Evidence map›Paper›PMID 35697729›Full record

Trial reportScientific reports2022

Adjunction of a fish oil emulsion to cytarabine and daunorubicin induction chemotherapy in high-risk AML.

Emmanuel Gyan, Arnaud Pigneux, Mathilde Hunault, Pierre Peterlin, Martin Carré, Jacques-Olivier Bay, Caroline Bonmati, Maria-Pilar Gallego-Hernanz, Bruno Lioure, Philippe Bertrand and 7 more

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

Trial report in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01999413 (Pilot Study of the Efficacy and Tolerance of the Adjunction of a Fish Oil Emulsion to Daunorubicin and Cytarabine Chemotherapy for the Treatment of Acute MYeloblastic Leukemia of Younger Patients With High-risk Cytogenetics), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 34% 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.

NCT01999413 phase2completednot on this map

Pilot Study of the Efficacy and Tolerance of the Adjunction of a Fish Oil Emulsion to Daunorubicin and Cytarabine Chemotherapy for the Treatment of Acute MYeloblastic Leukemia of Younger Patients With High-risk Cytogenetics

TypeinterventionalSponsorFrench Innovative Leukemia OrganisationRan2013 to 2018Enrolled30ConditionsAcute Myeloid Leukemia (AML)ArmsOMEGAVEN, Daunorubicin, Cytarabine
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
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

17 authors at 11 institutions in 1 country.

Emmanuel GyanService d'Hématologie et Thérapie Cellulaire, Centre Hospitalier Universitaire de Tours, Hôpital Bretonneau, Bâtiment Kaplan, 2, boulevard Tonnellé, 37044, Tours Cedex 09, France. emmanuel.gyan@univ-tours.fr.
Arnaud PigneuxClinique d'Hématologie, Université de Bordeaux, Hôpital Haut-Levêque, Pessac, France.
Mathilde HunaultService des Maladies du Sang, FHU GOAL, CRCINA, INSERM Angers, Centre Hospitalier Universitaire, Tours, France.
Pierre PeterlinService d'Hématologie, Centre Hospitalier Universitaire, Nantes, France.
Martin CarréService d'Hématologie, Centre Hospitalier Universitaire, Grenoble, France.
Jacques-Olivier BayService d'Hématologie, Centre Hospitalier Universitaire, Clermont-Ferrand, France.
Caroline BonmatiService d'Hématologie, Centre Hospitalier Universitaire, Nancy, France.
Maria-Pilar Gallego-HernanzService d'Hématologie, Centre Hospitalier Universitaire, Poitiers, France.
Bruno LioureService d'Hématologie, Centre Hospitalier Universitaire, Strasbourg, France.
Philippe BertrandLaboratoire de Biostatistiques, Faculté de Médecine, Université de Tours, Tours, France.
Nicolas ValletService d'Hématologie et Thérapie Cellulaire, Centre Hospitalier Universitaire de Tours, Hôpital Bretonneau, Bâtiment Kaplan, 2, boulevard Tonnellé, 37044, Tours Cedex 09, France.
David TernantLaboratoire de Pharmacologie-Toxicologie, Centre Hospitalier Universitaire, Tours, France.
François DarrouzainLaboratoire d'Hématologie, Centre Hospitalier Universitaire, Nantes, France.
Frédéric PicouERL CNRS 7001, Leukemic Niche and Redox Metabolism (LNOx), Faculté de Médecine, Université de Tours, Tours, France.
Marie-Christine BénéLaboratoire d'Hématologie, Centre Hospitalier Universitaire, Nantes, France.
Christian RécherService d'Hématologie, Institut Universitaire de Cancérologie de Toulouse, Toulouse, France.
Olivier HéraultERL CNRS 7001, Leukemic Niche and Redox Metabolism (LNOx), Faculté de Médecine, Université de Tours, Tours, France. olivier.herault@univ-tours.fr.
Centre Hospitalier Universitaire de Nantes · FRCentre Hospitalier Universitaire de Tours · FRUniversité de Tours · FRAdaptation Biologique et VieillissementCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Universitaire de Clermont-Ferrand · FRCentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Poitiers · FRCentre National de la Recherche Scientifique · FRInserm · FRUniversité de Bordeaux · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The treatment of acute myeloid leukemia (AML) with unfavorable cytogenetics treatment remains a challenge. We previously established that ex vivo exposure of AML blasts to eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or fish oil emulsion (FO) induces Nrf2 pathway activation, metabolic switch, and cell death. The FILO group launched a pilot clinical study to evaluate the feasibility, safety, and efficacy of the adjunction of a commercial FO emulsion to 3 + 7 in untreated AML with unfavorable cytogenetics. The primary objective was complete response (CR). Thirty patients were included. FO administration raised the plasma levels of eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids (p < 0.001). The pharmacokinetics of cytarabine and daunorubicin were unaffected. A historical comparison to the LAM2001 trial (Lioure et al. Blood 2012) found a higher frequency of grade 3 serious adverse events, with no drug-related unexpected toxicity. The CR rate was 77%, and the partial response (PR) 10%, not significantly superior to that of the previous study (CR 72%, PR 1%). RT-qPCR analysis of Nrf2 target genes and antioxidant enzymes did not show a significant in vivo response. Overall, FO emulsion adjunction to 3 + 7 is feasible. An improvement in CR was not shown in this cohort of high-risk patients. The present data does not support the use of FO in adjunction with 3 + 7 in high-risk AML patients.ClinicalTrials.gov identifier: NCT01999413.

Indexed as

CytarabineLeukemia, Myeloid, AcuteAntineoplastic Combined Chemotherapy ProtocolsDaunorubicinDocosahexaenoic AcidsEicosapentaenoic AcidEmulsionsFeasibility StudiesFish OilsHumansInduction ChemotherapyNF-E2-Related Factor 2CytarabineDaunorubicinDocosahexaenoic AcidsEicosapentaenoic AcidEmulsionsFish OilsNF-E2-Related Factor 2

Identifiers

PMID35697729
PMCPMC9192636
OpenAlexW4282550241

What OpenQuestion holds

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LicenceCC BY
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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.