Evidence map›Paper›PMID 24075534›Full record

ArticleLeukemia research2013

A phase I study using bortezomib with weekly idarubicin for treatment of elderly patients with acute myeloid leukemia.

Dianna S Howard, Jane Liesveld, Gordon L Phillips, John Hayslip, Heidi Weiss, Craig T Jordan, Monica L Guzman

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Leukemia research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00382954 (A Phase I Study Using Bortezomib), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing 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.

NCT00382954 phase1completednot on this map

A Phase I Study Using Bortezomib (Velcade, Formerly Known as PS-341) With Weekly Idarubicin for the Treatment of Elderly (>/= 60 Years) and Relapsed Patients With Acute Myelogenous Leukemia

TypeinterventionalSponsorUniversity of KentuckyRan2004 to 2008Enrolled55ConditionsAcute Myelogenous LeukemiaArmsVelcade, Idarubicin
3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. The dual role of autophagy in acute myeloid leukemia.Journal of hematology & oncology · 2022
    Review
  5. Regulation of Nuclear Factor-kappaB Function byFrontiers in cell and developmental biology · 2021
    Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. The role of the proteasome in AML.Blood cancer journal · 2016
    Review
  12. Article
  13. Bortezomib and Arsenic Trioxide Activity on a Myelodysplastic Cell Line (P39): A Gene Expression Study.Turkish journal of haematology : official journal of Turkish Society of Haematology · 2015
    Article
  14. Review
  15. Review
  16. Article
  17. 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

7 authors.

Dianna S HowardMarkey Cancer Center, University of Kentucky, Lexington, KY, United States. Electronic address: DSHowa0@uky.edu.
Jane Liesveld
Gordon L Phillips
John Hayslip
Heidi Weiss
Craig T Jordan
Monica L Guzman

Funding

Selection of Novel Therapies to Ablate Chemoresistant Myeloid Leukemia Stem CellDP2OD007399 · OD · WEILL MEDICAL COLL OF CORNELL UNIV · PI GUZMAN, MONICA L · 2010 to 2010
$2.5M
Bortezomib and Idarubicin in the Treatment of AMLR21CA108162 · NCI · UNIVERSITY OF KENTUCKY · PI HOWARD, DIANNA S · 2004 to 2005
$498k
NCI NIH HHS R21 CA108162NCI NIH HHS R21 CA108162-01A1NIH HHS DP2 OD007399
6 · The paper itself

Abstract

We report the results of a phase I study with four dose levels of bortezomib in combination with idarubicin. Eligible patients were newly diagnosed with acute myeloid leukemia (AML) age ≥60 years, or any adult with relapsed AML. Bortezomib was given twice weekly at 0.8, 1.0, or 1.2 mg/m(2) with once weekly idarubicin 10 mg/m(2) for four weeks. Twenty patients were treated: 13 newly diagnosed (median age 68, range 61-83) and 7 relapsed (median age 58, range 40-77). Prior myelodysplastic syndrome (MDS) was documented in 10/13 (77%) newly diagnosed and 1/7 (14%) relapsed patients; the three newly diagnosed patients without prior MDS had dyspoietic morphology. Two dose-limiting toxicities occurred at the initial dose level (bortezomib 0.8 mg/m(2) and idarubicin 10 mg/m(2)); idarubicin was reduced to 8 mg/m(2) without observing subsequent dose-limiting toxicities. The maximum tolerated dose in this study was bortezomib 1.2 mg/m(2) and idarubicin 8 mg/m(2). Common adverse events included: neutropenic fever, infections, constitutional symptoms, and gastrointestinal symptoms. No subjects experienced neurotoxicity. Most patients demonstrated hematologic response as evidenced by decreased circulating blasts. Four patients (20%) achieved complete remission. There was one treatment-related death. The combination of bortezomib and idarubicin in this mostly poor-risk, older AML group was well tolerated and did not result in high mortality. This trial was registered at www.clinicaltrials.gov as #NCT00382954.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibFemaleFollow-Up StudiesHumansIdarubicinLeukemia, Myeloid, AcuteMaleMaximum Tolerated DoseMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingBoronic AcidsBortezomibIdarubicinPyrazinesacute myeloid leukemiaAcute myeloid leukemiaAMLBortezomibData Safety Monitoring CommitteeDLTdose-limiting toxicityDSMCElderlyelectrophoretic mobility shift assayEMSAFACSfluorescence-activated cell sortingIdarubiciniKBainhibitor of NF-kBleukemic stem cellLSCmaximum tolerated doseMDSMTDmyelodysplastic syndromeNF-kBnuclear factor kappa B

Identifiers

PMID24075534
PMCPMC4025941

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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.