Evidence map›Paper›PMID 25689471›Full record

Trial reportAmerican journal of hematology2015

Idarubicin, cytarabine, and pravastatin as induction therapy for untreated acute myeloid leukemia and high-risk myelodysplastic syndrome.

Mazyar Shadman, Raya Mawad, Carol Dean, Tara L Chen, Kathleen Shannon-Dorcy, Vicky Sandhu, Paul C Hendrie, Bart L Scott, Rol B Walter, Pamela S Becker and 2 more

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in American journal of hematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
1.1field-weighted citation impact, top 22% 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

19 citing papers in PubMed, 29 citations in OpenAlex.

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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

12 authors at 3 institutions in 1 country.

Mazyar ShadmanClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Raya MawadSwedish Cancer Institute, Swedish Medical Center, Seattle, Washington.
Carol DeanClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Tara L ChenDepartment of Pharmacy, University of Washington, Seattle, Washington.
Kathleen Shannon-DorcyClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Vicky SandhuClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Paul C HendrieHematology Division, Department of Medicine, University of Washington, Seattle, Washington.
Bart L ScottClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Rol B WalterClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Pamela S BeckerClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
John M PagelSwedish Cancer Institute, Swedish Medical Center, Seattle, Washington.
Elihu H EsteyClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Fred Hutch Cancer Center · USUniversity of Washington · USSwedish Medical Center · US

Funding

RESEARCH TRAINING IN HEMATOLOGYT32HL007093 · NHLBI · UNIVERSITY OF WASHINGTON · PI Janis L Abkowitz · 1985 to 2026
$13.9M
NHLBI NIH HHS 5T32HL007093-38NHLBI NIH HHS T32 HL007093
6 · The paper itself

Abstract

Previous studies suggest that idarubicin/cytarabine(ara-C)/pravastatin (IAP) is an active salvage regimen for patients with AML. We therefore investigated this regimen in patients with newly-diagnosed AML or MDS (≥10% blasts). Patients were eligible if the anticipated treatment-related mortality (TRM) was <10%. Patients received pravastatin (1,280 mg/day po; days 1-8), cytarabine (1.5 g/m(2) /day; days 4-7), and idarubicin (12 mg/m(2) /day, days 4-6). Up to 3 cycles of consolidation with a shortened course was permitted. The primary endpoints were "good CR" rate (CR on day 35 without minimal residual disease) and TRM in the first 28 days. The study was to stop if after each cohort of 5 patients (a) the Bayesian posterior probability was < 5% that the true "good CR rate" was ≥ 70% or (b) the posterior probability was >25% that the TRM rate was ≥5%. Twenty-four patients were included. Conventional CR was achieved in 15 (63%) patients but only 12 (50%) achieved "good CR". 4 of 12 (33%) patients with "good CR" relapsed at median of 16 weeks (10.5-19). Five (21%) patients had refractory disease. Survival probability at 1 year was 72% (48.7-64). Two (8.3%) patients died within 28 days from multiorgan failure. The most common grade 3-4 adverse effects were febrile neutropenia (75%) and diarrhea (25%). Based on the stopping rules accrual ceased after entry of these 24 patients. IAP did not meet the predefined efficacy criteria for success. Therefore, we would not recommend this regimen for phase three testing in this patient subset.

Indexed as

Induction ChemotherapyAdolescentAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCytarabineDisease-Free SurvivalFemaleFollow-Up StudiesHumansIdarubicinLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesPravastatinCytarabineIdarubicinPravastatin

Identifiers

PMID25689471
PMCPMC4803479
OpenAlexW2118796047

What OpenQuestion holds

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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.