Evidence map›Paper›PMID 25019571›Full record

Trial reportGynecologic oncology2014

A phase II trial of brivanib in recurrent or persistent endometrial cancer: an NRG Oncology/Gynecologic Oncology Group Study.

Matthew A Powell, Michael W Sill, Paul J Goodfellow, Doris M Benbrook, Heather A Lankes, Kimberly K Leslie, Yvette Jeske, Robert S Mannel, Monique A Spillman, Paula S Lee and 3 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03694262 (An Open Label, Non-Randomized Multisite Phase II Trial Combining Bevacizumab, Atezolizumab and Rucaparib for the Treatment of Previously Treated Recurrent and Progressive Endometrial Carcinoma), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
–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.

NCT03694262 phase2completednot on this mapstarted 2019, after this paper: background citation

An Open Label, Non-Randomized Multisite Phase II Trial Combining Bevacizumab, Atezolizumab and Rucaparib for the Treatment of Previously Treated Recurrent and Progressive Endometrial Carcinoma

TypeinterventionalSponsorMedical College of WisconsinRan2019 to 2026Enrolled30ConditionsEndometrial Cancer, Uterine CarcinosarcomaArmsRucaparib, Bevacizumab, Atezolizumab
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. ESGO/ESTRO/ESP Guidelines for the management of patients with endometrial carcinoma.Virchows Archiv : an international journal of pathology · 2021
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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

13 authors.

Matthew A PowellOB/GYN, Washington University School of Medicine, St. Louis, MO 63110, USA. Electronic address: powellm@wudosis.wustl.edu.
Michael W SillGynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. Electronic address: msill@gogstats.org.
Paul J GoodfellowObstetrics and Gynecology, Ohio State University, Columbus, OH, USA. Electronic address: paul.goodfellow@osumc.edu.
Doris M BenbrookUniversity of Oklahoma Health Sciences Center, Oklahoma City, OK 73190, USA. Electronic address: doris-benbrook@ouhsc.edu.
Heather A LankesGynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. Electronic address: hlankes@gogstats.org.
Kimberly K LeslieDepartment of Obstetrics & Gynecology, University of Iowa Hospitals and Clinics, Iowa City, IA 52242, USA. Electronic address: kimberly-leslie@uiowa.edu.
Yvette JeskeInstitute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.
Robert S MannelUniversity of Oklahoma Health Sciences Center, Oklahoma City, OK 73190, USA. Electronic address: Robert-mannel@ouhsc.edu.
Monique A SpillmanOB/GYN, University of Colorado, Denver, CO 80045, USA. Electronic address: monique.spillman@ucdenver.edu.
Paula S LeeDepartment of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC 27710, USA. Electronic address: lee00139@mc.duke.edu.
James S HoffmanThe Hospital of Central Connecticut, New Britain, CT 06050, USA. Electronic address: james.hoffman@hhchealth.org.
D Scott McMeekinUniversity of Oklahoma Health Sciences Center, Oklahoma City, OK 73190, USA. Electronic address: scott-mcmeekin@ouhsc.edu.
Pamela M PollockInstitute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia. Electronic address: Pamela.pollock@qut.edu.au.

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 James J. Dignam · 2014 to 2026
$146.4M
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
Gynecologic Oncology Group Specimen BankingU24CA114793 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 2005 to 2014
$7.0M
Lead Academic Participating Site for the Development and Conduct of NCTN TrialsU10CA180798 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI MANNEL, ROBERT S., MOORE, KATHLEEN N. · 2014 to 2018
$6.7M
Targeted Therapy for Endometrial CancerR01CA099908 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI LESLIE, KIMBERLY K. · 2002 to 2023
$5.8M
Tissue and Pathology CoreP50CA134254 · NCI · WASHINGTON UNIVERSITY · PI POLLOCK, PAMELA M, POWELL, MATTHEW A · 2009 to 2011
$1.7M
NCI NIH HHS 1 U10 CA180822NCI NIH HHS 2R01CA99908NCI NIH HHS CA 27469NCI NIH HHS CA27469NCI NIH HHS CA 37517NCI NIH HHS P50 CA134254NCI NIH HHS R01 CA099908NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180798NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA114793
6 · The paper itself

Abstract

purposeBrivanib, an oral, multi-targeted tyrosine kinase inhibitor with activity against vascular endothelial growth factor (VEGF) and fibroblast growth factor receptor (FGFR) was investigated as a single agent in a phase II trial to assess the activity and tolerability in recurrent or persistent endometrial cancer (EMC). PATIENTS AND

methodsEligible patients had persistent or recurrent EMC after receiving one to two prior cytotoxic regimens, measurable disease, and performance status of ≤2. Treatment consisted of brivanib 800 mg orally every day until disease progression or prohibitive toxicity. Primary endpoints were progression-free survival (PFS) at six months and objective tumor response. Expression of multiple angiogenic proteins and FGFR2 mutation status was assessed.

resultsForty-five patients were enrolled. Forty-three patients were eligible and evaluable. Median age was 64 years. Twenty-four patients (55.8%) received prior radiation. Median number of cycles was two (range 1-24). No GI perforations but one rectal fistula were seen. Nine patients had grade 3 hypertension, with one experiencing grade 4 confusion. Eight patients (18.6%; 90% CI 9.6%-31.7%) had responses (one CR and seven PRs), and 13 patients (30.2%; 90% CI 18.9%-43.9%) were PFS at six months. Median PFS and overall survival (OS) were 3.3 and 10.7 months, respectively. When modeled jointly, VEGF and angiopoietin-2 expression may diametrically predict PFS. Estrogen receptor-α (ER) expression was positively correlated with OS.

conclusionBrivanib is reasonably well tolerated and worthy of further investigation based on PFS at six months in recurrent or persistent EMC.

Indexed as

AdultAgedAged, 80 and overAlanineDisease-Free SurvivalEndometrial NeoplasmsFemaleHumansMiddle AgedNeoplasm Recurrence, LocalReceptor, Fibroblast Growth Factor, Type 2TriazinesVascular Endothelial Growth Factor AAlaninebrivanibFGFR2 protein, humanReceptor, Fibroblast Growth Factor, Type 2TriazinesVascular Endothelial Growth Factor ABrivanibEndometrial cancer

Identifiers

PMID25019571
PMCPMC4278402

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Registered trials

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.