Evidence map›Paper›PMID 35728048›Full record

Trial reportBlood advances2022

Pevonedistat plus azacitidine vs azacitidine alone in higher-risk MDS/chronic myelomonocytic leukemia or low-blast-percentage AML.

Lionel Adès, Larisa Girshova, Vadim A Doronin, María Díez-Campelo, David Valcárcel, Suman Kambhampati, Nora-Athina Viniou, Dariusz Woszczyk, Raquel De Paz Arias, Argiris Symeonidis and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Blood advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03268954 (A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia), which is not on this map. Cited by 81 papers.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed
17.2field-weighted citation impact, top 1% of its field
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.

NCT03268954 phase3completednot on this map

A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia

TypeinterventionalSponsorTakedaRan2017 to 2024Enrolled454ConditionsMyelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, AcuteArmsAzacitidine, Pevonedistat
3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 114 citations in OpenAlex.

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  16. Therapy of high-risk myelodysplastic syndromes.Bone marrow transplantation · 2026
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21 more citing papers are in PubMed but not listed here.

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

19 authors at 16 institutions in 9 countries.

Lionel AdèsINSERM U944, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint Louis and University of Paris, Paris, France.ORCID 0000-0002-9020-8766
Larisa GirshovaFederal Almazov North-West Medical Research Centre, Saint-Petersburg, Russia.ORCID 0000-0002-0559-9556
Vadim A DoroninCity Clinical Hospital 40, Moscow, Russia.
María Díez-CampeloInstitute for Biomedical Research of Salamanca (IBSAL), University Hospital of Salamanca, Salamanca, Spain.ORCID 0000-0002-1467-6779
David ValcárcelHematology Department, Vall Hebron Institute of Oncology (VHIO), Vall d'Hebron, University Hospital, Barcelona, Spain.
Suman KambhampatiSarah Cannon at Research Medical Center, Kansas City, MO.
Nora-Athina ViniouHematology Unit, First, Department of Internal Medicine, Laikon General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Dariusz WoszczykUniversity of Opole, Provincial Hospital, Opole, Poland.
Raquel De Paz AriasHematology, Hospital Universitario La Paz-IDIPaz, Madrid, Spain.
Argiris SymeonidisHematology Division, Department of Internal Medicine, University Hospital Patras, Patras, Greece.ORCID 0000-0002-3685-3473
Achilles AnagnostopoulosHematology Department, General Hospital "George Papanikolaou," Thessaloniki, Greece.ORCID 0000-0003-4384-9031
Eduardo Ciliao MunhozHematology and Oncology Clinic, Erasto Gaertner Hospital, Curitiba, Brazil.
Uwe PlatzbeckerDepartment of Hematology and Cellular Therapy, Leipzig University Hospital, Leipzig, Germany.ORCID 0000-0003-1863-3239
Valeria SantiniMDS (Myelodysplastic Syndrome) Unit, Hematology, Azienda Ospedaliero-Universitaria (AOU) Careggi, University of Florence, Florence, Italy.ORCID 0000-0002-5439-2172
Robert J FramTakeda Development Center Americas, Inc (TDCA), Lexington, MA; and.
Ying YuanTakeda Development Center Americas, Inc (TDCA), Lexington, MA; and.
Sharon FriedlanderTakeda Development Center Americas, Inc (TDCA), Lexington, MA; and.
Douglas V FallerTakeda Development Center Americas, Inc (TDCA), Lexington, MA; and.
Mikkael A SekeresDivision of Hematology, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL.
Takeda (United States) · USAzienda Ospedaliero-Universitaria Careggi · ITCity Clinical Hospital · RUFederal Almazov North-West Medical Research Centre · RUGeneral University Hospital of Patras · GRG. Papanikolaou General Hospital · GRHospital Erasto Gaertner · BRHospital Universitario La Paz · ESInserm · FRInstituto de Investigación Biomédica de Salamanca · ESNational and Kapodistrian University of Athens · GRResearch Medical Center · USUniversity Hospital Leipzig · DEUniversity of Miami · USUniversity of Opole · PLVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PANTHER is a global, randomized phase 3 trial of pevonedistat+azacitidine (n = 227) vs azacitidine monotherapy (n = 227) in patients with newly diagnosed higher-risk myelodysplastic syndromes (MDS; n = 324), higher-risk chronic myelomonocytic leukemia (n = 27), or acute myeloid leukemia (AML) with 20% to 30% blasts (n = 103). The primary end point was event-free survival (EFS). In the intent-to-treat population, the median EFS was 17.7 months with pevonedistat+azacitidine vs 15.7 months with azacitidine (hazard ratio [HR], 0.968; 95% confidence interval [CI], 0.757-1.238; P = .557) and in the higher-risk MDS cohort, median EFS was 19.2 vs 15.6 months (HR, 0.887; 95% CI, 0.659-1.193; P = .431). Median overall survival (OS) in the higher-risk MDS cohort was 21.6 vs 17.5 months (HR, 0.785; P = .092), and in patients with AML with 20% to 30% blasts was 14.5 vs 14.7 months (HR, 1.107; P = .664). In a post hoc analysis, median OS in the higher-risk MDS cohort for patients receiving >3 cycles was 23.8 vs 20.6 months (P = .021) and for >6 cycles was 27.1 vs 22.5 months (P = .008). No new safety signals were identified, and the azacitidine dose intensity was maintained. Common hematologic grade ≥3 treatment emergent adverse events were anemia (33% vs 34%), neutropenia (31% vs 33%), and thrombocytopenia (30% vs 30%). These results underscore the importance of large, randomized controlled trials in these heterogeneous myeloid diseases and the value of continuing therapy for >3 cycles. The trial was registered on clinicaltrials.gov as #NCT03268954.

Indexed as

Leukemia, Myelomonocytic, ChronicAntimetabolites, AntineoplasticAzacitidineCyclopentanesDrug Therapy, CombinationHumansPyrimidinesAntimetabolites, AntineoplasticAzacitidineCyclopentanespevonedistatPyrimidines

Identifiers

PMID35728048
PMCPMC9631625
OpenAlexW4283264931

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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 OpenQuestion graph.