Evidence map›Paper›PMID 23261228›Full record

Trial reportLung cancer (Amsterdam, Netherlands)2013

Randomized phase II trial of sulindac for lung cancer chemoprevention.

Paul J Limburg, Sumithra J Mandrekar, Marie Christine Aubry, Katie L Allen Ziegler, Jun Zhang, Joanne E Yi, Michael Henry, Henry D Tazelaar, Stephen Lam, Annette McWilliams and 12 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Lung cancer (Amsterdam, Netherlands), 2013. 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
1.5field-weighted citation impact, top 16% 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, 22 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Why Is Wnt/β-Catenin Not Yet Targeted in Routine Cancer Care?Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  5. Review
  6. The force awakens: metastatic dormant cancer cells.Experimental & molecular medicine · 2020
    Review
  7. Article
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

22 authors at 8 institutions in 1 country.

Paul J LimburgMayo Clinic, 200 First Street SW, Rochester, MN 55905, United States. limburg.paul@mayo.edu
Sumithra J Mandrekar
Marie Christine Aubry
Katie L Allen Ziegler
Jun Zhang
Joanne E Yi
Michael Henry
Henry D Tazelaar
Stephen Lam
Annette McWilliams
David E Midthun
Eric S Edell
Otis B Rickman
Peter Mazzone
Melvyn Tockman
John F Beamis
Carla Lamb
Michael Simoff
Charles Loprinzi
Eva Szabo
James Jett
Cancer Prevention Network
Mayo Clinic in Arizona · USMayo Clinic · USLahey Hospital and Medical Center · USVancouver Clinic · USCleveland Clinic · USHenry Ford Hospital · USNational Institutes of Health · USUniversity of South Florida · US

Funding

ZESTRIL VS. VERAPAMIL IN THE TREATMENT OF HYPERTENSIONM01RR000585 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 1985 to 2006
$30.4M
PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS -261035000N01CN035000 · CN · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LIMBURG, PAUL J · 1985 to 2006
–
NCI NIH HHS N01 CN003500NCI NIH HHS N01 CN035000NCI NIH HHS N01-CN-35000NCRR NIH HHS M01 RR000585NCRR NIH HHS M01-RR00585
6 · The paper itself

Abstract

introductionSulindac represents a promising candidate agent for lung cancer chemoprevention, but clinical trial data have not been previously reported. We conducted a randomized, phase II chemoprevention trial involving current or former cigarette smokers (≥30 pack-years) utilizing the multi-center, inter-disciplinary infrastructure of the Cancer Prevention Network (CPN).

methodsAt least 1 bronchial dysplastic lesion identified by fluorescence bronchoscopy was required for randomization. Intervention assignments were sulindac 150mg bid or an identical placebo bid for 6 months. Trial endpoints included changes in histologic grade of dysplasia (per-participant as primary endpoint and per lesion as secondary endpoint), number of dysplastic lesions (per-participant), and Ki67 labeling index.

resultsSlower than anticipated recruitment led to trial closure after randomizing participants (n=31 and n=30 in the sulindac and placebo arms, respectively). Pre- and post-intervention fluorescence bronchoscopy data were available for 53/61 (87%) randomized, eligible participants. The median (range) of dysplastic lesions at baseline was 2 (1-12) in the sulindac arm and 2 (1-7) in the placebo arm. Change in dysplasia was categorized as regression:stable:progression for 15:3:8 (58%:12%:31%) subjects in the sulindac arm and 15:2:10 (56%:7%:37%) subjects in the placebo arm; these distributions were not statistically different (p=0.85). Median Ki67 expression (% cells stained positive) was significantly reduced in both the placebo (30 versus 5; p=0.0005) and sulindac (30 versus 10; p=0.0003) arms, but the difference between arms was not statistically significant (p=0.92).

conclusionsData from this multi-center, phase II squamous cell lung cancer chemoprevention trial do not demonstrate sufficient benefits from sulindac 150mg bid for 6 months to warrant additional phase III testing. Investigation of pathway-focused agents is necessary for lung cancer chemoprevention.

Indexed as

AdultAgedAnti-Inflammatory Agents, Non-SteroidalAntineoplastic AgentsCarcinoma, Non-Small-Cell LungCell Transformation, NeoplasticChemopreventionFemaleHumansInterdisciplinary StudiesLung NeoplasmsMaleMiddle AgedSmokingSulindacTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalAntineoplastic AgentsSulindac

Identifiers

PMID23261228
PMCPMC3566344
OpenAlexW2118687456

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.