Evidence map›Paper›PMID 34773794›Full record

Trial reportLeukemia research2021

Tipifarnib as maintenance therapy did not improve disease-free survival in patients with acute myelogenous leukemia at high risk of relapse: Results of the phase III randomized E2902 trial.

Selina M Luger, Victoria X Wang, Jacob M Rowe, Mark R Litzow, Elisabeth Paietta, Rhett P Ketterling, Hillard Lazarus, Witold B Rybka, Michael D Craig, Judith Karp and 6 more

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Leukemia research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.4field-weighted citation impact, top 36% 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

7 citing papers in PubMed, 6 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

16 authors at 14 institutions in 2 countries.

Selina M LugerAbramson Cancer Center, University of Pennsylvania, Perelman Center for Advanced Medicine, South Tower, 12th Floor, Philadelphia, PA, PA 19104, United States. Electronic address: Selina.luger@pennmedicine.upenn.edu.
Victoria X WangDana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, AMA, United States.
Jacob M RoweRambam Medical Center, Haifa, Israel.
Mark R LitzowMayo Clinic, Rochester, MN, United States.
Elisabeth PaiettaMontefiore Medical Center, Bronx, NY, United States.
Rhett P KetterlingMayo Clinic, Rochester, MN, United States.
Hillard LazarusCase Western Reserve University, Cleveland, OH, United States.
Witold B RybkaPenn State Hershey Cancer Institute, Hershey, PA, United States.
Michael D CraigWest Virginia University Healthcare, Morgantown, WB, United States.
Judith KarpJohns Hopkins University, Baltimore, MD, United States.
Brenda W CooperCase Western Reserve University, Cleveland, OH, United States.
Adel Z MakaryGeisinger Medical Center, Danville, PA, United States.
Lynne S KaminerNorth Shore Health System-Evanston Hospital, Evanston, IL, United States.
Frederick R AppelbaumFred Hutchinson Cancer Research Center, Seattle, WA, United States.
Richard A LarsonUniversity of Chicago, Chicago, IL, United States.
Martin S TallmanNorthwestern University, Chicago, IL, United States(1); Memorial Sloan Kettering Cancer Center, NY, NY, United States(2).
Case Western Reserve University · USMayo Clinic in Arizona · USECOG-ACRIN Cancer Research Group · USFred Hutch Cancer Center · USGeisinger Medical Center · USJohns Hopkins University · USMemorial Sloan Kettering Cancer Center · USMontefiore Medical Center · USNorthShore University HealthSystem · USPenn State Milton S. Hershey Medical Center · USRambam Health Care Campus · ILUniversity of Chicago · USUniversity of Pennsylvania · USWest Virginia University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI DAWN HERSHMAN, PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO · 2014 to 2026
$111.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
Geisinger Cancer Institute Oncology Research ProgramUG1CA189847 · NCI · GEISINGER CLINIC · PI Rajiv Panikkar · 2014 to 2026
$16.0M
Case Comprehensive Cancer Center NCTN Lead Academic Participating SiteUG1CA233234 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI Aaron Thomas Gerds, Daniel Eidelberg Spratt · 2019 to 2026
$11.1M
Montefiore Academic Community NCORP ProgramUG1CA189859 · NCI · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI Balazs Halmos, Della Makower · 2014 to 2026
$10.8M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer CenterUG1CA233184 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ADAM M BRUFSKY, John Munn Kirkwood · 2019 to 2026
$7.7M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180791NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180828NCI NIH HHS U10 CA180836NCI NIH HHS U10 CA180844NCI NIH HHS U10 CA180853NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189847NCI NIH HHS UG1 CA189859NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233184NCI NIH HHS UG1 CA233196NCI NIH HHS UG1 CA233234NCI NIH HHS UG1 CA233327NCI NIH HHS UG1 CA233328
6 · The paper itself

Abstract

purposeDespite the achievement of complete remission with chemotherapy in patients with acute myeloid leukemia (AML), relapse is common and the majority of patients will die of their disease. Patients who achieve a remission after refractory or relapsed disease as well as elderly patients have a very high rate of relapse even if they achieve a complete remission. A phase 3 randomized ECOG-ACRIN-led intergroup study was conducted to determine whether post-remission therapy with the farnesyl transferase inhibitor, tipifarnib (R115777), improved the disease-free survival (DFS) of adult patients with AML in complete remission (CR), at high risk for relapse. PATIENTS AND

methodsAdult patients with AML in remission after salvage therapy and/or over age 60 in first remission were enrolled in this study. They were randomly assigned to treatment with tipifarnib or observation (control). The primary objective was to compare the disease-free survival (DFS) between the two arms based on intention to treat, which includes all randomized patients.

resultsOne hundred and forty-four patients were enrolled on the study. Median DFS was 8.9 vs 5.3 months, for tipifarnib vs observation (one-sided p = 0.026) and did not cross the pre-specified boundary to call the study positive. For the 134 eligible patients, median DFS was 10.8 vs 5.3 months for those randomized to tipifarnib vs observation (one-sided p = 0.008). Moreover in an ad hoc evaluation of all women (n = 71) median DFS was 12.1 vs 3.9 months for tipifarnib vs observation (one-sided p = 0.0004) while median OS was 26.5 vs 8.4 months respectively (one-sided p = 0.001).

conclusionThis study was not able to demonstrate a benefit to tipifarnib as maintenance therapy in patients with AML in remission. While subsets of patients may indeed benefit, additional studies would be needed to elucidate that benefit which is unlikely given that other seemingly better options have since become available.

Indexed as

Antineoplastic AgentsFemaleFollow-Up StudiesHumansLeukemia, Myeloid, AcuteMaintenance ChemotherapyMaleMiddle AgedNeoplasm Recurrence, LocalPrognosisProspective StudiesQuinolonesSalvage TherapySurvival RateAntineoplastic AgentsQuinolonestipifarnibAMLMaintenanceTipifarnib

Identifiers

PMID34773794
PMCPMC8643322
OpenAlexW3210377225

What OpenQuestion holds

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Registered trials

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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.