Evidence map›Paper›PMID 26186911›Full record

Trial reportGynecologic oncology2015

A phase II evaluation of cediranib in the treatment of recurrent or persistent endometrial cancer: An NRG Oncology/Gynecologic Oncology Group study.

David Bender, Michael W Sill, Heather A Lankes, Henry D Reyes, Christopher J Darus, James E Delmore, Jacob Rotmensch, Heidi J Gray, Robert S Mannel, Jeanne M Schilder and 4 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Gynecologic oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04197219 (Pembrolizumab With Axitinib in Recurrent Endometrial Cancer With Deficient Mismatch Repair System Post PD1 Exposure), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing 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.

NCT04197219 phase2withdrawnnot on this mapstarted 2021, after this paper: background citation

Pembrolizumab With Axitinib in Recurrent Endometrial Cancer With Deficient Mismatch Repair System Post PD1 Exposure: Phase II Trial

TypeinterventionalSponsorCase Comprehensive Cancer CenterRan2021 to 2026Enrolled0ConditionsRecurrent Endometrial CancerArmsPembrolizumab, Axitinib
3 · Its place in the literature

Who cites it

30 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

14 authors.

David BenderGynecologic Oncology Division, University of Iowa, Gyn/Onc Division, Iowa City, IA 52242, United States. Electronic address: david-bender@uiowa.edu.
Michael W SillNRG Oncology Statistics & Data Management Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States. Electronic address: msill@gogstats.org.
Heather A LankesNRG Oncology Statistics & Data Management Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States. Electronic address: hlankes@gogstats.org.
Henry D ReyesGynecologic Oncology Division, University of Iowa, Gyn/Onc Division, Iowa City, IA 52242, United States. Electronic address: henry-reyes@uiowa.edu.
Christopher J DarusDivision of Gynecologic Oncology, Maine Medical Center, Scarborough, ME 04101, United States. Electronic address: cdarus@gmail.com.
James E DelmoreUniversity of Kansas School of Medicine, Wichita CCOP, Wichita, KS 67208, United States. Electronic address: james.delmore@awhobgyn.com.
Jacob RotmenschDivision of Gynecologic Oncology, Rush-Presbyterian St. Lukes Medical Center, Chicago, IL 60612, United States. Electronic address: jacob_rotmensch@rush.edu.
Heidi J GrayDept. of OB/GYN, University of Washington, Seattle, WA 98195, United States. Electronic address: hgray@u.washington.edu.
Robert S MannelDept. of OB/GYN, The University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, United States. Electronic address: robert-mannel@ouhsc.edu.
Jeanne M SchilderDept. of Gyn/Onc, Indiana University Medical Center, Indianapolis, IN 46202, United States. Electronic address: jschilde@iupui.edu.
Mark I HunterEllis Fischel Cancer Center, Columbia, MO 65203, United States. Electronic address: hunterm@health.missouri.edu.
Carolyn K McCourtDept. of Oncology, Women & Infants Hospital, Providence, RI 02905, United States. Electronic address: McCourtc@wudosis.wustl.edu.
Megan I SamuelsonGynecologic Oncology Division, University of Iowa, Gyn/Onc Division, Iowa City, IA 52242, United States.
Kimberly K LeslieGynecologic Oncology Division, University of Iowa, Gyn/Onc Division, Iowa City, IA 52242, United States. Electronic address: Kimberly-leslie@uiowa.edu.

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
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
Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Douglas Robert Spitz · 2000 to 2026
$70.0M
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
Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval ProcessUL1TR002529 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI MOE, SHARON M, WIEHE, SARAH ELIZABETH · 2018 to 2022
$27.2M
Indiana Clinical and Translational Sciences InstituteUL1TR001108 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI DENNE, SCOTT C., SHEKHAR, ANANTHA · 2013 to 2017
$23.3M
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
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
NCATS NIH HHS UL1 TR001108NCI NIH HHS 1 U10 CA180822NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS R01 CA099908NCI NIH HHS R01-CA099908NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180798NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180868NCI NIH HHS U10CA180868NCI NIH HHS U24 CA114793NCI NIH HHS U24 CA196067NCI NIH HHS UG1 CA189867NICHD NIH HHS K12 HD063117
6 · The paper itself

Abstract

purposeCediranib is a multi-tyrosine kinase inhibitor targeting vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF) receptors. This phase II study was conducted to assess activity and tolerability of single-agent cediranib in recurrent/persistent endometrial cancer. PATIENTS AND

methodsEligible patients had recurrent or persistent endometrial cancer after receiving one or two prior cytotoxic regimens, measurable disease, and Gynecologic Oncology Group (GOG) performance status of ≤2 (≤1 if two prior cytotoxic regimens given). Cediranib 30mg orally daily for a 28daycycle was administered until disease progression or prohibitive toxicity. Microvessel density (MVD) was measured in tumor tissue from initial hysterectomy specimens and correlated with clinical outcome. Primary endpoints were tumor response and surviving progression-free for six months without subsequent therapy (6-month event-free survival [EFS]).

resultsOf 53 patients enrolled, 48 were evaluable for cediranib efficacy and toxicity. Median age was 65.5 years, 52% of patients had received prior radiation, and 73% of patients received only one prior chemotherapy regimen. A partial response was observed in 12.5%. Fourteen patients (29%) had six-month EFS. Median progression-free survival (PFS) was 3.65 months and median overall survival (OS) 12.5 months. No grade 4 or 5 toxicities were observed. A trend towards improved PFS was found in patients whose tumors expressed high MVD.

conclusionCediranib as a monotherapy treatment for recurrent or persistent endometrial cancer is well tolerated and met protocol set objectives for sufficient activity to warrant further investigation. MVD may be a useful biomarker for activity.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsEndometrial NeoplasmsFemaleHumansIndolesMiddle AgedNeoplasm Recurrence, LocalProtein Kinase InhibitorsQuinazolinesAntineoplastic AgentscediranibIndolesProtein Kinase InhibitorsQuinazolinesAngiogenesisFibroblast growth factor receptorPlatelet derived growth factor receptorTargeted therapyTyrosine kinase inhibitorVascular endothelial growth factor receptor

Identifiers

PMID26186911
PMCPMC4642817

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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.