Evidence map›Paper›PMID 30545576›Full record

Trial reportThe Lancet. Haematology2019

Treatment with a 5-day versus a 10-day schedule of decitabine in older patients with newly diagnosed acute myeloid leukaemia: a randomised phase 2 trial.

Nicholas J Short, Hagop M Kantarjian, Sanam Loghavi, Xuelin Huang, Wei Qiao, Gautam Borthakur, Tapan M Kadia, Naval Daver, Maro Ohanian, Courtney D Dinardo and 17 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Haematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 3 pooled it
–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

73 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Azacitidine, Venetoclax, and Gilteritinib in Newly Diagnosed and Relapsed or RefractoryJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  9. Trial
  10. Trial
  11. Eprenetapopt Plus Azacitidine inJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Trial
  12. Eprenetapopt (APR-246) and Azacitidine inJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Trial
  13. Trial
  14. Trial
  15. Trial
  16. Article
  17. Article
  18. Long-term outcomes inHaematologica · 2026
    Article
  19. Review
  20. Review

13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors.

Nicholas J ShortDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Hagop M KantarjianDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sanam LoghaviDepartment of Hematopathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Xuelin HuangDepartment of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Wei QiaoDepartment of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Gautam BorthakurDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Tapan M KadiaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Naval DaverDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Maro OhanianDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Courtney D DinardoDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Zeev EstrovDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Rashmi Kanagal-ShamannaDepartment of Hematopathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Abhishek MaitiDivision of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Christopher B BentonDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Prithviraj BoseDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Yesid AlvaradoDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Elias JabbourDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Steven M KornblauDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Naveen PemmarajuDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nitin JainDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Yvonne GasiorDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Mary Ann RichieDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sherry PierceDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jorge CortesDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Marina KonoplevaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Guillermo Garcia-ManeroDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Farhad RavandiDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: fravandi@mdanderson.org.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Paul Calabresi Clinical Oncology AwardK12CA088084 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI David S. Hong, Scott Kopetz · 2000 to 2026
$14.0M
NCI NIH HHS K12 CA088084NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundHypomethylating agents, such as decitabine, are the standard of care for older patients with newly diagnosed acute myeloid leukaemia. Single-arm studies have suggested that a 10-day schedule of decitabine cycles leads to better outcomes than the usual 5-day schedule. We compared the efficacy and safety of these two schedules.

methodsEligible patients were aged 60 years or older with acute myeloid leukaemia but unsuitable for intensive chemotherapy (or <60 years if unsuitable for intensive chemotherapy with an anthracycline plus cytarabine). The first 40 patients were allocated equally to the two treatment groups by computer-generated block randomisation (block size 40), after which a response-adaptive randomisation algorithm used all previous patients' treatment and response data to decide the allocation of each following patient favouring the group with superior response. Patients were assigned to receive 20 mg/m

findingsBetween Feb 28, 2013, and April 12, 2018, 71 patients were enrolled. 28 received decitabine for 5 days and 43 for 10 days, and all were assessable for efficacy and safety. The primary endpoint was achieved in similar proportions of patients in the two treatment groups (12 [43%] of 28 in the 5-day schedule group, 95% credible interval 26-60, and 17 [40%] of 43 in the 10-day schedule group, 26-54, p=0·78; difference 3%, -21 to 27). Total follow-up was 38·2 months, during which the median duration of overall survival was 5·5 months (IQR 2·1-11·7) in the 5-day group and 6·0 months (1·9-11·7) in the 10-day group. 1-year overall survival was 25% in both groups. Complete remission, CRp, CRi, and overall survival did not differ between groups when stratified by cytogenetics, de-novo versus secondary or therapy-related acute myeloid leukaemia, or TP53

interpretationIn older patients with newly diagnosed acute myeloid leukaemia, efficacy and safety did not differ by the 5-day or the 10-day decitabine schedule.

fundingUniversity of Texas MD Anderson Cancer Center and National Cancer Institute Specialized Programs of Research Excellence.

Indexed as

Antimetabolites, AntineoplasticDecitabineFemaleHumansLeukemia, Myeloid, AcuteMaleMiddle AgedTreatment OutcomeAntimetabolites, AntineoplasticDecitabine

Identifiers

PMID30545576
PMCPMC6563344

What OpenQuestion holds

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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.