PURPOSE: Standardized response criteria are needed to interpret and compare clinical trials and for approval of new therapeutic agents by regulatory agencies. METHODS: The International Working Group response criteria (Cheson et al, J Clin Oncol 17:1244, 1999) were widely adopted, but required reassessment because of identified limitations and the increased use of [18F]fluorodeoxyglucose-positron emission tomography (PET), immunohistochemistry (IHC), and flow cytometry. The International Harmonization Project was convened to provide updated recommendations. RESULTS: New guidelines are presented incorporating PET, IHC, and flow cytometry for definitions of response in non-Hodgkin's and Hodgkin's lymphoma. Standardized definitions of end points are provided. CONCLUSION: We hope that these guidelines will be adopted widely by study groups, pharmaceutical and biotechnology companies, and regulatory agencies to facilitate the development of new and more effective therapies to improve the outcome of patients with lymphoma.
PURPOSE: Standardized response criteria are needed to interpret and compare clinical trials and for approval of new therapeutic agents by regulatory agencies. METHODS: The International Working Group response criteria (Cheson et al, J Clin Oncol 17:1244, 1999) were widely adopted, but required reassessment because of identified limitations and the increased use of [18F]fluorodeoxyglucose-positron emission tomography (PET), immunohistochemistry (IHC), and flow cytometry. The International Harmonization Project was convened to provide updated recommendations. RESULTS: New guidelines are presented incorporating PET, IHC, and flow cytometry for definitions of response in non-Hodgkin's and Hodgkin's lymphoma. Standardized definitions of end points are provided. CONCLUSION: We hope that these guidelines will be adopted widely by study groups, pharmaceutical and biotechnology companies, and regulatory agencies to facilitate the development of new and more effective therapies to improve the outcome of patients with lymphoma.
Authors: James N Kochenderfer; Mark E Dudley; Steven A Feldman; Wyndham H Wilson; David E Spaner; Irina Maric; Maryalice Stetler-Stevenson; Giao Q Phan; Marybeth S Hughes; Richard M Sherry; James C Yang; Udai S Kammula; Laura Devillier; Robert Carpenter; Debbie-Ann N Nathan; Richard A Morgan; Carolyn Laurencot; Steven A Rosenberg Journal: Blood Date: 2011-12-08 Impact factor: 22.113
Authors: Todd A Fehniger; Sarah Larson; Kathryn Trinkaus; Marilyn J Siegel; Amanda F Cashen; Kristie A Blum; Timothy S Fenske; David D Hurd; Andre Goy; Stephanie E Schneider; Catherine R Keppel; Nina D Wagner-Johnston; Kenneth R Carson; Nancy L Bartlett Journal: Blood Date: 2011-09-21 Impact factor: 22.113
Authors: Sarah C Rutherford; Michael Herold; Wolfgang Hiddemann; Lale Kostakoglu; Robert Marcus; Maurizio Martelli; Laurie H Sehn; Marek Trněný; Judith Trotman; Umberto Vitolo; Tina Nielsen; Federico Mattiello; Deniz Sahin; Gila Sellam; Peter Martin Journal: Blood Adv Date: 2020-04-28
Authors: Mehdi Hamadani; Wael Saber; Kwang Woo Ahn; Jeanette Carreras; Mitchell S Cairo; Timothy S Fenske; Robert Peter Gale; John Gibson; Gregory A Hale; Parameswaran N Hari; Jack W Hsu; David J Inwards; Rammurti T Kamble; Anderas Klein; Dipnarine Maharaj; David I Marks; David A Rizzieri; Bipin N Savani; Harry C Schouten; Edmund K Waller; Baldeep Wirk; Ginna G Laport; Silvia Montoto; David G Maloney; Hillard M Lazarus Journal: Biol Blood Marrow Transplant Date: 2013-02-01 Impact factor: 5.742
Authors: Margaretha G M Roemer; Robert A Redd; Fathima Zumla Cader; Christine J Pak; Sara Abdelrahman; Jing Ouyang; Stephanie Sasse; Anas Younes; Michelle Fanale; Armando Santoro; Pier Luigi Zinzani; John Timmerman; Graham P Collins; Radhakrishnan Ramchandren; Jonathon B Cohen; Jan Paul De Boer; John Kuruvilla; Kerry J Savage; Marek Trneny; Stephen Ansell; Kazunobu Kato; Benedetto Farsaci; Anne Sumbul; Philippe Armand; Donna S Neuberg; Geraldine S Pinkus; Azra H Ligon; Scott J Rodig; Margaret A Shipp Journal: J Clin Oncol Date: 2018-02-02 Impact factor: 44.544