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Myelodysplastic syndrome and acute myeloid leukaemia in patients treated with PARP inhibitors: a safety meta-analysis of randomised controlled trials and a retrospective study of the WHO pharmacovigilance database

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Myelodysplastic syndrome and acute myeloid leukaemia in patients treated with PARP inhibitors: a safety meta-analysis of randomised controlled trials and a retrospective study of the WHO pharmacovigilance database

The Lancet Haematology

Fecha de publicación: 18 de diciembre de 2021

DOI: https://doi.org/10.1016/S2352-3026(20)30360-4

Autores: Pierre-Marie Morice, PhD, Alexandra Leary, MD, Charles Dolladille, MD, Basile Chrétien, PharmD, Laurent Poulain, PhD, Antonio González-Martín, MD, Kathleen Moore, MD, Eileen Mary O’Reilly, MD, Prof Isabelle Ray-Coquard, M, Prof Joachim Alexandre, MD 

Background: Poly(ADP-ribose) polymerase (PARP) inhibitors have shown efficacy and acceptable safety in a range of neoplasms, particularly in ovarian cancers. However, some concerns have emerged regarding rare and delayed adverse events including cases of myelodysplastic syndrome and acute myeloid leukaemia, for which data are scarce. The aim of this study was to estimate the risk of myelodysplastic syndrome and acute myeloid leukaemia related to PARP inhibitors, via a systematic review and safety meta-analysis, and to describe clinical features of PARP inhibitor-related myelodysplastic syndrome and acute myeloid leukaemia cases reported in WHO’s pharmacovigilance database (VigiBase).

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