Key result
Treatment with oral decitabine/cedazuridine for chronic myelomonocytic leukemia was associated with the development of acute, reversible non-ischemic cardiomyopathy in an 85-year-old woman.
Why the study?
There were no documented incidences in the literature or clinical trials of reversible cardiomyopathy associated with oral decitabine-cedazuridine.
Case Report (n=1)
No
This case report provides the first documented evidence of reversible cardiomyopathy and heart failure associated with the novel oral combination of decitabine/cedazuridine.
May support oral decitabine in CMML; extends HMA options while informing cardiac safety monitoring in oncology.
BACKGROUND: Hypomethylating agents (HMAs) have shown efficacy in the treatment of hematological malignancies and are indicated for the treatment of chronic myelomonocytic leukemia (CMML). While the HMA decitabine, in its intravenous formulation, has been used since 2006 for the treatment of CMML, use of its oral formulation has been limited by poor bioavailability due to first-pass metabolism by the enzyme cytidine deaminase. The dose of intravenous decitabine is limited by toxicities such as cardiomyopathy and heart failure. Therefore, cedazuridine was developed as an inhibitor of cytidine deaminase. Cedazuridine decreases the first-pass metabolism of oral decitabine allowing therapeutic levels to be achieved at lower doses, and thus, the novel oral combination of cedazuridine with decitabine was developed. While cardiomyopathy and heart failure are well-established adverse effects associated with intravenous decitabine alone, there to our knowledge there have been no documented incidences of reversible cardiomyopathy in the literature or in patients who participated in the phase 2 and phase 3 clinical trials of oral decitabine-cedazuridine. CASE: This case study presents an 85 year-old Caucasian female with CMML who developed cardiomyopathy and heart failure with reduced ejection fraction after completing 5 cycles of therapy with decitabine/cedazuridine. Furthermore, her symptoms and cardiac function recovered upon discontinuation of the drug. CONCLUSIONS: We present an occurrence of reversible cardiomyopathy in a patient who completed 5 cycles of decitabine/cedazuridine, an oral combination therapy developed to enhance oral bioavailability of decitabine thereby limiting its adverse effects. As the decitabine/cedazuridine combination therapy rises in popularity due to its convenient oral formulation, more trials are needed to understand the prevalence of cardiomyopathy with this drug and to discover preventative strategies for cardiotoxic effects.
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Sheel et al. (2023) conducted a case report in Chronic myelomonocytic leukemia (n=1). Decitabine/cedazuridine was evaluated on Development of cardiomyopathy. Treatment with oral decitabine/cedazuridine for chronic myelomonocytic leukemia was associated with the development of acute, reversible non-ischemic cardiomyopathy in an 85-year-old woman.
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