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Journal of Clinical Oncology, Vol 17, Issue 4 (April), 1999: 1244
© 1999 American Society for Clinical Oncology

Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas

Bruce D. Cheson, Sandra J. Horning, Bertr Coiffier, Margaret A. Shipp, Richard I. Fisher, Joseph M. Connors, T. Andrew Lister, Julie Vose, Antonio Grillo-López, Anton Hagenbeek, Fernando Cabanillas, Donald Klippensten, Wolfgang Hiddemann, Ronald Castellino, Nancy L. Harris, James O. Armitage, William Carter, Richard Hoppe, George P. Canellos

From the National Cancer Institute, Bethesda, MD; Stanford University, Palo Alto, CA; Centre Hospitalier Lyon-Sud, Lyon, France; Dana-Farber Cancer Institute, Boston, MA; Loyola University, Maywood, IL; British Columbia Cancer Agency, Vancouver, British Columbia, Canada; St. Bartholomew's Hospital, London, England; University of Nebraska, Omaha, NE; IDEC Corporation, San Diego, CA; Universiteit Utrecht, Utrecht, the Netherlands; M.D. Anderson Cancer Center, Houston, TX; Roswell Park Cancer Institute, Buffalo, NY; Klinikum Großhadern, Munich, Germany; Memorial Sloan-Kettering Cancer Center, New York, NY; Massachusetts General Hospital, Boston, MA; and Sharp Memorial Hospital, San Diego, CA.

Address reprint requests to Bruce D. Cheson, MD, National Cancer Institute, Executive Plaza North, Rm 741, Bethesda, MD 20892; email chesonb{at}ctep.nci.nih.gov

ABSTRACT: Standardized guidelines for response assessment are needed to ensure comparability among clinical trials in non-Hodgkin's lymphomas (NHL). To achieve this, two meetings were convened among United States and international lymphoma experts representing medical hematology/oncology, radiology, radiation oncology, and pathology to review currently used response definitions and to develop a uniform set of criteria for assessing response in clinical trials. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients—especially those with large-cell NHL—who may not have residual disease. Single-photon emission computed tomography gallium scans are encouraged as a valuable adjunct to assessment of patients with large-cell NHL, but such scans require appropriate expertise. Flow cytometric, cytogenetic, and molecular studies are not currently included in response definitions. Response rates may be the most important objective in phase II trials where the activity of a new agent is important and may provide support for approval by regulatory agencies. However, the goals of most phase III trials are to identify therapies that will prolong the progression-free survival, if not the overall survival, of the treated patients. We hope that these guidelines will serve to improve communication among investigators and comparability among clinical trials until clinically relevant laboratory and imaging studies are identified and become more widely available.




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A. M. Tsimberidou, S. Wen, S. O'Brien, P. McLaughlin, W. G. Wierda, A. Ferrajoli, S. Faderl, J. Manning, S. Lerner, C. V. Mai, et al.
Assessment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma by Absolute Lymphocyte Counts in 2,126 Patients: 20 Years of Experience at The University of Texas M.D. Anderson Cancer Center
J. Clin. Oncol., October 10, 2007; 25(29): 4648 - 4656.
[Abstract] [Full Text] [PDF]