Background In the pivotal authorisation trial of carfilzomib, patients with severe cardiovascular abnormalities (NYHA III or IV), clinically significant and uncontrolled, were not included.
Purpose The aim of this study was to analyse the cardiovascular events (CVAE) associated with carfilzomib in patients in whom an electrocardiogram was performed prior to starting treatment and compare these data with those of the pivotal trial.
Material and methods Retrospective observational study in which all patients treated with carfilzomib were included. The data obtained from the electronic medical record were: age and comorbidities at diagnosis, schemes used prior to carfilzomib, dose of carfilzomib and development of CVAE after the use of carfilzomib.
Results Thirty-six patients (19 males) with a median age 59 years (RIQ 53–67) were included. Seventy-eight per cent had comorbidities at the time of diagnosis, the most frequent being arterial hypertension (HTA) (16), followed by diabetes mellitus and dyslipaemia (seven in both). The average of previous regimens was one (30), with VCD (bortezomib, cyclophosphamide and dexamethasone) in 28 patients. In 34 patients the scheme used was KRD (carfilzomib, lenalidomide and dexamethasone) at a dose of 27 mg/m2. In two patients the dose was reduced due to adverse effects (hepatotoxicity and nonspecific toxicity).
The incidence of all grades CVAE was 19.4% (three congestive heart failure, two paroxysmal atrial fibrillation, and one transient ischaemia and new onset HTA). Of all of them, 71% presented as comorbidity to the diagnosis of hypertension. Median age of patients was 65 years (RIQ 65–76). Two patients discontinued the treatment, three patients required modification of the diuretic treatment and in one patient the infusion time of carfilzomib was modified.
Conclusion As in the ASPIRE study, patients are referred to the cardiology service prior to starting treatment and the expected results are similar (19.4% vs 22.3% in ASPIRE). The most vulnerable patients of developing CVE were those over 65 years of age, since they present more comorbidities pre-treatment. However, it should be mentioned that myeloma itself, or the corticosteroids, can also contribute to cardiovascular deterioration.
References and/or acknowledgements Stewart AK, Rajkumar SV, Kimopoulos MA, et al; ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med 2015;372:142–52.
No conflict of interest.
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