TY - JOUR
T1 - Beyond maximum grade
T2 - modernising the assessment and reporting of adverse events in haematological malignancies
AU - Thanarajasingam, Gita
AU - Minasian, Lori M.
AU - Baron, Frederic
AU - Cavalli, Franco
AU - De Claro, R. Angelo
AU - Dueck, Amylou C.
AU - El-Galaly, Tarec C.
AU - Everest, Neil
AU - Geissler, Jan
AU - Gisselbrecht, Christian
AU - Gribben, John
AU - Horowitz, Mary
AU - Ivy, S. Percy
AU - Jacobson, Caron A.
AU - Keating, Armand
AU - Kluetz, Paul G.
AU - Krauss, Aviva
AU - Kwong, Yok Lam
AU - Little, Richard F.
AU - Mahon, Francois Xavier
AU - Matasar, Matthew J.
AU - Mateos, María Victoria
AU - McCullough, Kristen
AU - Miller, Robert S.
AU - Mohty, Mohamad
AU - Moreau, Philippe
AU - Morton, Lindsay M.
AU - Nagai, Sumimasa
AU - Rule, Simon
AU - Sloan, Jeff
AU - Sonneveld, Pieter
AU - Thompson, Carrie A.
AU - Tzogani, Kyriaki
AU - van Leeuwen, Flora E.
AU - Velikova, Galina
AU - Villa, Diego
AU - Wingard, John R.
AU - Wintrich, Sophie
AU - Seymour, John F.
AU - Habermann, Thomas M.
N1 - Publisher Copyright:
© 2018 Elsevier Ltd
PY - 2018/11
Y1 - 2018/11
N2 - 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.
AB - 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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U2 - 10.1016/S2352-3026(18)30051-6
DO - 10.1016/S2352-3026(18)30051-6
M3 - Review article
C2 - 29907552
AN - SCOPUS:85048309335
SN - 2352-3026
VL - 5
SP - e563-e598
JO - The Lancet Haematology
JF - The Lancet Haematology
IS - 11
ER -