A plain language summary of the ASCERTAIN trial: oral decitabine and cedazuridine versus intravenous decitabine for MDS or CMML

What is this summary about?This summary describes results from a phase 3 clinical trial called ASCERTAIN.Researchers compared two treatments in people with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML), either of which can develop into acute myeloid leukemia (AML). One group was treated with oral decitabine and cedazuridine (oral DEC-C) and the other with intravenous decitabine.Treatment was given in a series of cycles. In the first cycle, people were randomly assigned to receive oral DEC-C or intravenous decitabine and then switched to the other treatment in the second cycle. After the first two cycles, everyone received oral DEC-C. The aim was to compare whether the same amount of decitabine reached people’s bloodstream in a certain time period after receiving oral DEC-C or intravenous decitabine (known as pharmacokinetics). Researchers also looked at how long people lived while taking treatment, how long people lived without developing AML, and the side effects from receiving treatment. What were the results?The amount of decitabine in the bloodstream during the first 5 days of treatment was almost the same (99% similar) between people who received oral DEC-C and those who received intravenous decitabine. Among people treated with oral DEC-C, the median overall survival was 31.8 months. Overall, people lived without developing AML for a median of 31.7 months. Among people who required red blood cell transfusion at the start of the trial, 52% achieved transfusion independence during the trial with oral DEC-C. Side effects of oral DEC-C were similar to those of intravenous decitabine,most commonly thrombocytopenia and neutropenia. There were five treatment-related deaths during the trial; two in the oral DEC-C group and three in the intravenous decitabine group. What do the results mean?Oral DEC-C was as effective, and had similar side effects, as treatment with intravenous decitabine. Although the trial did not focus on quality of life, oral medicines require fewer visits to a clinic compared with intravenous medicines, which could make it easier for people to stay on treatment. This trial supports using oral DEC-C for treating people with MDS or CMML.[Box: see text].

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Publication Details

Journal
Future Oncology
Published
2025-03-06
DOI
https://doi.org/10.1080/14796694.2025.2468578
Citations
1
Primary Topic
Cancer Treatment and Pharmacology
Type
article
Field-Weighted Citation Impact
1.05
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article

A plain language summary of the ASCERTAIN trial: oral decitabine and cedazuridine versus intravenous decitabine for MDS or CMML

Aram Oganesian, Mary‐Margaret Keating, James McCloskey, Aref Al‐Kali et al.
1 citations
Future Oncology
Cancer Treatment and Pharmacology
1.05
article

A plain language summary of the ASCERTAIN trial: oral decitabine and cedazuridine versus intravenous decitabine for MDS or CMML

Aram Oganesian, Mary‐Margaret Keating, James McCloskey, Aref Al‐Kali, H. Joachim Deeg, Gail J. Roboz, Brian F. Leber, Amy Elizabeth Dezern, Harold Keer, Aditi Shastri, Lambert Busque, Rena J. Buckstein, Michael Robert Savona, Casey Lee O'Connell, Karen W L Yee, Olatoyosi M. Odenike, Elizabeth A. Griffiths, Guillermo Garcia‐Manero, Mitchell Sabloff, Amer Methqal Zeidan, Joseph Maly, Mohammad Azab, Salman Fazal, Nancy Yan Zhu, Nashat Gabrail, Harshad Amin
article en
1 citations

Abstract

What is this summary about?This summary describes results from a phase 3 clinical trial called ASCERTAIN.Researchers compared two treatments in people with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML), either of which can develop into acute myeloid leukemia (AML). One group was treated with oral decitabine and cedazuridine (oral DEC-C) and the other with intravenous decitabine.Treatment was given in a series of cycles. In the first cycle, people were randomly assigned to receive oral DEC-C or intravenous decitabine and then switched to the other treatment in the second cycle. After the first two cycles, everyone received oral DEC-C. The aim was to compare whether the same amount of decitabine reached people’s bloodstream in a certain time period after receiving oral DEC-C or intravenous decitabine (known as pharmacokinetics). Researchers also looked at how long people lived while taking treatment, how long people lived without developing AML, and the side effects from receiving treatment. What were the results?The amount of decitabine in the bloodstream during the first 5 days of treatment was almost the same (99% similar) between people who received oral DEC-C and those who received intravenous decitabine. Among people treated with oral DEC-C, the median overall survival was 31.8 months. Overall, people lived without developing AML for a median of 31.7 months. Among people who required red blood cell transfusion at the start of the trial, 52% achieved transfusion independence during the trial with oral DEC-C. Side effects of oral DEC-C were similar to those of intravenous decitabine,most commonly thrombocytopenia and neutropenia. There were five treatment-related deaths during the trial; two in the oral DEC-C group and three in the intravenous decitabine group. What do the results mean?Oral DEC-C was as effective, and had similar side effects, as treatment with intravenous decitabine. Although the trial did not focus on quality of life, oral medicines require fewer visits to a clinic compared with intravenous medicines, which could make it easier for people to stay on treatment. This trial supports using oral DEC-C for treating people with MDS or CMML.[Box: see text].

Future OncologyVol. 21(8)
Roswell Park Comprehensive Cancer Center (US), Albert Einstein College of Medicine (US), Allegheny Health Network (US), Sunnybrook Health Science Centre (CA), Hackensack University Medical Center (US), The University of Texas MD Anderson Cancer Center (US), Johns Hopkins University (US), University of Alberta (CA), Cornell University (US), Juravinski Cancer Centre (CA), Keck Hospital of USC (US), Queen Elizabeth II Health Sciences Centre (CA), Ottawa Hospital (CA), Health Sciences Centre (CA), Princess Margaret Cancer Centre (CA), Yale Cancer Center (US), Boca Raton Regional Hospital (US), Hôpital Maisonneuve-Rosemont (CA), Yale University (US), University of Chicago (US), Fred Hutch Cancer Center (US), Presbyterian Hospital (US), Gabrail Cancer Center (US), MedSIR (Spain) (ES), Taiho Oncology (United States) (US), Mayo Clinic in Florida (US), Sidney Kimmel Comprehensive Cancer Center (US), Weill Cornell Medicine (US), Astex Pharmaceuticals, Montefiore Einstein Comprehensive Cancer Center, Vanderbilt University Medical Center (US)
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