Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies.

Autor:	Thanarajasingam G; Division of Haematology, Mayo Clinic, Rochester, MN, USA. Electronic address: thanarajasingam.gita@mayo.edu., Minasian LM; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Bhatnagar V; Oncology Center for Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Cavalli F; Oncology Institute of Southern Switzerland, Bellinzona, Switzerland., De Claro RA; Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA., Dueck AC; Division of Quantitative Health Sciences Research, Mayo Clinic Arizona, Scottsdale, AZ, USA., El-Galaly TC; Department of Haematology, Clinical Cancer Research Center, Aalborg University Hospital, Aalborg, Denmark., Everest N; Health Resourcing Group, Australian Government Department of Health, Canberra, ACT, Australia., Geissler J; Leukaemia Patient Advocates Foundation, Bern, Switzerland., Gisselbrecht C; Haemato-Oncology Department, Hopital Saint-Louis, Institute Haematology, Paris Diderot University VII, Paris, France; European Medicines Agency, London, UK., Gormley N; Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA., Gribben J; Centre for Haemato-Oncology, Barts Cancer Institute, London, UK., Horowitz M; Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI, USA., Ivy SP; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Jacobson CA; Dana-Farber Cancer Institute, Boston, MA, USA., Keating A; Princess Margaret Cancer Center, Toronto, ON, Canada., Kluetz PG; Oncology Center for Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Kwong YL; Department of Haematology and Haematologic Oncology, University of Hong Kong, Hong Kong Special Administrative Region, China., Little RF; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Matasar MJ; Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Mateos MV; Haematology Department, University Hospital of Salamanca-IBSAL, Salamanca, Spain., McCullough K; Division of Haematology, Mayo Clinic, Rochester, MN, USA., Miller RS; CancerLinQ, American Society of Clinical Oncology, Alexandria, VA, USA., Mohty M; Haematology and Cellular Therapy Department, Sorbonne University, Saint-Antoine Hospital (AP-HP), INSERM UMRs 938, Paris, France., Moreau P; Department of Haematology, University Hospital Nantes, Nantes, France., Morton LM; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Nagai S; Department of Medical Development, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Nair A; Oncology Center for Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Nastoupil L; University of Texas MD Anderson Cancer Center, Houston, TX, USA., Robertson K; Office of Product Review, Therapeutic Goods Administration, Canberra, ACT, Australia., Sidana S; Division of BMT and Cellular Therapy, Stanford University School of Medicine, Stanford, CA, USA., Smedby KE; Department of Medicine Solna, Division of Clinical Epidemiology, Karolinska Institutet, Stockholm, Sweden; Department of Haematology, Karolinska University Hospital, Stockholm, Sweden., Sonneveld P; Department of Haematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands., Tzogani K; European Medicines Agency, London, UK., van Leeuwen FE; Netherlands Cancer Institute, Amsterdam, Netherlands., Velikova G; Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK., Villa D; BC Cancer Centre for Lymphoid Cancer and University of British Columbia, Vancouver, BC, Canada., Wingard JR; Division of Haematology & Oncology, University of Florida College of Medicine, Gainesville, FL, USA., Seymour JF; Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Royal Melbourne Hospital, Melbourne, VIC, Australia; University of Melbourne, Melbourne, VIC, Australia., Habermann TM; Division of Haematology, Mayo Clinic, Rochester, MN, USA.
Jazyk:	angličtina
Zdroj:	The Lancet. Haematology [Lancet Haematol] 2022 May; Vol. 9 (5), pp. e374-e384.
DOI:	10.1016/S2352-3026(22)00045-X
Abstrakt:	Remarkable improvements in outcomes for many haematological malignancies have been driven primarily by a proliferation of novel therapeutics over the past two decades. Targeted agents, immune and cellular therapies, and combination regimens have adverse event profiles distinct from conventional finite cytotoxic chemotherapies. In 2018, a Commission comprising patient advocates, clinicians, clinical investigators, regulators, biostatisticians, and pharmacists representing a broad range of academic and clinical cancer expertise examined issues of adverse event evaluation in the context of both newer and existing therapies for haematological cancers. The Commission proposed immediate actions and long-term solutions in the current processes in adverse event assessment, patient-reported outcomes in haematological malignancies, toxicities in cellular therapies, long-term toxicity and survivorship in haematological malignancies, issues in regulatory approval from an international perspective, and toxicity reporting in haematological malignancies and the real-world setting. In this follow-up report, the Commission describes progress that has been made in these areas since the initial report. Competing Interests: Declaration of interests CAJ reports personal fees from Kite/Gilead, Novartis, BMS/Celgene, Precision Biosciences, Nkarta, AbbVie, Bluebird Bio, Epizyme, Lonza, and Ipsen, outside the submitted work. DV reports personal fees from AbbVie, AstraZeneca, Kite/Gilead, Kyowa Kirin, Sandoz Canada, Nanostring, Immunovaccine, Roche, Celgene, Seattle Genetics, and Lundbeck/Teva; and research funding (to his institution) from AstraZeneca and Roche, outside the submitted work. GV reports personal fees from Roche, Eisai, Novartis, and Seattle Genetics; and grants from Breast Cancer Now, EORTC, Yorkshire Cancer Research, Pfizer, and IQVIA, outside the submitted work. JaG reports grants from Novartis, Pfizer, Bristol-Myers Squibb, Incyte, Takeda, Servier, UCB, Amgen, Roche, Alnylam, Boehringer-Ingelheim, Biomarin, Daiichi Sankyo, Janssen, Sobi, Gilead, and Bayer, outside the submitted work. JFS reports grants, personal fees, non-financial support, and speakers bureau participation for AbbVie and Roche; personal fees and non-financial support from BMS; personal fees from Genentech, Mei Pharma, Morphosys, Sunesis, and Takeda; and grants and personal fees from Janssen, outside the submitted work. JRW reports personal fees from Merck, Celgene, Cidara, ReViral, Shire, Ansun, Janssen, and Behring, outside the submitted work. KM reports grants from Pfizer, outside the submitted work. LN reports honoraria from ADC Therapeutics, Bayer, and Morphosys; grants and honoraria from BMS/Celgene, Epizyme, Genentech, Gilead/Kite, Novartis, Pfizer, Takeda, and TG Therapeutics; and grants from Caribou Biosciences and IGM Biosciences, outside the submitted work. M-VM reports personal fees from Janssen, BMS-Celgene, Takeda, Amgen, Sanofi, Oncopeptides, Adaptive, GSK, AbbVie, Roche, Seattle Genetics, Pfizer, and Regeneron, outside the submitted work. MH reports grants from U24 CA076518 National Cancer Institute and grants from U24 HL138660 National Heart, Lung and Blood Institute, during the conduct of the study; grants from Amgen, Vor BioPharma, Gamida Cell, Medac, Magenta Therapeutics, Astellas, OncoImmune, and Genentech; and consulting fees from AlloVir, outside the submitted work. MJM reports personal fees from Genentech, Roche, GlaxoSmithKline, Bayer, Pharmacyclics, Janssen, Seattle Genetics, Immunovaccine Technology, and Takeda; consulting advisory roles for Merck, Juno Therapeutics, Teva, and Daiichi Sankyo; research funding from IGM Biosciences; and a consulting advisory role and research funding from Rocket Medical, outside the submitted work. PM reports personal fees from Janssen, Celgene, BMS, AbbVie, Sanofi, and Amgen, outside the submitted work. PS reports research support from Celgene, Amgen, Janssen, and Takeda; and honoraria and serving on advisory boards for Celgene, Janssen, Amgen, Takeda, BMS, and SkylineDx, outside the submitted work. SS reports grants and consulting fees from BMS, Janssen, and Magenta; grants from Allogene; and consulting fees from Oncopeptides, outside the submitted work. TCE-G reports previous employment at Roche and personal fees from AbbVie, outside the submitted work. All other authors declare no competing interests. (Copyright © 2022 Elsevier Ltd. All rights reserved.)
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