Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data.

Autor:	Reynolds KL; Division of Hematology and Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA kreynolds7@partners.org., Arora S; Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, Florida, USA., Elayavilli RK; Program Director, Project Data Sphere, Cary, North Carolina, USA., Louv WC; President, Project Data Sphere, Cary, North Carolina, USA., Schaller TH; Program Director, Project Data Sphere, Cary, North Carolina, USA., Khandelwal A; Global Head of Portfolio Strategy & Innovation, Merck KGaA, Darmstadt, Germany., Rothenberg M; Former Chief Medical Officer, Pfizer Inc, New York, New York, USA., Khozin S; Chief Executive Officer, ASCO CancerLinQ LLC, Alexandria, Virginia, USA., Guidon AC; Division of Neuromuscular Disorders, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA., Dougan M; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA., Zubiri L; Division of Hematology and Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA., Petrillo L; Division of Palliative Care, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA., Sise ME; Division of Nephrology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA., Villani AC; Center for Immunology and Inflammatory Diseases and Center for Cancer Research, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA., Johnson DB; Division of Hematology/Oncology, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Rahma O; Center for Immuno-Oncology and Gastroenterology Cancer Center, Dana-Farber Cancer Institute, Boston, Massachusetts, USA., Sharon E; Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland, USA.
Jazyk:	angličtina
Zdroj:	Journal for immunotherapy of cancer [J Immunother Cancer] 2021 Jul; Vol. 9 (7).
DOI:	10.1136/jitc-2021-002896
Abstrakt:	Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, improving outcomes in patients with advanced malignancies. The use of ICIs in clinical practice, and the number of ICI clinical trials, are rapidly increasing. The use of ICIs in combination with other forms of cancer therapy, such as chemotherapy, radiotherapy, or targeted therapy, is also expanding. However, immune-related adverse events (irAEs) can be serious in up to a third of patients. Critical questions remain surrounding the characteristics and outcomes of irAEs, and how they may affect the overall risk-benefit relationship for combination therapies. This article proposes a framework for irAE classification and reporting, and identifies limitations in the capture and sharing of data on irAEs from current clinical trial and real-world data. We outline key gaps and suggestions for clinicians, clinical investigators, drug sponsors, patients, and other stakeholders to make these critical data more available to researchers for pooled analysis, to advance contemporary understanding of irAEs, and ultimately improve the efficacy of ICIs. Competing Interests: Competing interests: KLR receives support from Teladoc and Project Data Sphere. MR owns shares of Pfizer Inc. ACG has served on advisory boards/consulted with Alexion, RA Pharma (UCB), and Momenta (Jansen). She also receives support from Project Data Sphere. MD has received support from Novartis, Eli Lilly, Moderna, Tillotts Pharma, ORIC Pharmaceuticals, and Partner Therapeutics. He is engaged with Moderna and Neoleukin Therapeutics. LZ has received support from Merck US. DBJ has received support from BMS and Incyte and serves on advisory boards for Array Biopharma, BMS, Catalyst, Iovance, Jansen, Merck, Novartis, and Oncosec. OR has received support from Merck, Celgene, Five Prime, GSK, Bayer, Roche, Puretech, Imvacx, and Sobi, has an immunotherapy patent pending, and serves as CMO of Outcomes4me. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu