Evidence map›Paper›PMID 22907422›Full record

Trial reportCancer causes & control : CCC2012

Role of obesity in a randomized placebo-controlled trial of difluoromethylornithine (DFMO) + sulindac for the prevention of sporadic colorectal adenomas.

Jason A Zell, Bruce S Lin, Nikki Madson, Christine E McLaren, Eugene W Gerner, Frank L Meyskens

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer causes & control : CCC, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 44% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Chemoprevention Against Gastric Cancer.Gastrointestinal endoscopy clinics of North America · 2021
    Review
  4. 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

6 authors at 2 institutions in 1 country.

Jason A ZellChao Family Comprehensive Cancer Center, University of California, Irvine, CA 92697, USA. jzell@uci.edu
Bruce S Lin
Nikki Madson
Christine E McLaren
Eugene W Gerner
Frank L Meyskens
University of California, Irvine · USUniversity of Arizona · US

Funding

VITAMIN AP30CA023074 · NCI · UNIVERSITY OF ARIZONA · PI Teri L Bankhead · 1985 to 2026
$110.2M
Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Melanie Funes · 1994 to 2026
$57.9M
SPORE in Gastrointestinal CancerP50CA095060 · NCI · UNIVERSITY OF ARIZONA · PI GERNER, EUGENE W · 2002 to 2012
$25.3M
Phase III Colon Cancer Prevention TrialR01CA088078 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI MEYSKENS, FRANK L. · 2002 to 2006
$4.2M
PHASE II CLINICAL TRIAL OF DFMO &NSAID IN COLONN01CN075019 · CN · UNIVERSITY OF CALIFORNIA-IRVINE · PI MEYSKENS, FRANK L. · 1997 to 2006
–
POLYAMINE DEPLETION AND CHEMOPREVENTION OF COLON CANCERR01CA059024 · NCI · UNIVERSITY OF CALIFORNIA IRVINE · PI MEYSKENS, FRANK LOUIS · 1993 to 1996
–
NCI NIH HHS CA23074NCI NIH HHS CA88078NCI NIH HHS CA95060NCI NIH HHS N01 CN075019NCI NIH HHS N01-CN75019NCI NIH HHS P30 CA023074NCI NIH HHS P30 CA062203NCI NIH HHS P30 CA62230NCI NIH HHS P50 CA095060NCI NIH HHS R01 CA059024NCI NIH HHS R01 CA088078
6 · The paper itself

Abstract

backgroundChemoprevention with the polyamine-inhibitory regimen difluoromethylornithine (DFMO) + sulindac markedly reduces risk of recurrent adenoma in colorectal adenoma patients. Obesity is associated with risk of colorectal adenoma and colorectal cancer. This study investigates how obesity influences risk of recurrent adenoma after prolonged treatment with DFMO + sulindac versus placebo.

methodsOur analysis included subjects enrolled in the phase III colorectal adenoma prevention clinical trial investigating DFMO + sulindac versus placebo. Patients were classified by obesity (body mass index, BMI ≥ 30 kg/m(2)) status at baseline. Pearson χ(2) statistic and Mann-Whitney U test were used to compare baseline characteristics, including rectal tissue polyamine levels. Log-binomial regression analysis was used to determine the risk ratio (RR) of recurrent adenomas, adjusted for covariates and an interaction term for obesity and treatment.

resultsThe final analytic cohort was comprised of 267 patients. In separate regression models, the risk of adenoma recurrence after treatment compared to placebo was similar for obese (RR = 0.32, 95 % CI 15-71) and non-obese patients (RR = 0.27, 95 % CI 15-49). No significant interaction was detected between obesity, treatment, and risk of colorectal adenoma in the full regression model (p (interaction) = 0.91).

conclusionsObesity does not substantially modify the colorectal adenoma risk reduction ascribed to DFMO + sulindac versus placebo.

Indexed as

AdenomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDouble-Blind MethodEflornithineFemaleHumansMaleMiddle AgedObesityPlacebo EffectPolyaminesRegression AnalysisEflornithinePolyaminesSulindac

Identifiers

PMID22907422
PMCPMC3443348
OpenAlexW2113834939

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.