Evidence map›Paper›PMID 34955443›Full record

ArticleJournal of geriatric oncology2022

Phase Ib trial of lenalidomide as post-remission therapy for older adults with acute myeloid leukemia: Safety and longitudinal assessment of geriatric functional domains.

Justin D Woods, Joshua F Zeidner, Hendrik W Van Deventer, Katarzyna Jamieson, Melissa Matson, Jack Zhang, William Pulley, Tucker Brenizer, Hyman Muss, Kirsten A Nyrop and 4 more

Open access · greenAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of geriatric oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 48% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

14 authors at 2 institutions in 1 country.

Justin D WoodsDepartment of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Joshua F ZeidnerDepartment of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Hendrik W Van DeventerDepartment of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Katarzyna JamiesonDepartment of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Melissa MatsonLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Pediatrics, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Jack ZhangLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
William PulleyLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Tucker BrenizerLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Hyman MussDepartment of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Kirsten A NyropDepartment of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Sanah N VohraLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
Allison M DealLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Anastasia IvanovaLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
Matthew C FosterDepartment of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA. Electronic address: matthew_foster@med.unc.edu.
UNC Lineberger Comprehensive Cancer CenterUniversity of North Carolina at Chapel Hill · US

Funding

Cancer Control Education ProgramT32CA057726 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Melissa B Gilkey, Melissa A. Troester · 2017 to 2026
$3.7M
NCI NIH HHS T32 CA057726
6 · The paper itself

Abstract

BACKGROUND AND

objectivesNovel, non-cytotoxic agents are driving a paradigm shift for treatment of older adults with acute myeloid leukemia (AML). Older patients who initially receive intensive cytotoxic induction may choose to not proceed with cytotoxic consolidation therapy. Lenalidomide is an orally-administered immunomodulatory small molecule with activity in AML and a favorable safety profile in older adults with active leukemia. We conducted a phase Ib study of lenalidomide as post-remission therapy in older adults and assessed its impact on geriatric functional domains. MATERIALS AND

methodsParticipants were patients with AML over age 60 years who had undergone induction therapy and were poor candidates for cytotoxic consolidation. Lenalidomide was administered for 28 days in three dose cohorts. A Bayesian dose-escalation method determined cohort assignment and maximum tolerated dose (MTD). Geriatric assessment (GA) was performed before and after the cycle of lenalidomide.

resultsNineteen patients with median age 68 were treated with at least one 28-day course of lenalidomide. Dose-limiting toxicities were observed in three participants at 25 mg, zero participants at 35 mg, and one participant at 50 mg. MTD was 35 mg. Median relapse-free survival was 4.3 months. GA was completed before and after treatment in fifteen patients, demonstrating improved cognitive function and no changes in physical, psychological, or social function after lenalidomide.

conclusionLenalidomide can be safely administered to older adults with AML with preservation of functional domains important to older patients. Serial GA can be performed in a novel drug study as a tool to characterize treatment tolerability.

Indexed as

LenalidomideLeukemia, Myeloid, AcuteAgedAntineoplastic AgentsBayes TheoremCohort StudiesHumansAntineoplastic AgentsLenalidomideAcute myeloid leukemiaGeriatric assessmentLenalidomide

Identifiers

PMID34955443
PMCPMC9326773
OpenAlexW4200358255

What OpenQuestion holds

Textmetadata
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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.