Evidence map›Paper›PMID 24092933›Full record

Trial reportBlood2013

A phase 2 trial of azacitidine and gemtuzumab ozogamicin therapy in older patients with acute myeloid leukemia.

Sucha Nand, Megan Othus, John E Godwin, Cheryl L Willman, Thomas H Norwood, Dianna S Howard, Steven E Coutre, Harry P Erba, Frederick R Appelbaum

Abstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Blood, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 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

34 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Bias in Mean Survival From Fitting Cure Models With Limited Follow-Up.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2020
    Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. 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

9 authors.

Sucha NandDepartment of Medicine, Loyola University Medical Center, Maywood, IL;
Megan Othus
John E Godwin
Cheryl L Willman
Thomas H Norwood
Dianna S Howard
Steven E Coutre
Harry P Erba
Frederick R Appelbaum

Funding

SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
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
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
GRAND RAPIDS CLINICAL ONCOLOGY PROGRAMU10CA035178 · NCI · SPECTRUM HEALTH HOSPITALS · PI PADULA, GILBERT DARIN ANTHONY · 1985 to 2014
$16.2M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045807 · NCI · VOLUNTARY HOSPITALS OF AMERICA-ILLINOIS · PI WADE, JAMES L · 1987 to 2014
$16.0M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035261 · NCI · GRANT/RIVERSIDE METHODIST HOSPITALS · PI KUEBLER, PHILIP J. · 1985 to 2014
$10.6M
WESTERN ONCOLOGY RESEARCH CONSORTIUMU10CA045377 · NCI · PROVIDENCE PORTLAND MEDICAL CENTER · PI CONLIN, ALISON K · 1987 to 2013
$9.9M
NM MINORITY-BASED COMMUNITY CLINICAL ONC. PROGRAMU10CA086780 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI ROYCE, MELANIE E · 2000 to 2014
$8.8M
KANSAS CITY COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035176 · NCI · NCI COMMUNITY ONCOLOGY RESEARCH PROGRAM · PI GAUR, RAKESH · 1985 to 2014
$8.0M
Montana Cancer Consortium CCOPU10CA067575 · NCI · MONTANA CANCER CONSORTIUM · PI MARCHELLO, BENJAMIN T. · 1995 to 2013
$6.5M
NCI NIH HHS CA11083NCI NIH HHS CA12644NCI NIH HHS CA14028NCI NIH HHS CA16385NCI NIH HHS CA35261NCI NIH HHS CA45377NCI NIH HHS CA45808NCI NIH HHS CA46136NCI NIH HHS CA46282NCI NIH HHS CA58882NCI NIH HHS CA63848NCI NIH HHS CA86780NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035176NCI NIH HHS N01 CA035178NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045807NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA067575NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035176NCI NIH HHS U10 CA035178NCI NIH HHS U10 CA035261NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045807NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA058882NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA086780NCI NIH HHS U10 CA180855
6 · The paper itself

Abstract

This trial tested the safety and efficacy of a regimen consisting of hydroxyurea followed by azacitidine, 75 mg/m(2) for 7 days, and gemtuzumab ozogamicin, 3 mg/m(2) on day 8, in older patients with newly diagnosed acute myeloid leukemia. Those achieving a complete remission received 1 consolidation treatment followed by 4 cycles of azacitidine. The patients were stratified into good-risk (age 60-69 years or performance status 0-1) and poor-risk (age ≥70 years and performance status 2 or 3) groups. Specific efficacy and safety goals were defined as being supportive of further study of the regimen. Eighty-three patients were registered in the good-risk cohort and 59 in poor-risk cohort, with median age of 71 and 75 years, respectively. In the good-risk group, 35 patients (44%) achieved a complete remission. Median relapse-free and overall survivals were 8 and 11 months, respectively. Six patients (8%) died within 30 days of registration. In the poor-risk group, 19 (35%) achieved a complete remission. Median relapse-free and overall survivals were 7 and 11 months, respectively. Seven patients (14%) died early. The results of this trial met predefined goals for efficacy and safety for the poor-risk cohort but not the good-risk group. .

Indexed as

AgedAged, 80 and overAge FactorsAminoglycosidesAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAzacitidineDisease-Free SurvivalFemaleGemtuzumabHumansHydroxyureaKaplan-Meier EstimateKarnofsky Performance StatusLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteAminoglycosidesAntibodies, Monoclonal, HumanizedAzacitidineGemtuzumabHydroxyurea

Identifiers

PMID24092933
PMCPMC3829116

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.