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Título
A retrospective analysis of 3954 patients in phase 2/3 trials of bortezomib for the treatment of multiple myeloma: towards providing a benchmark for the cardiac safety profile of proteasome inhibition in multiple myeloma
Autor(es)
Materia
Cardiac
Bortezomib
Cardio-oncology
Multiple myeloma
Clasificación UNESCO
3205.04 Hematología
Fecha de publicación
2017-05
Editor
British Journal of Haematology
Citación
Laubach, J.P., Moslehi, J.J., Francis, S.A., San Miguel, J.F., Sonneveld, P., Orlowski, R.Z., Moreau, P., Rosiñol, L., Faber, E.A., Jr, Voorhees, P., Mateos, M.-V., Marquez, L., Feng, H., Desai, A., van de Velde, H., Elliott, J., Shi, H., Dow, E., Jobanputra, N., Esseltine, D.-L., Niculescu, L., Anderson, K.C., Lonial, S. and Richardson, P.G. (2017), A retrospective analysis of 3954 patients in phase 2/3 trials of bortezomib for the treatment of multiple myeloma: towards providing a benchmark for the cardiac safety profile of proteasome inhibition in multiple myeloma. Br J Haematol, 178: 547-560. https://doi.org/10.1111/bjh.14708
Resumen
[EN] This retrospective analysis aimed to establish the overall cardiac safety profile of bortezomib using patient-level data from one phase 2 and seven phase 3 studies in previously untreated and relapsed/refractory multiple myeloma (MM). Seven clinically relevant primary [congestive heart failure (CHF), arrhythmias, ischaemic heart disease (IHD), cardiac death] and secondary (hypertension, dyspnoea, oedema) cardiac endpoints were defined based on MedDRA v16.0 preferred terms. 2509 bortezomib-treated patients and 1445 patients in non-bortezomib-based control arms were included. The incidence of grade ≥3 CHF was 1·3–4·0% in studies in relapsed/refractory MM and 1·2–4·7% in previously untreated MM (2·0–7·6% all grades), with no significant differences between bortezomib- and non-bortezomib-based arms in comparative studies. Incidences of arrhythmias (1·3–5·9% grade ≥2; 0·6–4·1% grade ≥3), IHD (1·2–2·9% all grades; 0·4–2·7% grade ≥3) and cardiac death (0–1·4%) were low, with no differences between bortezomib-based and non-bortezomib-based arms.
URI
ISSN
0007-1048
DOI
10.1111/bjh.14708
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