Evidence map›Paper›PMID 20960519›Full record

Trial reportCancer2011

A phase 1-2 study of a farnesyltransferase inhibitor, tipifarnib, combined with idarubicin and cytarabine for patients with newly diagnosed acute myeloid leukemia and high-risk myelodysplastic syndrome.

Elias Jabbour, Hagop Kantarjian, Farhad Ravandi, Guillermo Garcia-Manero, Zeev Estrov, Srdan Verstovsek, Susan O'Brien, Stefan Faderl, Deborah A Thomas, John J Wright and 1 more

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.4field-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

24 citing papers in PubMed, 43 citations in OpenAlex.

  1. Phase II trial of vorinostat with idarubicin and cytarabine for patients with newly diagnosed acute myelogenous leukemia or myelodysplastic syndrome.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2012
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  11. Translational medicine @ UniSa · 2016
    Article
  12. Review
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  14. Chronic myelomonocytic leukemia: Forefront of the field in 2015.Critical reviews in oncology/hematology · 2015
    Review
  15. Review
  16. Review
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  18. Article
  19. Article
  20. Targeting the RAS oncogene.Expert opinion on therapeutic targets · 2013
    Review
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

11 authors at 1 institution in 1 country.

Elias JabbourDepartment of Leukemia, The University of Texas, M. D. Anderson Cancer Center, Houston, Texas 77030, USA.
Hagop Kantarjian
Farhad Ravandi
Guillermo Garcia-Manero
Zeev Estrov
Srdan Verstovsek
Susan O'Brien
Stefan Faderl
Deborah A Thomas
John J Wright
Jorge Cortes
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
THE THERAPY OF AMLP01CA055164 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI THOMAS, MATTIE J · 1992 to 2011
$25.3M
NCI NIH HHS P01 CA055164NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundThe authors conducted a phase 1/2 study of tipifarnib in combination with idarubicin and cytarabine (IA) in 95 patients with previously untreated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome.

methodsInduction consisted of idarubicin 12 mg/m(2) a day on days 1-3, cytarabine 1.5 g/m(2) intravenously continuously daily on days 1-4 (days 1-3 if age ≥60 years), and tipifarnib, with the first cohort (n = 6) receiving 200 mg orally twice a day and all others receiving 300 mg twice a day for 21 days every 28 days. Consolidation consisted of 5 courses of idarubicin 8 mg/m(2) a day on days 1-2, cytarabine 0.75 g/m(2) a day on days 1-3, and tipifarnib 300 mg twice a day for 14 days every 4-6 weeks. Maintenance with tipifarnib 300 mg twice a day for 21 days every 4-6 weeks was continued for 6 months.

resultsWith a median follow-up of 33 months, 61 patients achieved complete remission (CR) (64%), and 9 achieved complete remission with incomplete platelet recovery (CRp) (9%). The median duration of CR was not reached. Median overall survival was 17 months. The most common grade 3 adverse events were gastrointestinal toxicities, liver dysfunction, and skin rash. Compared with historical IA, IA and tipifarnib showed a better CR duration (P = .04) and a trend toward a higher CR rate in patients with chromosome 5/7 abnormalities.

conclusionsThe combination of IA and tipifarnib is safe and active. Further studies exploring different dosages and schedules are warranted, particularly in patients with poor-risk AML.

Indexed as

AdolescentAdultAge of OnsetAntineoplastic Combined Chemotherapy ProtocolsCytarabineEnzyme InhibitorsFarnesyltranstransferaseHumansIdarubicinLeukemia, Myeloid, AcuteMiddle AgedMyelodysplastic SyndromesNeoadjuvant TherapyNeoplasm StagingQuinolonesRemission InductionCytarabineEnzyme InhibitorsFarnesyltranstransferaseIdarubicinQuinolonestipifarnib

Identifiers

PMID20960519
PMCPMC4061136
OpenAlexW2045528227

What OpenQuestion holds

Textmetadata
LicenceTDM
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.