consensus was reached in 3 of the remaining 4 KC. The distribution of answers for one KC, which queried the a/b ratio of HCC, was such that consensus was not achieved. Based on this analysis, ablative EBRT for HCC was defined as a BED10 ≥80 Gy with daily imaging and multiphasic contrast used for target delineation. Treatment breaks (eg, for adaptive EBRT) are allowed, but the total treatment time should be ≤6 weeks. Equivalent dose when treating with protons should use a conversion factor of 1.1, but there is no single conversion factor for carbon ions., Conclusions: Using a mDelphi method assessing expert opinion, we provide the first consensus definition of ablative EBRT for HCC. Empirical data are required to define the a/b of HCC., Competing Interests: Disclosures Ted K. Yanagihara reports grants or contracts from the Radiation Oncology Institute and Lineberger Comprehensive Cancer Center; serving as an expert independent reviewer for the North Carolina Medical Board; and serving as an American Board of Radiology Maintenance of Certification online longitudinal assessment senior reviewer. Andrew M. Moon reports grants or contracts from the American Association for the Study of Liver Diseases, the American College of Gastroenterology, and the National Institutes of Health; consulting feeds from Target RWE; and serving on the American Association for the Study of Liver Diseases Practice Guidelines Committee. Aisling Barry reports honoria from Eisai. Ferran Torres reports grants or contracts from the Hospital Clinic Barcelona (IDIBAPS); consulting fees from Universal DX; and participation in the data safety monitoring board/advisory board of the Hospital Clinic Barcelona with partial support from Bayer. Daniel T. Chang reports grants or contracts from RefleXion Medical, ViewRay, Inc, Varian Medical Systems; honoraria for presentation from Varian Medical Systems; support for attending meetings and travel from Varian Medical Systems; and participation on data safety monitoring board for the SMART trial for ViewRay. Chandan Guha reports grants or contracts from the NIH, Janssen and Celldex; consulting fees from Janssen; participation in the data safety monitoring board or advisory board of the Focused Ultrasound Foundation; and is a founder of BioConvergent Health. Morten Hoyer reports honoraria from Novo Nordisk. Lisa Kachnic reports receiving grants or contracts from Varian Medical Systems; serving as an editor for UpToDate; participation on the data safety monitoring committee for Beta Innovations; and is a board member of the Radiation Therapy Oncology Group. Eugene J. Koay reports funding from the Department of Defense and National Institutes of Health; grants or contracts from Philips Healthcare, GE Healthcare, Stand up to Cancer, Project Purple, Elekta, Department of Defense; royalties from Taylor and Francis, LLC; consulting fees from RenovoRx, AstraZeneca, Augmenix, and Kallisio; honoraria for lectures from Apollo Cancer hospitals in Chnnai India, Bayer Healthcare, Philips Healthcare, and Aptitude Health; a patent pending for 3-dimensional printed oral stents; serving on the scientific medical advisory board of the International Cholangiocarcinoma Research Network; and stock ownership of Quantum Aurea Capital. Joel Mases reports grants or contracts from Boston Scientific and royalties or licenses from Springer and UpToDate. Pablo Munoz-Schuffenegger reports grants or contracts from the National Fund for Scientific and Technological Development, National Commission for Scientific and Technological Research, Government of Chile; honoraria for lectures from Bayer and Roche Pharma AG; serving on an advisory board for AstraZeneca; and serving on the advanced radiation therapy committee, International Association for the Study of Lung Cancer. Dawn Owen reports payment from UpToDate and receipt of goods/services from AstraZeneca and Varian Medical Systems. Marta Scorsetti reports grants or contracts from Varian Medical Systems, Sofar, and IPSEN. Jenniefer Y. Wo reports grants or contracts from Genentech. Maria Reig reports grants or contracts from Bayer, Ipsen, and ISCII; serving as a consultant or on advisory boards and/or receiving travel support from Bayer, BMS, Roche, Ipsen, AstraZeneca, Eisai, Geneos Therapeutics, UniveralDx, MSD and Lilly; receiving lecture fees from Bayer, BMS, Gilead, AstraZeneca, ROCHE and Lilly; receiving support for attending meetings and/or travel from Bayer, BMS, Roche, Ipsen, AstraZeneca, Eisai, MSD, and Lilly; and serving as EASL representative in UEG. Laura A. Dawson reports serving as chair of ASTRO., (Copyright © 2023. Published by Elsevier Inc.)