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Lancet Haematol. 2018 Jun 12. pii: S2352-3026(18)30051-6. doi: 10.1016/S2352-3026(18)30051-6. [Epub ahead of print]

Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.

Author information

1
Division of Haematology, Mayo Clinic, Rochester, MN, USA. Electronic address: thanarajasingam.gita@mayo.edu.
2
National Cancer Institute, National Institutes of Health, Department of Health & Human Services, Bethesda, MD, USA.
3
Division of Haematology, University of Liege, Liege, Belgium.
4
Oncology Institute of Southern Switzerland, Bellinzona, Switzlerand.
5
Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
6
Department of Health Sciences Research, Mayo Clinic, Scottsdale, AZ, USA.
7
Department of Haematology, Aalborg University Hospital, Aalborg Denmark.
8
Haematology Clinical Evaluation Unit, Therapeutic Goods Administration, Department of Health, Symondston, ACT, Australia.
9
Leukaemia Patient Advocates Foundation, Bern, Switzerland.
10
Haemato-Oncology Department, Hopital Saint-Louis, Paris Diderot University VII, Paris, France.
11
Centre for Haemato-Oncology, Barts Cancer Institute, London, UK.
12
Division of Haematology and Oncology, Medical College of Wisconsin, Milwaukee, WI, USA.
13
Division of Haematologic Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
14
Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
15
Department of Haematology and Haematologic Oncology, University of Hong Kong, Hong Kong, China.
16
University of Bordeaux Cancer Institute, Bordeaux, France.
17
Lymphoma and Adult BMT Services, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
18
Haematology Department, University Hospital of Salamanca-IBSAL, Salamanca, Spain.
19
Division of Haematology, Mayo Clinic, Rochester, MN, USA.
20
CancerLinQ, American Society of Clinical Oncology, Alexandria, VA, USA.
21
Haematology and Cellular Therapy Department, Saint-Antoine Hospital, University Pierre & Marie Curie, Paris, France.
22
University Hospital of Nantes, Nantes, France.
23
University of Tokyo, Tokyo, Japan; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
24
Plymouth University Medical School, Plymouth, UK.
25
Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
26
Department of Haematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.
27
European Medicines Agency, London, UK.
28
Netherlands Cancer Institute, Amsterdam, Netherlands.
29
Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.
30
Division of Medical Oncology, British Columbia Cancer Agency, University of British Columbia, Vancouver, BC, Canada.
31
Division of Haematology & Oncology, University of Florida College of Medicine, Gainesville, FL, USA.
32
Myelodysplastic Syndrome (MDS) Alliance and MDS UK Patient Support Group, London, UK.
33
Department of Haematology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Royal Melbourne Hospital, Melbourne, VIC, Australia; University of Melbourne, Melbourne, VIC, Australia.

Abstract

Tremendous progress in treatment and outcomes has been achieved across the whole range of haematological malignancies in the past two decades. Although cure rates for aggressive malignancies have increased, nowhere has progress been more impactful than in the management of typically incurable forms of haematological cancer. Population-based data have shown that 5-year survival for patients with chronic myelogenous and chronic lymphocytic leukaemia, indolent B-cell lymphomas, and multiple myeloma has improved markedly. This improvement is a result of substantial changes in disease management strategies in these malignancies. Several haematological malignancies are now chronic diseases that are treated with continuously administered therapies that have unique side-effects over time. In this Commission, an international panel of clinicians, clinical investigators, methodologists, regulators, and patient advocates representing a broad range of academic and clinical cancer expertise examine adverse events in haematological malignancies. The issues pertaining to assessment of adverse events examined here are relevant to a range of malignancies and have been, to date, underexplored in the context of haematology. The aim of this Commission is to improve toxicity assessment in clinical trials in haematological malignancies by critically examining the current process of adverse event assessment, highlighting the need to incorporate patient-reported outcomes, addressing issues unique to stem-cell transplantation and survivorship, appraising challenges in regulatory approval, and evaluating toxicity in real-world patients. We have identified a range of priority issues in these areas and defined potential solutions to challenges associated with adverse event assessment in the current treatment landscape of haematological malignancies.

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