Evidence mapPaperPMID 39519198Full record

Trial reportInternational journal of molecular sciences2024

Translational Research on Azacitidine Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients (QOL-ONE Trans-2).

Esther Natalie Oliva, Maria Cuzzola, Matteo Della Porta, Anna Candoni, Prassede Salutari, Giuseppe A Palumbo, Gianluigi Reda, Giuseppe Iannì, Matteo Zampini, Saverio D'Amico and 15 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in International journal of molecular sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Esther Natalie OlivaHematology Unit, Grande Ospedale Metropolitano Bianchi Melacrino Morelli, 89124 Reggio di Calabria, Italy.ORCID 0000-0001-9238-5734
Maria CuzzolaUOSD Tipizzazione Tissutale, Grande Ospedale Metropolitano Bianchi Melacrino Morelli, 89124 Reggio di Calabria, Italy.
Matteo Della PortaIRCCS Humanitas Research Hospital, 20089 Milan, Italy.
Anna CandoniClinica Ematologica, ASUFC, University of Udine, 33100 Udine, Italy.ORCID 0000-0003-4436-1310
Prassede SalutariDipartimento Oncologico-Ematologico Ospedale Civile Spirito Santo Pescara, 65124 Pescara, Italy.
Giuseppe A PalumboDipartimento di Scienze Mediche Chirurgiche e Tecnologie Avanzate "G.F. Ingrassia", University of Catania, 95123 Catania, Italy.ORCID 0000-0003-1859-6319
Gianluigi RedaHematology Department, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, 20100 Milan, Italy.
Giuseppe IannìDielnet SRL, CRO Reggio Calabria, 89124 Reggio Calabria, Italy.
Matteo ZampiniIRCCS Humanitas Research Hospital, 20089 Milan, Italy.ORCID 0000-0002-9952-1142
Saverio D'AmicoIRCCS Humanitas Research Hospital, 20089 Milan, Italy.
Giovanni TripepiIFC-CNR Institute of Clinical Physiology Reggio Calabria, 89124 Reggio Calabria, Italy.
Debora CapelliClinica di Ematologia Azienda Ospedaliera Universitaria, Ospedali Riuniti di Ancona, 60126 Ancona, Italy.
Caterina AlatiHematology Unit, Grande Ospedale Metropolitano Bianchi Melacrino Morelli, 89124 Reggio di Calabria, Italy.
Maria Concetta CannatàUOSD Medical Genetics, Great Metropolitan Hospital, 89124 Reggio Calabria, Italy.
Pasquale NiscolaUO di Ematologia, Ospedale Sant'Eugenio, 00144 Roma, Italy.ORCID 0000-0002-2226-6518
Bianca SerioDipartimento di Oncoematologia, AOU San Giovanni di Dio e Ruggi D'Aragona, 84125 Salerno, Italy.
Santina BarillàHematology Unit, Grande Ospedale Metropolitano Bianchi Melacrino Morelli, 89124 Reggio di Calabria, Italy.
Pellegrino MustoDepartment of Precision and Translational Medicine with Ionian Area, "Aldo Moro" University School of Medicine, 70121 Bari, Italy.ORCID 0000-0003-3277-6594
Ernesto VignaUO di Ematologia, Ospedale L'Annunziata, 87100 Cosenza, Italy.
Lorella Maria Antonia MelilloUOC Ematologia e Trapianto di Cellule Staminali Emopoietiche, Policlinico Foggia Ospedaliero-Universitario, 71122 Foggia, Italy.
Rocco TripepiNephology, Dialysis and Transplantation Unit-GOM "Bianchi-Melacrino-Morelli", 89124 Reggio Calabria, Italy.
Maria Elena ZannierClinica Ematologica, ASUFC, University of Udine, 33100 Udine, Italy.
Yasuhito NannyaDepartment of Hematology/Oncology, The Institute of Medical Science, The University of Tokyo, Tokyo 108-0071, Japan.ORCID 0000-0002-6526-0992
Seishi OgawaInstitute for the Advanced Study of Human Biology, Kyoto University, Kyoto 606-8303, Japan.
Corrado MammìUOSD Medical Genetics, Great Metropolitan Hospital, 89124 Reggio Calabria, Italy.

Funding

Unconditional funding support for the undertaking of this trial was provided by BMS. N/A
6 · The paper itself

Abstract

The achievement of complete remission (CR) is crucial for acute myeloid leukemia (AML) patients undertaking curative therapy, but relapse often occurs within months, highlighting the need for strategies to prolong disease-free survival (DFS). Our phase III study compared the efficacy and safety of azacitidine (AZA) to best supportive care (BSC) in elderly AML patients who achieved CR following intensive induction and consolidation therapy. This ancillary study (QOL-ONE Trans-2) evaluated biological changes in bone marrow using Next-Generation Sequencing (NGS). We analyzed baseline, randomization, and 6-month post-remission samples from 24 patients (median age of 71 and 12 males). High-throughput NGS targeted 350 myeloid malignancy-related genes, considering variants with a variant allele frequency ≥ 4%. At diagnosis, all patients had 5 to 17 (median = 10) mutations, with DNMT3A (42%), NPM1 (33%), and TET2 (33%) being most frequent. FANCA mutations in four patients were linked to a higher relapse risk (HR = 4.96,

Indexed as

AzacitidineLeukemia, Myeloid, AcuteNucleophosminRemission InductionAgedAged, 80 and overAntimetabolites, AntineoplasticDioxygenasesDisease-Free SurvivalDNA-Binding ProteinsDNA (Cytosine-5-)-MethyltransferasesDNA Methyltransferase 3AFemaleHigh-Throughput Nucleotide SequencingHumansMaleAntimetabolites, AntineoplasticAzacitidineDioxygenasesDNA-Binding ProteinsDNA (Cytosine-5-)-MethyltransferasesDNA Methyltransferase 3ADNMT3A protein, humanNPM1 protein, humanNucleophosminTET2 protein, humanacute myeloid leukemiaazacitidinedisease-free survivalmalignancy-related genes

Identifiers

PMID39519198
PMCPMC11545844

What Socratic holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.