Evidence map›Paper›PMID 27002448›Full record

Trial reportJAMA

Effect of Sulindac and Erlotinib vs Placebo on Duodenal Neoplasia in Familial Adenomatous Polyposis: A Randomized Clinical Trial.

N Jewel Samadder, Deborah W Neklason, Kenneth M Boucher, Kathryn R Byrne, Priyanka Kanth, Wade Samowitz, David Jones, Sean V Tavtigian, Michelle W Done, Therese Berry and 11 more

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 76 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 2 pooled it
16.9field-weighted citation impact, top 1% 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

76 citing papers in PubMed, 2 syntheses or guidelines pooled it, 140 citations in OpenAlex.

  1. Guideline
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  3. Trial
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  7. Trial
  8. Review
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  10. Adenomatous Polyposis Coli Gene Polyposis-Related Syndromes.The American journal of gastroenterology · 2026
    Review
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  13. Review
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  15. Article
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16 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 6 institutions in 1 country.

N Jewel SamadderHuntsman Cancer Institute, University of Utah, Salt Lake City2Department of Medicine (Gastroenterology), University of Utah, Salt Lake City.
Deborah W NeklasonHuntsman Cancer Institute, University of Utah, Salt Lake City3Department of Oncological Sciences, University of Utah, Salt Lake City4Department of Medicine (Genetic Epidemiology), University of Utah, Salt Lake City.
Kenneth M BoucherHuntsman Cancer Institute, University of Utah, Salt Lake City5Department of Medicine (Epidemiology), University of Utah, Salt Lake City.
Kathryn R ByrneDepartment of Medicine (Gastroenterology), University of Utah, Salt Lake City.
Priyanka KanthDepartment of Medicine (Gastroenterology), University of Utah, Salt Lake City.
Wade SamowitzHuntsman Cancer Institute, University of Utah, Salt Lake City6Department of Pathology, University of Utah, Salt Lake City.
David JonesHuntsman Cancer Institute, University of Utah, Salt Lake City3Department of Oncological Sciences, University of Utah, Salt Lake City.
Sean V TavtigianHuntsman Cancer Institute, University of Utah, Salt Lake City3Department of Oncological Sciences, University of Utah, Salt Lake City.
Michelle W DoneHuntsman Cancer Institute, University of Utah, Salt Lake City.
Therese BerryHuntsman Cancer Institute, University of Utah, Salt Lake City.
Kory JaspersonHuntsman Cancer Institute, University of Utah, Salt Lake City.
Lisa PappasHuntsman Cancer Institute, University of Utah, Salt Lake City.
Laurel SmithHuntsman Cancer Institute, University of Utah, Salt Lake City.
Danielle SampleHuntsman Cancer Institute, University of Utah, Salt Lake City.
Rian DavisHuntsman Cancer Institute, University of Utah, Salt Lake City.
Matthew K TophamHuntsman Cancer Institute, University of Utah, Salt Lake City3Department of Oncological Sciences, University of Utah, Salt Lake City7Department of Medicine (Pulmonary), University of Utah, Salt Lake City.
Patrick LynchDepartment of Gastroenterology, University of Texas MD Anderson Cancer Center, Houston.
Elena StraitPenrose Hospital, Colorado Springs, Colorado.
Wendy McKinnonUniversity of Vermont Cancer Center, Burlington.
Randall W BurtHuntsman Cancer Institute, University of Utah, Salt Lake City2Department of Medicine (Gastroenterology), University of Utah, Salt Lake City3Department of Oncological Sciences, University of Utah, Salt Lake City.
Scott K KuwadaDepartment of Medicine, University of Hawaii, Honolulu.
University of Utah · USHuntsman Cancer Institute · USPenrose Hospital · USThe University of Texas MD Anderson Cancer Center · USUniversity of Hawaii System · USUniversity of Vermont · US

Funding

UTAH REGIONAL CANCER CENTERP30CA042014 · NCI · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI Jared P Rutter · 1986 to 2026
$72.6M
TCF/LEF function during intestinal maintenance and colon tumorigenesisP01CA073992 · NCI · UNIVERSITY OF UTAH · PI NEKLASON, DEBORAH WOOD · 1998 to 2014
$29.7M
University of Utah Center for Clinical and Translational ScienceUL1TR001067 · NCATS · UNIVERSITY OF UTAH · PI DERE, WILLARD H., HESS, RACHEL · 2013 to 2017
$19.8M
NCATS NIH HHS UL1 TR001067NCI NIH HHS P01 CA073992NCI NIH HHS P01-CA073992NCI NIH HHS P30 CA042014NCI NIH HHS P30CA042014PHS HHS 1ULTR001067
6 · The paper itself

Abstract

importancePatients with familial adenomatous polyposis (FAP) are at markedly increased risk for duodenal polyps and cancer. Surgical and endoscopic management of duodenal neoplasia is difficult and chemoprevention has not been successful.

objectiveTo evaluate the effect of a combination of sulindac and erlotinib on duodenal adenoma regression in patients with FAP. DESIGN, SETTING, AND

participantsDouble-blind, randomized, placebo-controlled trial, enrolling 92 participants with FAP, conducted from July 2010 through June 2014 at Huntsman Cancer Institute in Salt Lake City, Utah.

interventionsParticipants with FAP were randomized to sulindac (150 mg) twice daily and erlotinib (75 mg) daily (n = 46) vs placebo (n = 46) for 6 months. MAIN OUTCOMES AND MEASURES: The total number and diameter of polyps in the proximal duodenum were mapped at baseline and 6 months. The primary outcome was change in total polyp burden at 6 months. Polyp burden was calculated as the sum of the diameters of polyps. The secondary outcomes were change in total duodenal polyp count, change in duodenal polyp burden or count stratified by genotype and initial polyp burden, and percentage of change from baseline in duodenal polyp burden.

resultsNinety-two participants (mean age, 41 years [range, 24-55]; women, 56 [61%]) were randomized when the trial was stopped by the external data and safety monitoring board because the second preplanned interim analysis met the prespecified stopping rule for superiority. Grade 1 and 2 adverse events were more common in the sulindac-erlotinib group, with an acne-like rash observed in 87% of participants receiving treatment and 20% of participants receiving placebo (P < .001). Only 2 participants experienced grade 3 adverse events. [table: see text]. CONCLUSIONS AND RELEVANCE: Among participants with FAP, the use of sulindac and erlotinib compared with placebo resulted in a lower duodenal polyp burden after 6 months. Adverse events may limit the use of these medications at the doses used in this study. Further research is necessary to evaluate these preliminary findings in a larger study population with longer follow-up to determine whether the observed effects will result in improved clinical outcomes.

trial registrationclinicaltrials.gov Identifier: NCT 01187901.

Indexed as

Adenomatous Polyposis ColiAdultAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDuodenal NeoplasmsErlotinib HydrochlorideFemaleGenes, APCHumansMaleMiddle AgedSulindacAntineoplastic AgentsErlotinib HydrochlorideSulindac

Identifiers

PMID27002448
PMCPMC5003411
OpenAlexW2304625472

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.