Evidence map›Paper›PMID 28728751›Full record

Trial reportGynecologic oncology2017

A phase II evaluation of brivanib in the treatment of persistent or recurrent carcinoma of the cervix: An NRG Oncology/Gynecologic Oncology Group study.

John K Chan, Wei Deng, Robert V Higgins, Krishnansu S Tewari, Albert J Bonebrake, Michael Hicks, Stephanie Gaillard, Pedro T Ramirez, Weldon Chafe, Bradley J Monk and 1 more

Abstract readClinical Trial, Phase II
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 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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

9 citing papers in PubMed.

  1. Review
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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

11 authors.

John K ChanDivision of Gynecological Oncology, California Pacific-Palo Alto Medical Foundation, Sutter Cancer Research Institute, San Francisco, CA 94115, United States. Electronic address: chanjohn@sutterhealth.org.
Wei DengNRG Oncology/Gynecologic Oncology Group Statistics & Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States. Electronic address: wdeng@gogstats.org.
Robert V HigginsDivision of Gynecological Oncology, Levine Cancer Institute, Charlotte, NC 28203, United States. Electronic address: robert.higgins@carolinashealthcare.org.
Krishnansu S TewariDivision of Gynecological Oncology, University of California, Irvine Medical Center, Orange, CA 92868, United States. Electronic address: ktewari@uci.edu.
Albert J BonebrakeDivision of Gynecological Oncology, Cancer Research for the Ozarks-Cox Health, Springfield, MO 65807, United States. Electronic address: albert.bonebrake@coxhealth.com.
Michael HicksDivision of Gynecological Oncology, Michigan Cancer Research Consortium, Pontiac, MI 48341, United States. Electronic address: mrhicks2pc@gmail.com.
Stephanie GaillardDivision of Medical Oncology, Duke University Medical Center, Durham, NC 27710, United States. Electronic address: stephanie.gaillard@duke.edu.
Pedro T RamirezDepartment of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States. Electronic address: peramire@mdanderson.org.
Weldon ChafeDivision of Gynecological Oncology, Virginia Commonwealth University, Richmond, VA 23298, United States. Electronic address: wechafe@vcu.edu.
Bradley J MonkDivision of Gynecological Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph's Hospital, Phoenix, AZ 85016, United States. Electronic address: Bradley.Monk@usoncology.com.
Carol AghajanianDepartment of Medical Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, United States. Electronic address: aghajanc@mskcc.org.

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Elaina Harper · 2014 to 2026
$146.4M
Ozark Health Ventures, LLC dba Cancer Research for the Ozarks (CRO)UG1CA189822 · NCI · OZARK HEALTH VENTURES, LLC · PI Jay W Carlson · 2014 to 2026
$14.2M
Johns Hopkins University NCTN Lead Academic Site ProgramU10CA180802 · NCI · JOHNS HOPKINS UNIVERSITY · PI ARMSTRONG, DEBORAH K, BRAHMER, JULIE RENEE · 2014 to 2018
$3.3M
NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189822
6 · The paper itself

Abstract

backgroundBrivanib is an oral, tyrosine kinase inhibitor against vascular endothelial growth factor (VEGF) and fibroblast growth factor receptor (FGFR). We studied its efficacy and tolerability in persistent or recurrent cervical cancer patients.

methodsEligible patients had at least one prior cytotoxic regimen for recurrence and with measurable disease. Brivanib 800mg was administered orally every day (1cycle=28days) until disease progression or prohibitive toxicity. Primary endpoints were progression-free survival (PFS) >6months and objective tumor response.

resultsOf 28 eligible and evaluable women enrolled, 11 (39%) had primary surgery and 25 (89%) had prior radiation. Eighteen (64%) received one prior cytotoxic treatment and 10 (36%) had 2 prior regimens. Twelve (43%) had >2cycles of brivanib with 4 (14%) receiving >10cycles (range: 1-20). Seven (25%) patients had PFS >6months (90% CI: 7.3%-33.9%). Two (7%) (90% CI: 1.3%-20.8%) patients had partial tumor response with duration of 8 and 22months and 12 (43%) had stable disease. The median PFS was 3.2months (90% CI: 2.1-4.4). The median overall survival was 7.9months (90% CI: 6.1-11.7). More common grade 3 adverse events were hypertension, anemia, hyponatremia, hyperglycemia, elevated liver enzymes, nausea, headache, and colon hemorrhage. Grade 4 adverse events included sepsis and hypertension.

conclusionsBased on early results of this phase II trial, brivanib was well tolerated and demonstrated sufficient activity after first stage but trial was stopped due to lack of drug availability.

Indexed as

AdultAgedAged, 80 and overAlanineAntineoplastic AgentsCarcinomaDisease-Free SurvivalDisease ProgressionEarly Termination of Clinical TrialsFemaleHumansMiddle AgedNeoplasm Recurrence, LocalResponse Evaluation Criteria in Solid TumorsRetreatmentSurvival RateAlanineAntineoplastic AgentsbrivanibTriazinesBrivanibRecurrent cervical carcinoma

Identifiers

PMID28728751
PMCPMC5728988

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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.