Revised Response Criteria for Malignant Lymphoma

TLDR

Standardized response criteria are essential for interpreting and comparing clinical trials and for regulatory approval, yet existing criteria were limited and needed reassessment due to the growing use of PET, IHC, and flow cytometry. The International Harmonization Project was convened to develop updated response guidelines for lymphoma that could be widely adopted by researchers, industry, and regulators. The updated guidelines were formulated by revising the International Working Group criteria to incorporate PET, IHC, and flow cytometry for defining responses in non‑Hodgkin’s and Hodgkin’s lymphoma. The new guidelines present standardized definitions of response and endpoints that integrate PET, IHC, and flow cytometry, providing a unified framework for lymphoma trials.

Abstract

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 [ 18 F]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.