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Decitabine-cedazuridine in patients with MDS and <i>TP53</i> mutations

2025· article· en· W4415734869 on OpenAlexafffund
Samuel Urrutia, Koji Sasaki, Álex Bataller, H. Kantarjian, Guillermo Montalban‐Bravo, James McCloskey, Elizabeth A. Griffiths, Karen Yee, Amer M. Zeidan, Michael R. Savona, Aram Oganesian, Yuri Sano, Harold Keer, Guillermo Garcia‐Manero

Bibliographic record

VenueBlood Advances · 2025
Typearticle
Languageen
FieldMedicine
TopicAcute Myeloid Leukemia Research
Canadian institutionsPrincess Margaret Cancer Centre
FundersTakeda OncologyUniversity of Texas MD Anderson Cancer CenterGenentechSierra OncologyDaiichi Sankyo EuropeGilead SciencesServierCelldex TherapeuticsDaiichi-SankyoPfizerIncyteCTI BiopharmaAgios PharmaceuticalsAlexion PharmaceuticalsApellis PharmaceuticalsCelgeneBioCrystSyndax PharmaceuticalsAcceleronAstex PharmaceuticalsIpsenJazz PharmaceuticalsRegeneron PharmaceuticalsKaryopharm TherapeuticsIpsen BiopharmaceuticalsBristol-Myers SquibbAstraZenecaAstellas PharmaAmgen
KeywordsPropensity score matchingParenteral nutritionHypomethylating agentMyelodysplastic syndromesCohortOverall survivalRetrospective cohort study

Abstract

fetched live from OpenAlex

Patients with myelodysplastic syndromes (MDS) harboring TP53 mutations have poor outcomes.The objective of this study is to evaluate patients with TP53 mutations treated in the phase 2/3 studies of decitabine-cedazuridine (DEC-C) in MDS.We divided patients into three groups: TP53wt, TP53single-hit, and TP53multi-hit.We then performed propensity matching of patients who were treated with DEC-C vs a cohort of patients treated with parenteral hypomethylating agents (HMA).180 patients were analyzed of which 73 (40.5%) had TP53 mutations, 23 (12%) with TP53multi-hit.Patients with TP53multi-hit more frequently had complex cytogenetics (69.5%), and had fewer median number of co-mutations (2.5, IQR 2-3) compared to TP53single-hit(3, IQR 1-5), or TP53wt (4, IQR 3-6) (p=0.002).Patients with TP53multi-hit had a higher chance of lack of response with 39.1% vs 28.1% for TP53single-hit (p=0.2).Patients with TP53mult-hit lost response earlier at 8.2 months, vs 13.2 months for TP53single-hit, and 15.1 months for TP53wt (p=0.1).Median overall survival (mOS) was 11.5 months (95% CI: 8.6 -19.1) for TP53mult-hit, 22.1 months (95% CI: 14.6 -35.9) for TP53single-hit, and 31.7 months (95% CI: 19.5 -51.1) for TP53wt (log-rank, p < 0.005).Propensity scores matched 47 TP53mutpatients treated with DEC-C and 47 TP53mut patients treated with single agent parenteral HMA.Median survival was 13.1 months (95% CI: 8.4 -21.3) for DEC-C vs 8.0 months (95% CI: 5.2 -13.0) for single agent parenteral HMA (log-rank, p=0.047).In patients with MDS harboring TP53mut, DEC-C may improve overall survival compared to parenteral HMA.

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 imitation

Not 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.

metaresearch head score (Codex)0.000
metaresearch head score (Gemma)0.001
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.001
Threshold uncertainty score0.004

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0000.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0010.000

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.

Opus teacher head0.004
GPT teacher head0.263
Teacher spread0.259 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

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".

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Citations0
Published2025
Admission routes2
Has abstractno

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