Evidence map›Paper›PMID 34427990›Full record

ArticleCancer medicine2021

Improved survival with enasidenib versus standard of care in relapsed/refractory acute myeloid leukemia associated with IDH2 mutations using historical data and propensity score matching analysis.

Stéphane de Botton, Joseph M Brandwein, Andrew H Wei, Arnaud Pigneux, Bruno Quesnel, Xavier Thomas, Ollivier Legrand, Christian Recher, Sylvain Chantepie, Mathilde Hunault-Berger and 11 more

Open access · goldAbstract readComparative Study
In one paragraph

Article in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.5field-weighted citation impact, top 17% 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.

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

10 citing papers in PubMed, 15 citations in OpenAlex.

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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

21 authors at 17 institutions in 5 countries.

Stéphane de BottonDepartement d'hematologie, Institut Gustave Roussy, Villejuif, France.ORCID 0000-0002-8126-4942
Joseph M BrandweinUniversity of Alberta, Edmonton, Alberta, Canada.ORCID 0000-0001-9095-8789
Andrew H WeiAlfred Hospital and Monash University, Melbourne, Australia.
Arnaud PigneuxCHU Bordeaux, Hôpital du Haut Lévêque, Bordeaux, France.
Bruno QuesnelCHU Lille, Lille, France.
Xavier ThomasCentre Hospitalier Lyon Sud, Pierre Bénite, France.
Ollivier LegrandAPHP, Hôpital Saint-Antoine, Paris, France.
Christian RecherCHU de Toulouse, Université de Toulouse III Paul Sabatier, Toulouse, France.
Sylvain ChantepieCHU de Caen, Caen, France.
Mathilde Hunault-BergerCHU Angers, Angers, France.
Nicolas BoisselHôpital Saint-Louis, Paris, France.
Salem A NehmeCelgene International, a Bristol Myers Squibb Company, Boudry, Switzerland.
Mark G FrattiniBristol Myers Squibb, Summit, New Jersey, USA.
Alessandra TosoliniBristol Myers Squibb, Summit, New Jersey, USA.
Roland Marion-GalloisBristol Myers Squibb, Summit, New Jersey, USA.
Jixian J WangBristol Myers Squibb, Summit, New Jersey, USA.
Chris CameronCornerstone Research Group, Burlington, Ontario, Canada.
Muhaimen SiddiquiCornerstone Research Group, Burlington, Ontario, Canada.
Brian HuttonOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Gary MilkovichRJM Group LLC, Crown Point, Indiana, USA.
Eytan M SteinMemorial Sloan Kettering Cancer Center, New York, New York, USA.
Bristol-Myers Squibb (United States) · USCornerstone Research Group (United States) · USBristol-Myers Squibb (France) · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Caen Normandie · FRCentre Hospitalier Universitaire de Lille · FRHôpital Cardiologique du Haut-Lévêque · FRHôpital Lyon Sud · FRHôpital Saint-Louis · FRInnovative Energy Solution (United States) · USInstitut Gustave Roussy · FRMemorial Sloan Kettering Cancer Center · USMonash University · AUOttawa Hospital · CASorbonne Université · FRUniversité Toulouse III - Paul Sabatier · FRUniversity of Alberta · CA

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Bristol Myers SquibbNCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe present study evaluated the relative survival benefits associated with enasidenib and current standard of care (SoC) therapies for patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and an isocitrate dehydrogenase 2 (IDH2) mutation who are ineligible for hematopoietic stem cell transplantation (HSCT).

methodsPropensity score matching (PSM) analysis compared survival outcomes observed with enasidenib 100 mg daily in the phase I/II AG221-C-001 trial and SoC outcomes obtained from a real-world chart review of patients in France.

resultsBefore matching, enasidenib (n = 195) was associated with numerically improved overall survival (OS) relative to SoC (n = 80; hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.61-1.11). After matching and adjusting for covariates (n = 78 per group), mortality risk was significantly lower with enasidenib than with SoC (HR, 0.67; 95% CI, 0.47-0.97). The median OS was 9.26 months for enasidenib (95% CI, 7.72-13.24) and 4.76 months for SoC (95% CI, 3.81-8.21). Results remained robust across all sensitivity analyses conducted.

conclusionsPSM analyses indicate that enasidenib significantly prolongs survival relative to SoC among patients with R/R AML and an IDH2 mutation who are ineligible for HSCT. Future prospective studies are needed to validate these findings using other data sources and to assess the comparative efficacy of enasidenib for other treatment outcomes.

Indexed as

AdolescentAdultAgedAminopyridinesClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDrug Resistance, NeoplasmFemaleFranceHumansIsocitrate DehydrogenaseKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaleMiddle AgedMulticenter Studies as TopicAminopyridinesenasidenibIDH2 protein, humanIsocitrate DehydrogenaseTriazinesacute myeloid leukemiaenasidenibIDH2 mutationsoverall survivalstandard of care

Identifiers

PMID34427990
PMCPMC8446562
OpenAlexW3195012238

What OpenQuestion 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 OpenQuestion graph.