Evidence map›Paper›PMID 22733022›Full record

Trial reportHaematologica2012

Randomized phase II study of two schedules of flavopiridol given as timed sequential therapy with cytosine arabinoside and mitoxantrone for adults with newly diagnosed, poor-risk acute myelogenous leukemia.

Judith E Karp, Elizabeth Garrett-Mayer, Elihu H Estey, Michelle A Rudek, B Douglas Smith, Jacqueline M Greer, D Michelle Drye, Karen Mackey, Kathleen Shannon Dorcy, Steven D Gore and 10 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
3.3field-weighted citation impact, top 7% 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

40 citing papers in PubMed, 61 citations in OpenAlex.

  1. Trial
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  8. Article
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  10. Article
  11. A preclinical platform for assessing antitumor effects and systemic toxicities of cancer drug targets.Proceedings of the National Academy of Sciences of the United States of America · 2022
    Article
  12. Small molecule inhibitors of cyclin-dependent kinase 9 for cancer therapy.Journal of enzyme inhibition and medicinal chemistry · 2021
    Review
  13. Review
  14. Cutting Edge Molecular Therapy for Acute Myeloid Leukemia.International journal of molecular sciences · 2020
    Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Heterogeneity in refractory acute myeloid leukemia.Proceedings of the National Academy of Sciences of the United States of America · 2019
    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

20 authors at 5 institutions in 1 country.

Judith E KarpDivision of Hematologic Malignancies, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland 21231-1000, USA. jkarp2@jhmi.edu
Elizabeth Garrett-Mayer
Elihu H Estey
Michelle A Rudek
B Douglas Smith
Jacqueline M Greer
D Michelle Drye
Karen Mackey
Kathleen Shannon Dorcy
Steven D Gore
Mark J Levis
Michael A McDevitt
Hetty E Carraway
Keith W Pratz
Douglas E Gladstone
Margaret M Showel
Megan Othus
L Austin Doyle
John J Wright
John M Pagel
Sidney Kimmel Comprehensive Cancer Center · USFred Hutch Cancer Center · USNational Cancer Institute · USUniversity of Washington · USMedical University of South Carolina · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
Institute for Clinical and Translational Research (UL1)UL1RR025005 · NCRR · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2007 to 2011
$75.8M
PHASE I TRIALS OF ANTICANCER AGENTSU01CA070095 · NCI · JOHNS HOPKINS UNIVERSITY · PI CARDUCCI, MICHAEL A · 1995 to 2013
$8.6M
NCI NIH HHS 2P30CA06973-46NCI NIH HHS P30 CA006973NCI NIH HHS U01 CA070095NCI NIH HHS U01 CA70095NCRR NIH HHS UL1 RR025005NCRR NIH HHS UL1RR025005
6 · The paper itself

Abstract

backgroundFlavopiridol is a protein-bound, cytotoxic, cyclin dependent kinase inhibitor. A phase II trial of flavopiridol followed by ara-C and mitoxantrone with flavopiridol given by 1-h bolus for adults with newly-diagnosed, poor-risk acute myelogenous leukemia yielded 67% complete remission with median disease-free survival of 13.6 months. DESIGN AND

methodsWe compared bolus flavopiridol (50 mg/m(2)/day, Arm A) versus 'hybrid' flavopiridol (30 mg/m(2) over 30 min followed by 40 mg/m(2) over 4 h, Arm B) followed by ara-C and mitoxantrone in 78 patients (39 per arm) with newly diagnosed, poor-risk acute myelogenous leukemia. To mitigate imbalance, patients were stratified by presence or absence of secondary leukemia and therapy for antecedent disorder.

resultsDeath at or before Day 60 occurred in 8% of patients per arm. Complete remission plus complete remission with incomplete recovery was 68% (Arm A, 62%; Arm B, 74%) overall, and 65% or over in both arms for patients with secondary leukemia and leukemia with adverse genetics. In Arm A 91% and in Arm B 86% of patients received chemotherapy and/or allogeneic transplantation in complete remission. Median overall survival for all remission patients has not been reached for either arm, with median disease free survival of 13.6 months for Arm A and of 12.0 months for Arm B.

conclusionsBoth flavopiridol schedules produce comparably encouraging results in adults with poor-risk acute myelogenous leukemia. Given the greater ease of bolus administration, we are conducting a randomized phase II study of bolus flavopiridol followed by ara-c and mitoxantrone versus conventional induction therapy for patients aged 70 years and under with intermediate or poor-risk acute myelogenous leukemia. This study is registered at www.clinicaltrials.gov as #NCT 00407966.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCytarabineDisease-Free SurvivalFemaleFlavonoidsHumansLeukemia, Myeloid, AcuteMaleMiddle AgedMitoxantronePiperidinesSurvival RatealvocidibCytarabineFlavonoidsMitoxantronePiperidines

Identifiers

PMID22733022
PMCPMC3487449
OpenAlexW1990453662

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.