Evidence map›Paper›PMID 28285845›Full record

Trial reportGynecologic oncology2017

A stratified randomized double-blind phase II trial of celecoxib for treating patients with cervical intraepithelial neoplasia: The potential predictive value of VEGF serum levels: An NRG Oncology/Gynecologic Oncology Group study.

Janet S Rader, Michael W Sill, Jan H Beumer, Heather A Lankes, Doris Mangiaracina Benbrook, Francisco Garcia, Connie Trimble, J Tate Thigpen, Richard Lieberman, Rosemary E Zuna and 6 more

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

Trial report in Gynecologic oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 14% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
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  5. Article
  6. Drug repurposing for cancer therapy.Signal transduction and targeted therapy · 2024
    Review
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  12. Curbing Lipids: Impacts ON Cancer and Viral Infection.International journal of molecular sciences · 2019
    Review
  13. The role of EP3-receptor expression in cervical dysplasia.Journal of cancer research and clinical oncology · 2019
    Article
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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 13 institutions in 1 country.

Janet S RaderDepartment of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, WI 53226, United States. Electronic address: jrader@mcw.edu.
Michael W SillNRG Oncology/Gynecologic Oncology Group Statistics & Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States. Electronic address: msill@gogstats.org.
Jan H BeumerCancer Therapeutics Program, University of Pittsburgh Cancer Institute, Department of Pharmaceutical Sciences, School of Pharmacy, Division of Hematology-Oncology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, United States; Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, United States. Electronic address: beumerjh@upmc.edu.
Heather A LankesNRG Oncology/Gynecologic Oncology Group Statistics & Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States. Electronic address: hlankes@gogstats.org.
Doris Mangiaracina BenbrookStephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, 73165. Electronic address: Doris-Benbrook@ouhsc.edu.
Francisco GarciaDepartment of Obstetrics & Gynecology, University of Arizona, Mel & Enid Zuckerman College of Public Health, Tucson, AZ 85724, United States. Electronic address: Francisco.Garcia@pima.gov.
Connie TrimbleDivision of Gynecologic Specialties, Johns Hopkins Medical Institutions, Baltimore, MD 21287, United States. Electronic address: ctrimbl@jhmi.edu.
J Tate ThigpenDepartment of Gynecologic Oncology, University of Mississippi Medical Center, Jackson, MS 39216, United States.
Richard LiebermanDivision of OB/GYN and Pathology, University of Michigan Health System, Ann Arbor, MI 48109, United States. Electronic address: jakrwl@med.umich.edu.
Rosemary E ZunaDepartment of Pathology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, United States. Electronic address: Rosemary-Zuna@ouhsc.edu.
Charles A LeathDivision of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham, AL 35233, United States. Electronic address: cleath@uabmc.edu.
Nick M SpirtosDivision of Gynecologic Oncology, Women's Cancer Center of Nevada, Las Vegas, NV 89169, United States. Electronic address: nspirtos@wccenter.com.
John ByronDepartment of OB/GYN, First Health of the Carolinas - Moore Regional Hospital, Southern Pines, NC 28388, United States. Electronic address: JByron@spwhc.com.
Premal H ThakerDivision of Gynecologic Oncology, Washington University School of Medicine, Saint Louis, MO 63110, United States. Electronic address: thakerp@wudosis.wustl.edu.
Shashikant LeleDepartment of Gynecologic Oncology, Roswell Park Cancer Institute, Buffalo, NY 14263, United States. Electronic address: shashi.lele@roswellpark.org.
David AlbertsDepartment of Medical Oncology, The University of Arizona Cancer Center-North Campus, Tucson, AZ 85724, United States. Electronic address: DAlberts@uacc.arizona.edu.
NRG Oncology · USUniversity of Arizona · USUniversity of Oklahoma Health Sciences Center · USFirstHealth of the Carolinas · USJohns Hopkins University · USMedical College of Wisconsin · USMichigan Medicine · USRoswell Park Comprehensive Cancer Center · USUniversity of Alabama at Birmingham · USUniversity of Mississippi Medical Center · USUPMC Hillman Cancer Center · USWashington University in St. Louis · USWomen's Cancer Center of Nevada · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD · 1988 to 2026
$158.0M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
GYNECOLOGIC ONCOLOGY GROUP HEADQUARTERSU10CA027469 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 1985 to 2013
$132.6M
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI BLESSING, JOHN A · 1985 to 2013
$67.4M
NRG Oncology Biospecimen BankU24CA196067 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Tanner J. Freeman, Nilsa Del Carmen Ramirez Milan · 2015 to 2026
$42.6M
Washington University/ Siteman Cancer Center Lead Academic SiteU10CA180833 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L, KOZOWER, BENJAMIN D · 2014 to 2018
$7.6M
Gynecologic Oncology Group Specimen BankingU24CA114793 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 2005 to 2014
$7.0M
NCI NIH HHS P30 CA047904NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA114793NCI NIH HHS U24 CA196067NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

purposeTo examine the effect of celecoxib on cervical intraepithelial neoplasia 3 (CIN 3). This is a NRG Oncology/Gynecologic Oncology Group study with translational biomarkers. PATIENTS AND

methodsPatients with CIN 3 were randomized to celecoxib 400mg once daily (67 patients) or placebo (63 patients) for 14-18weeks. The primary outcome measure was histologic regression. A test of equal probabilities of success between two therapies was conducted, using Fisher's Exact Test at alpha=10% and 90% power when the treatment arm boosted the probability of success by 30%. Translational analysis included cervical tissue HPV genotyping, COX-2 expression in biopsies, and serum celecoxib and VEGF levels.

resultsIn primary analysis, histologic regression was not significantly higher in the celecoxib group (40%) than in the placebo group (34.1%). However, exploratory analyses suggest patients with high serum VEGF levels exhibited greater regression in the celecoxib arm (47.3%) than in the placebo arm (14.3%). Regression rates were similar by treatment group in patients with low VEGF. VEGF levels increased over time in the placebo group, but remained the same in the treatment group. COX-2 expression in cervical biopsies declined from pre-treatment to the end of treatment with celecoxib; it did not change with placebo.

conclusionsCelecoxib at 400mg once daily for 14-18weeks did not significantly decrease the severity of CIN 3 compared with placebo except, possibly, in subjects with high baseline VEGF. Therefore, serum VEGF levels might identify patients who may benefit from celecoxib or other therapies, personalizing future chemoprevention trials for CIN 3.

Indexed as

AdolescentAdultBiomarkers, TumorCelecoxibCyclooxygenase 2Cyclooxygenase 2 InhibitorsDouble-Blind MethodFemaleHumansMiddle AgedPapillomaviridaePapillomavirus InfectionsUterine Cervical DysplasiaUterine Cervical NeoplasmsVascular Endothelial Growth Factor AYoung AdultBiomarkers, TumorCelecoxibCyclooxygenase 2Cyclooxygenase 2 InhibitorsPTGS2 protein, humanVascular Endothelial Growth Factor AVEGFA protein, humanCelecoxibCervixChemopreventionCIN 3COX-2VEGF

Identifiers

PMID28285845
PMCPMC5794341
OpenAlexW2592471038

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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.