Oral decitabine/cedazuridine versus intravenous decitabine for acute myeloid leukaemia: A randomised, crossover, registration, pharmacokinetics study

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F24%3A43927598" target="_blank" >RIV/00064173:_____/24:43927598 - isvavai.cz</a>
Alternative codes found
RIV/00216224:14110/24:00137243 RIV/00216208:11120/24:43927598 RIV/65269705:_____/24:00080434 RIV/00843989:_____/24:E0111229
Result on the web
<a href="https://doi.org/10.1111/bjh.19741" target="_blank" >https://doi.org/10.1111/bjh.19741</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1111/bjh.19741" target="_blank" >10.1111/bjh.19741</a>

Result language
angličtina
Original language name
Oral decitabine/cedazuridine versus intravenous decitabine for acute myeloid leukaemia: A randomised, crossover, registration, pharmacokinetics study
Original language description
This study compared decitabine exposure when administered IV (DEC-IV) at a dose of 20 mg/m(2) for 5-days with orally administered decitabine with cedazuridine (DEC-C), as well as the clinical efficacy and safety of DEC-C in patients with acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy. In all, 89 patients were randomised 1:1 to DEC-IV or oral DEC-C (days 1-5 in a 28-day treatment cycle), followed by 5 days of the other formulation in the next treatment cycle. All patients received oral DEC-C for subsequent treatment cycles until treatment discontinuation. Equivalent systemic decitabine exposures were demonstrated (5-day area under the curve ratio between the two decitabine formulations of 99.64 [90% confidence interval 91.23%, 108.80%]). Demethylation rates also were similar (LESS-THAN OR EQUAL TO1.1% difference). Median overall survival (OS), clinical response and safety profile with oral DEC-C were consistent with those previously observed with DEC-IV. Next-generation sequencing was performed to identify molecular abnormalities that impact OS and TP53 mutations were associated with a poor outcome. These findings support the use of oral DEC-C in patients with AML.
Czech name
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Czech description
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Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30205 - Hematology

Publication year
2024
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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