Evidence map›Paper›PMID 24528179›Full record

Trial reportBritish journal of haematology2014

Arsenic trioxide during consolidation for patients with previously untreated low/intermediate risk acute promyelocytic leukaemia may eliminate the need for maintenance therapy.

Steven E Coutre, Megan Othus, Bayard Powell, Cheryl L Willman, Wendy Stock, Elisabeth Paietta, Denise Levitan, Meir Wetzler, Eyal C Attar, Jessica K Altman and 6 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00492856 (S0521, A Randomized Trial of Maintenance Versus Observation for Patients With Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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.

NCT00492856 phase3completednot on this map

S0521, A Randomized Trial of Maintenance Versus Observation for Patients With Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2007 to 2016Enrolled105ConditionsLeukemiaArmsmercaptopurine, methotrexate, tretinoin
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Epidemiology of de novo Acute Myeloid Leukemia in Kuwait per the 2016 WHO Classification.Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2022
    Article
  5. Review
  6. Review
  7. Article
  8. Acute Promyelocytic Leukemia: A Summary.Journal of the advanced practitioner in oncology · 2018
    Review
  9. [How I treat PML-RARα positive actue promyelocytic leukemia].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2018
    Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. 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

16 authors.

Steven E CoutreStanford University School of Medicine, Stanford, CA, USA.
Megan Othus
Bayard Powell
Cheryl L Willman
Wendy Stock
Elisabeth Paietta
Denise Levitan
Meir Wetzler
Eyal C Attar
Jessica K Altman
Steven D Gore
Tracy Maher
Kenneth J Kopecky
Martin S Tallman
Richard A Larson
Frederick R Appelbaum

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
Foreign Accrual - ECOGU10CA037403 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2014
$34.6M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045807 · NCI · VOLUNTARY HOSPITALS OF AMERICA-ILLINOIS · PI WADE, JAMES L · 1987 to 2014
$16.0M
ECOG Specimen BankingU24CA114737 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI COMIS, ROBERT L · 2005 to 2014
$9.3M
NM MINORITY-BASED COMMUNITY CLINICAL ONC. PROGRAMU10CA086780 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI ROYCE, MELANIE E · 2000 to 2014
$8.8M
NCI NIH HHS CA11083NCI NIH HHS CA14028NCI NIH HHS CA16116NCI NIH HHS CA17145NCI NIH HHS CA20319NCI NIH HHS CA21115NCI NIH HHS CA31946NCI NIH HHS CA41287NCI NIH HHS CA45808NCI NIH HHS CA46282NCI NIH HHS CA58861NCI NIH HHS CA76132NCI NIH HHS CA86780NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045807NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA017145NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA037403NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA041287NCI NIH HHS U10 CA045807NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA058861NCI NIH HHS U10 CA086780NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA114737
6 · The paper itself

Abstract

Aa total of 105 patients (age ≥18 years) with newly diagnosed low or intermediate risk acute promyelocytic leukaemia (APL) were treated with a standard induction and consolidation regimen including arsenic trioxide (ATO). Sixty-eight patients who were polymerase chain reaction (PCR) negative for PML-RARA post-consolidation were randomized to either 1 year of maintenance with tretinoin, mercaptopurine and methotrexate, or observation. Enrollment in this non-inferiority trial was stopped prematurely due to slow accrual. With a median follow up of 36·1 months, the overall survival of the 105 patients was 93%, and there have been no relapses in the patients randomized to maintenance or observation. These results demonstrate that cures can be expected in >90% of patients with low and intermediate risk APL and suggest that maintenance therapy may not be needed if patients are treated with an intensive post-remission regimen including ATO. This trial was registered at clinicaltrials.gov as #NCT00492856.

Indexed as

Consolidation ChemotherapyAdultAgedAminoglycosidesAnimalsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsArsenicalsArsenic TrioxideBiomarkers, TumorCytarabineDaunorubicinDisease-Free SurvivalDogsFemaleGemtuzumabAminoglycosidesAntibodies, Monoclonal, HumanizedArsenicalsArsenic TrioxideBiomarkers, TumorCytarabineDaunorubicinGemtuzumabMercaptopurineMethotrexateOncogene Proteins, FusionOxidespromyelocytic leukemia-retinoic acid receptor alpha fusion oncoproteinTretinoinacute promyelocytic leukaemialeukaemia clinicalleukaemia trialsmalignant haematology

Identifiers

PMID24528179
PMCPMC4064464

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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.