Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessm
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IMMUNO-ONCOLOGY (RM BUKOWSKI AND JH FINKE, SECTION EDITORS)
Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy Sirisha L. Mushti 1 & Flora Mulkey 1 & Shenghui Tang 1 & Harpreet Singh 1 & Steven J. Lemery 1 & Kirsten B. Goldberg 2 & Rajeshwari Sridhara 3 & Patricia Keegan 2 & Paul G. Kluetz 1,2 & Richard Pazdur 1,2 & Marc R. Theoret 1,2 & Julia A. Beaver 1,2
# Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Purpose of Review This review provides a comprehensive assessment of recent literature reports describing atypical response patterns observed with immune checkpoint inhibitors (ICIs), modifications to response evaluation criteria for ICIs, and treatment beyond progression in clinical trials. Recent Findings Certain response patterns such as durable response, pseudoprogression, hyperprogression, and dissociated responses can be seen with ICI treatment. These patterns carry differing prognoses and are associated with varied factors. There are multiple modifications of standard Response Evaluation Criteria in Solid Tumors (RECIST) that have been proposed to better characterize immunotherapy response; however, standard RECIST1.1 remains most commonly used in clinical trials. Treatment beyond progression varies in frequency and benefit depending on assessment criteria and cancer type. Summary Future research incorporating modified imaging criteria and biomarker assessments may serve to clarify who will benefit most from treatment beyond progression. Keywords Immunotherapy . Response criteria . Solid tumors . Atypical response patterns . Treatment beyond progression . RECIST
Introduction Cancer immunotherapies, in particular immune checkpoint inhibitors (ICIs), have brought substantial change to the Sirisha L. Mushti and Flora Mulkey contributed equally to this work. This article is part of the Topical Collection on Immuno-oncology * Sirisha L. Mushti [email protected] Flora Mulkey [email protected] 1
Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
2
Oncology Center of Excellence, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
3
Oncology Center of Excellence (Contractor), Brillient Corporation, Reston, USA
treatment landscape. ICIs include drugs targeting the cytotoxic T lymphocyte–associated antigen 4 (CTLA-4) or the programmed cell death protein 1 (PD-1) receptor or its ligands (PD-L1 and PD-L2). These drugs have been transformative for many oncologic diseases, providing overall survival (OS) benefits and new therapeutic options for patients [1]. As of March 2020, the US Food and Drug Administration (FDA) has approved ICIs across multiple cancer-specific and tissue-agnostic indications, including but not limited to melanoma, lung cancer, bladder cancer, kidney cancer, lymphoma, and microsatellite instability (MSI)-high solid tumors (the fi
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