Evidence map›Paper›PMID 22585696›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2012

Phase II trial of vorinostat with idarubicin and cytarabine for patients with newly diagnosed acute myelogenous leukemia or myelodysplastic syndrome.

Guillermo Garcia-Manero, Francesco Paolo Tambaro, Nebiyou B Bekele, Hui Yang, Farhad Ravandi, Elias Jabbour, Gautam Borthakur, Tapan M Kadia, Marina Y Konopleva, Stefan Faderl and 8 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 90 papers.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed
10.6field-weighted citation impact, top 1% 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

90 citing papers in PubMed, 164 citations in OpenAlex.

  1. Trial
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  8. Epigenetic Targeting in Myeloid Malignancies.Advances in experimental medicine and biology · 2026
    Review
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  10. Review
  11. Article
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  16. Epigenetic reprogramming in cancer: From diagnosis to treatment.Frontiers in cell and developmental biology · 2023
    Review
  17. Review
  18. Article
  19. Article
  20. Article

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

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

18 authors at 2 institutions in 1 country.

Guillermo Garcia-ManeroDepartment of Leukemia, University of Texas, MD Anderson Cancer Center, 1515 Holcombe Blvd, Box 428, Houston, TX 77025, USA. ggarciam@mdanderson.org
Francesco Paolo Tambaro
Nebiyou B Bekele
Hui Yang
Farhad Ravandi
Elias Jabbour
Gautam Borthakur
Tapan M Kadia
Marina Y Konopleva
Stefan Faderl
Jorge E Cortes
Mark Brandt
Yumin Hu
Deborah McCue
Willie Mae Newsome
Sherry R Pierce
Marcos de Lima
Hagop M Kantarjian
The University of Texas MD Anderson Cancer Center · USState Key Laboratory of Oncology in South China

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeTo evaluate the safety and efficacy of the combination of the histone deacetylase inhibitor vorinostat with idarubicin and ara-C (cytarabine) in patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS). PATIENTS AND

methodsPatients with previously untreated AML or higher-risk MDS age 15 to 65 years with appropriate organ function and no core-binding factor abnormality were candidates. Induction therapy was vorinostat 500 mg orally three times a day (days 1 to 3), idarubin 12 mg/m(2) intravenously (IV) daily × 3 (days 4 to 6), and cytarabine 1.5 g/m(2) IV as a continuous infusion daily for 3 or 4 days (days 4 to 7). Patients in remission could be treated with five cycles of consolidation therapy and up to 12 months of maintenance therapy with single-agent vorinostat. The study was designed to stop early if either excess toxicity or low probability of median event-free survival (EFS) of more than 28 weeks was likely.

resultsAfter a three-patient run-in phase, 75 patients were treated. Median age was 52 years (range, 19 to 65 years), 29 patients (39%) were cytogenetically normal, and 11 (15%) had FLT-3 internal tandem duplication (ITD). No excess vorinostat-related toxicity was observed. Induction mortality was 4%. EFS was 47 weeks (range, 3 to 134 weeks), and overall survival was 82 weeks (range, 3 to 134 weeks). Overall response rate (ORR) was 85%, including 76% complete response (CR) and 9% in CR with incomplete platelet recovery. ORR was 93% in diploid patients and 100% in FLT-3 ITD patients. Levels of NRF2 and CYBB were associated with longer survival.

conclusionThe combination of vorinostat with idarubicin and cytarabine is safe and active in AML.

Indexed as

AdolescentAdultAgedAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalFemaleHumansHydroxamic AcidsIdarubicinLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesRecurrenceVorinostatHydroxamic AcidsIdarubicinVorinostat

Identifiers

PMID22585696
PMCPMC4879705
OpenAlexW2141865164

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.