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Refinement of the Lugano classification response criteria for lymphoma in the era of immunomodulatory therapy

Bruce D. Cheson, Stephen Ansell, Larry Schwartz, Leo I. Gordon, Ranjana Advani, Heather A. Jacene, Axel Hoos, Sally F. Barrington and Philippe Armand

Abstract

Uniformly adopted response criteria are essential for assessment of therapies incorporating conventional chemotherapy and chemoimmunotherapy regimens. Recently, immunomodulatory agents, such as immune checkpoint inhibitors, have demonstrated impressive activity in a broad range of lymphoma histologies. However, these agents may be associated with clinical and imaging findings during treatment suggestive of progressive disease (PD) despite evidence of clinical benefit (e.g., tumor flare or pseudo-progression). Considering this finding as PD could lead to patients being prematurely removed from a treatment from which they actually stand to benefit. This phenomenon has been well described with checkpoint blockade therapy in solid tumors, and anecdotally seen in lymphoma as well. To address this issue in the context of lymphoma immunomodulatory therapy, a workshop was convened to provide provisional recommendations to modify current response criteria in patients receiving these and future agents in clinical trials. The term "Indeterminate Response" (IR) was introduced in order to identify such lesions until confirmed as flare/pseudo-progression or true PD by either biopsy or subsequent imaging.

  • Submitted May 24, 2016.
  • Accepted August 16, 2016.