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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: | Laubach, Jacob P.; Moslehi, Javid J.; Francis, Sanjeev A.; San Miguel, Jesús F. CSIC ORCID; Sonneveld, Pieter; Orlowski, R. Z.; Moreau, Philippe; Rosiñol, Laura; Faber Jr., Edward A.; Voorhees, Peter; Mateos, Maria Victoria; Marquez, Loreta; Feng, Huaibao; Desai, Avinash; Velde, Helgi van de; Elliott, Jennifer; Shi, Hongliang; Dow, Edward; Jobanputra, Nishith; Esseltine, Dixie-Lee; Niculescu, Liviu; Anderson, Kenneth; Lonial, Sagar; Richardson, Paul G. | Palabras clave: | Cardio-oncology Cardiac Bortezomib Multiple myeloma |
Fecha de publicación: | 2017 | Editor: | John Wiley & Sons | Citación: | British Journal of Haematology 178(4): 547-560 (2017) | Resumen: | 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. Higher rates of oedema (mostly grade 1/2) were seen in bortezomib-based versus non-bortezomib-based arms in one study and a pooled transplant study analysis. Logistic regression analyses of comparative studies showed no impact on cardiac risk with bortezomib-based versus non-bortezomib-based treatment. Bortezomib-based treatment was associated with low incidences of cardiac events. | URI: | http://hdl.handle.net/10261/169239 | DOI: | 10.1111/bjh.14708 | Identificadores: | doi: 10.1111/bjh.14708 e-issn: 1365-2141 issn: 0007-1048 |
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