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Dr. McCloskey on the Results of the ASCERTAIN Trial in MDS

James K. McCloskey II, MD
Published: Wednesday, Jan 08, 2020



James K. McCloskey II, MD, medical oncologist, Division of Leukemia and the Adult Blood and Marrow Stem Cell Transplantation Program, John Theurer Cancer Center, discusses the results of the phase III ASCERTAIN trial in myelodysplastic syndrome (MDS). 

Prior data showed that the oral combination of decitabine and a DNA methyltransferase inhibitor could prolong the exposure to decitabine, similar to when decitabine is given intravenously in patients with MDS. Therefore, the trial evaluated the use of a fixed-dose combination of cedazuridine and decitabine, known as ASTX727, in patients with intermediate- and high-risk disease. Patients were randomized to receive decitabine intravenously in cycle 1 or 2 of therapy, followed by ASTX727 for the remainder of treatment, says McCloskey.

The results showed that the exposure to decitabine was the same, whether patients received decitabine orally or intravenously. These data will move treatment to the outpatient setting, making it easier for patients to receive therapy, says McCloskey. Moreover, these data have established a precedent for examining additional oral therapy combinations in lieu of intravenous therapy.
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James K. McCloskey II, MD, medical oncologist, Division of Leukemia and the Adult Blood and Marrow Stem Cell Transplantation Program, John Theurer Cancer Center, discusses the results of the phase III ASCERTAIN trial in myelodysplastic syndrome (MDS). 

Prior data showed that the oral combination of decitabine and a DNA methyltransferase inhibitor could prolong the exposure to decitabine, similar to when decitabine is given intravenously in patients with MDS. Therefore, the trial evaluated the use of a fixed-dose combination of cedazuridine and decitabine, known as ASTX727, in patients with intermediate- and high-risk disease. Patients were randomized to receive decitabine intravenously in cycle 1 or 2 of therapy, followed by ASTX727 for the remainder of treatment, says McCloskey.

The results showed that the exposure to decitabine was the same, whether patients received decitabine orally or intravenously. These data will move treatment to the outpatient setting, making it easier for patients to receive therapy, says McCloskey. Moreover, these data have established a precedent for examining additional oral therapy combinations in lieu of intravenous therapy.



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