A plain language summary of the ASCERTAIN trial: oral decitabine and cedazuridine versus intravenous decitabine for MDS or CMML
Bibliographic record
Abstract
Plain Language SummaryWhat 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.This is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-text
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.029 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.006 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.005 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.005 | 0.005 |
| Insufficient payload (model declined to judge) | 0.055 | 0.011 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".