Evidence map›Paper›PMID 18483374›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2008

Phase II trial of tipifarnib as maintenance therapy in first complete remission in adults with acute myelogenous leukemia and poor-risk features.

Judith E Karp, B Douglas Smith, Ivana Gojo, Jeffrey E Lancet, Jacqueline Greer, Maureen Klein, Larry Morris, Mark J Levis, Steven D Gore, John J Wright and 1 more

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

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
3.6field-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

17 citing papers in PubMed, 38 citations in OpenAlex.

  1. Trial
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  5. Article
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  10. Acute myeloid leukemia: focus on novel therapeutic strategies.Clinical Medicine Insights. Oncology · 2012
    Article
  11. Article
  12. Review
  13. Review
  14. New agents for AML and MDS.Best practice & research. Clinical haematology · 2009
    Review
  15. Review
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  17. 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 5 institutions in 1 country.

Judith E KarpJohns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD 21231-1000, USA. jkarp2@jhmi.edu
B Douglas Smith
Ivana Gojo
Jeffrey E Lancet
Jacqueline Greer
Maureen Klein
Larry Morris
Mark J Levis
Steven D Gore
John J Wright
Elizabeth Garrett-Mayer
Sidney Kimmel Comprehensive Cancer Center · USMoffitt Cancer Center · USNational Cancer Institute · USU-M Rogel Cancer CenterUniversity of Maryland, Baltimore · US

Funding

PHASE I TRIALS OF ANTICANCER AGENTSU01CA070095 · NCI · JOHNS HOPKINS UNIVERSITY · PI CARDUCCI, MICHAEL A · 1995 to 2013
$8.6M
PHASE I TRIALS OF ANTICANCER AGENTSU01CA069854 · NCI · UNIVERSITY OF MARYLAND BALTIMORE · PI EDELMAN, MARTIN J · 1995 to 2002
$1.1M
NCI NIH HHS CA 69854NCI NIH HHS U01 CA069854NCI NIH HHS U01 CA070095NCI NIH HHS U01 CA70095
6 · The paper itself

Abstract

purposeAcute myelogenous leukemia (AML) does not have a high cure rate, particularly in patients with poor-risk features. Such patients might benefit from additional therapy in complete remission (CR). Tipifarnib is an oral farnesyltransferase inhibitor with activity in AML. We conducted a phase II trial of maintenance tipifarnib monotherapy for 48 adults with poor-risk AML in first CR. EXPERIMENTAL

designTipifarnib 400 mg twice daily for 14 of 21 days was initiated after recovery from consolidation chemotherapy, for a maximum of 16 cycles (48 weeks).

resultsTwenty (42%) patients completed 16 cycles, 24 (50%) were removed from study for relapse, and 4 (8%) discontinued drug prematurely for intolerance. Nonhematologic toxicities were rare, but tipifarnib dose was reduced in 58% for myelosuppression. Median disease-free survival (DFS) was 13.5 months (range, 3.5-59+ months), with 30% having DFS >2 years. Comparison of CR durations for 25 patients who received two-cycle timed sequential therapy followed by tipifarnib maintenance with 23 historically similar patients who did not receive tipifarnib showed that tipifarnib was associated with DFS prolongation for patients with secondary AML and adverse cytogenetics.

conclusionsThis study suggests that some patients with poor-risk AML, including patients with secondary AML and adverse cytogenetics, may benefit from tipifarnib maintenance therapy. Future studies are warranted to examine alternative tipifarnib dosing and continuation beyond 16 cycles.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaleMiddle AgedQuinolonesRemission InductionRisk FactorsTreatment OutcomeAntineoplastic AgentsQuinolonestipifarnib

Identifiers

PMID18483374
PMCPMC3074480
OpenAlexW2149862494

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.