TY - JOUR
T1 - Reaching beyond maximum grade
T2 - progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies
AU - Thanarajasingam, Gita
AU - Minasian, Lori M.
AU - Bhatnagar, Vishal
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 - Gormley, Nicole
AU - Gribben, John
AU - Horowitz, Mary
AU - Ivy, S. Percy
AU - Jacobson, Caron A.
AU - Keating, Armand
AU - Kluetz, Paul G.
AU - Kwong, Yok Lam
AU - Little, Richard F.
AU - Matasar, Matthew J.
AU - Mateos, Maria Victoria
AU - McCullough, Kristen
AU - Miller, Robert S.
AU - Mohty, Mohamad
AU - Moreau, Philippe
AU - Morton, Lindsay M.
AU - Nagai, Sumimasa
AU - Nair, Abhilasha
AU - Nastoupil, Loretta
AU - Robertson, Kaye
AU - Sidana, Surbhi
AU - Smedby, Karin E.
AU - Sonneveld, Pieter
AU - Tzogani, Kyriaki
AU - van Leeuwen, Flora E.
AU - Velikova, Galina
AU - Villa, Diego
AU - Wingard, John R.
AU - Seymour, John F.
AU - Habermann, Thomas M.
N1 - Publisher Copyright: © 2022 Elsevier Ltd
PY - 2022/5
Y1 - 2022/5
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85129780083&partnerID=8YFLogxK
U2 - 10.1016/s2352-3026(22)00045-x
DO - 10.1016/s2352-3026(22)00045-x
M3 - Review article
C2 - 35483398
AN - SCOPUS:85129780083
SN - 2352-3026
VL - 9
SP - e374-e384
JO - The Lancet Haematology
JF - The Lancet Haematology
IS - 5
ER -