Evidence map›Paper›PMID 25887099›Full record

Trial reportGynecologic oncology2015

A phase II evaluation of selumetinib (AZD6244, ARRY-142886), a selective MEK-1/2 inhibitor in the treatment of recurrent or persistent endometrial cancer: an NRG Oncology/Gynecologic Oncology Group study.

Robert L Coleman, Michael W Sill, Premal H Thaker, David P Bender, Daron Street, William P McGuire, Carolyn M Johnston, Jacob Rotmensch

Abstract readClinical Trial, Phase IIMulticenter Study
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. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 pooled it
8.5field-weighted citation impact, top 2% 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

39 citing papers in PubMed, 1 synthesis or guideline pooled it, 77 citations in OpenAlex.

  1. ESGO/ESTRO/ESP Guidelines for the management of patients with endometrial carcinoma.Virchows Archiv : an international journal of pathology · 2021
    Guideline
  2. Phase I/II Study of Combined BCL-xL and MEK Inhibition with Navitoclax and Trametinib in KRAS or NRAS Mutant Advanced Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Trial
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  6. Review
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  10. Clinical and Genomic Landscape of RAS Mutations in Gynecologic Cancers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    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

8 authors at 8 institutions in 1 country.

Robert L ColemanDept. of Gynecologic Oncology & Reproductive Medicine, University of Texas, M.D. Anderson Cancer Center, Houston, TX 77030. Electronic address: rcoleman@mdanderson.org.
Michael W SillNRG Oncology Statistics & Data Management Center; Roswell Park Cancer Institute, Buffalo, NY 14263. Electronic address: msill@gogstats.org.
Premal H ThakerDivision of Gynecologic Oncology, Washington University School of Medicine, St. Louis, MO 63110. Electronic address: thakerp@wudosis.wustl.edu.
David P BenderUniversity of Iowa; Gyn/Onc Division; Iowa City, IA 52242. Electronic address: david-bender@uiowa.edu.
Daron StreetCancer Care Associates; Tulsa, OK 74136. Electronic address: daron.street@tciok.org.
William P McGuireFranklin Square Hospital; Medical Oncology; Baltimore, MD 21237. Electronic address: wmcguire52@aol.com.
Carolyn M JohnstonDivision. of Gynecologic Oncology; University of Michigan; Ann Arbor, MI 48109. Electronic address: johnstob@med.umich.edu.
Jacob RotmenschRush-Presbyterian St. Lukes Med. Center; Chicago, IL 60612. Electronic address: jacob_rotmensch@rush.edu.
Iowa City Public Library · USMedStar Franklin Square Medical Center · USNRG Oncology · USTexas Health Dallas · USThe University of Texas MD Anderson Cancer Center · USUniversity of Michigan–Ann Arbor · USUniversity of Tulsa · USWashington University in St. Louis · 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
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
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI BLESSING, JOHN A · 1985 to 2013
$67.4M
GYNECOLOGIC ONCOLOGY GROUPU10CA101165 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 2003 to 2014
$43.1M
UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP) UG1UG1CA233329 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KELLY K HUNT, CHELSEA Camille PINNIX · 2019 to 2026
$11.1M
Washington University/ Siteman Cancer Center Lead Academic SiteU10CA180833 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L, KOZOWER, BENJAMIN D · 2014 to 2018
$7.6M
UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP)U10CA180858 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HUNT, KELLY K, PINNIX, CHELSEA CAMILLE · 2014 to 2018
$5.6M
NCI NIH HHS 1 U10 CA180822NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA101165NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180858NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233329
6 · The paper itself

Abstract

backgroundActivation of the mitogen activated protein kinase pathway plays a pivotal role in cell proliferation and is frequently activated in endometrial cancer. We sought to evaluate the efficacy/safety of selumetinib, a selective MEK-1/2 inhibitor in women with recurrent endometrial cancer.

methodsThis was a phase II, single-arm, open-label study evaluating response and 6-month event-free survival (EFS) as primary endpoints. Eligible patients had measurable disease, 1-2 prior cytotoxic regimens, and performance status 0-2. Selumetinib 75mg PO BID was administered daily until progression or intolerance. One cycle was 28days.

resultsFifty-four patients were enrolled; 2 were excluded due to improper pre-study treatment (1) and never treated (1), leaving 52 evaluable for efficacy/safety. Median age was 62; histology included endometrioid (58%), serous (17%) and mixed (23%). Seventeen patients (33%) had 2 prior cytotoxic regimens. The median number of cycles administered was 2 (1-34). Three (6%) patients had objective response (1 CR, 2 PR); 13 had SD as best response. The proportion of patients with 6-month EFS was 12%. Median EFS, progression-free and overall survival was 2.1, 2.3, and 8.5months, respectively. Drug-attributed grade 3/4 adverse events were observed (≥5%) were fatigue (15%), anemia (10%), pain (10%), extremity edema (8%), and dyspnea (6%). There was 1 grade 4 infection (renal), 1 grade 4 anemia, and 1 death due to hemorrhage (rectum).

conclusionsSelumetinib was tolerable in this population but did not meet pre-trial specifications for clinical efficacy.

Indexed as

Administration, OralAdultAgedAged, 80 and overBenzimidazolesDrug Administration ScheduleEndometrial NeoplasmsFemaleHumansKaplan-Meier EstimateMAP Kinase Kinase 1MAP Kinase Kinase 2Middle AgedNeoplasm Recurrence, LocalProtein Kinase InhibitorsAZD 6244BenzimidazolesMAP2K1 protein, humanMAP2K2 protein, humanMAP Kinase Kinase 1MAP Kinase Kinase 2Protein Kinase Inhibitorsendometrial cancerMEK inhibitorPhase II trialSelumetinibtoxicity

Identifiers

PMID25887099
PMCPMC4469526
OpenAlexW2047630282

What OpenQuestion holds

Textmetadata
LicenceTDM
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.