Sp11 | Decitabine/cedazuridine Therapy for Very Elderly Patients With Acute Myeloid Leukemia: Single-center Experience in 5 Cases
Year: 2025
Type: article
Abstract: Acute myeloid leukemia (AML) is a neoplastic disease of hematopoietic stem cells that primarily affects the elderly population. In patients unfit for intensive chemotherapy (IC), several therapeutic options are available, mainly based on the use of hypomethylating agents (HMAs). The combination of a HMAs with venetoclax has shown good efficacy and tolerability in this setting. Unfortunately, there is a subset of frail patients considered unfit even for treatment with HMAs and venetoclax. In these cases, the preferred therapeutic options are usually monotherapy with a HMAs or the combination of Glasdegib and low dose cytarabine. Recently, the ASCERTAIN study demonstrated that the oral formulation of decitabine/cedazuridine has a pharmacokinetic and pharmacodynamic profile similar to intravenous decitabine. The oral formulation is particularly attractive option for those patients who have difficulty traveling due to clinical condition, distance from the treatment center, or lack of a caregiver. We analyzed patients treated with decitabine/cedazuridine as per commercial indication at the Hematology Department of the Cosenza Hospital between January and April 2025. A total of 5 patients (2 males and 3 females) were treated. The median age of these patients was 90.2 years (range 89.6–91.3). Cytogenetic analysis was not evaluable in one patient, while the remaining four showed high-risk cytogenetic features. Two patients showed FLT-3 ITD mutations and 2 NPM-1 mutations. One patient was classified as ECOG Performance Status (PS) 1, while the others had an ECOG PS of 2. Patients’ features are shown in Table 1. After a median follow-up of 45 days (range 14–90), a total of 9 cycles were administered. The common adverse events of grade >3 were thrombocytopenia (80%), anemia (60%), neutropenia (40%), diarrhea (20%). Two patients died: 1 due gastrointestinal hemorrhage and 1 due pneumoniae. Only the first patient who completed 3 cycles was evaluable for response and showed a CR. The other two patients on treatment achieved platelet transfusion independence after one month. The main limitations of this study are the very small sample size and the short follow-up period. However, it suggests that oral decitabine/cedazurudine may be a therapeutic option worth considering for elderly patients who are not eligible for HMAs and venetoclax due to clinical or socio-demographic reasons. Further clinical trials and real-world data are needed to confirm these findings.
Authors: A. Bruzzese, E. A. Martino, C. Labanca, F. Mendicino, E. Lucia, V. Olivito, M. Gentile, E. Vigna
Institutions: Azienda Ospedaliera di Cosenza, University of Calabria
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7093122345
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