Evidence map›Paper›PMID 24456823›Full record

Trial reportGynecologic oncology2014

Temsirolimus with or without megestrol acetate and tamoxifen for endometrial cancer: a gynecologic oncology group study.

Gini F Fleming, Virginia L Filiaci, Brandon Marzullo, Richard J Zaino, Susan A Davidson, Michael Pearl, Vicky Makker, James J Burke, Susan L Zweizig, Linda Van Le and 5 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
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. Cited by 52 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 3 pooled it
7.0field-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

52 citing papers in PubMed, 3 syntheses or guidelines pooled it, 119 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Treatment-related fatigue with everolimus and temsirolimus in patients with cancer-a meta-analysis of clinical trials.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2015
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Phase II study of everolimus and letrozole in patients with recurrent endometrial carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
    Trial
  12. Review
  13. Review
  14. Review
  15. Article
  16. Evolving treatment paradigms in metastatic or recurrent low-grade endometrial cancer: When is hormonal-based therapy the preferred option?International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023
    Review
  17. Review
  18. Review
  19. Article
  20. Article
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

15 authors at 11 institutions in 1 country.

Gini F FlemingUniversity of Chicago, Chicago, IL 60637, United States. Electronic address: gfleming@medicine.bsd.uchicago.edu.
Virginia L FiliaciGynecologic Oncology Group Statistical & Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
Brandon MarzulloGynecologic Oncology Group Statistical & Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
Richard J ZainoHershey Medical Center, Medical Center of Pennsylvania State University, Hershey, PA 17033, United States.
Susan A DavidsonUniversity of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, CO 80045, United States.
Michael PearlStony Brook University Hospital, Stony Brook, NY 11794, United States.
Vicky MakkerMemorial Sloan-Kettering Cancer Center, New York, NY 10021, United States.
James J BurkeMemorial Medical Center, Savannah, GA 31404, United States.
Susan L ZweizigUMass Memorial Medical Center, Worcester, MA 01605, United States.
Linda Van LeUNC-Chapel Hill, Chapel Hill, NC 27599, United States.
Parviz HanjaniHanjani Institute for Gynecologic Oncology, Abington, PA 19001, United States.
Gordon DowneyGynecologic Oncology of West Michigan, Grand Rapids, MI 49546, United States.
Joan L WalkerUniversity of Oklahoma, Oklahoma City, OK 73190, United States.
Henry D ReyesUniversity of Iowa Hospitals and Clinics, Iowa City, IA 52242, United States.
Kimberly K LeslieUniversity of Iowa Hospitals and Clinics, Iowa City, IA 52242, United States.
Gynecologic Oncology Group · USUniversity of Iowa Hospitals and Clinics · USMemorial Medical Center · USMemorial Sloan Kettering Cancer Center · USOklahoma City University · USPennsylvania State University · USStony Brook University Hospital · USUMass Memorial Health Care · USUniversity of Chicago · USUniversity of Colorado Cancer Center · USUniversity of North Carolina at Chapel Hill · 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
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
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
Gynecologic Oncology Group Specimen BankingU24CA114793 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 2005 to 2014
$7.0M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
Targeted Therapy for Endometrial CancerR01CA099908 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI LESLIE, KIMBERLY K. · 2002 to 2023
$5.8M
NCTN Lead Academic Participating Sites ApplicationU10CA180838 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A · 2014 to 2018
$2.8M
NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS R01 CA099908NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180838NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA114793NCI NIH HHS UG1 CA233180
6 · The paper itself

Abstract

objectivesTo determine the response, toxicities, and progression free survival of a regimen of temsirolimus with or without hormonal therapy in the treatment of advanced, or recurrent endometrial carcinoma.

backgroundPreclinical evidence suggested that blockade of the PI3K/AKT/mTOR pathway might overcome resistance to hormonal therapy.

methodsWe performed a randomized phase II trial of intravenous temsirolimus 25mg weekly versus the combination of weekly temsirolimus with a regimen of megestrol acetate 80 mg bid for three weeks alternating with tamoxifen 20mg bid for three weeks in women with recurrent or metastatic endometrial carcinoma.

resultsThere were 71 eligible patients who received at least one dose of therapy with 21 of these treated on the combination arm which was closed early because of an excess of venous thrombosis, with 5 episodes of deep venous thrombosis (DVT) and 2 pulmonary emboli. There were three responses observed in that arm (14%). A total of 50 eligible patients were treated on the single agent arm with 3 episodes of DVT and 11 responses (22%). Response rates were similar in patients with prior chemotherapy (7 of 29; 24%) and those with no prior chemotherapy (4 of 21; 19%). Two of four patients with clear cell carcinoma responded.

conclusionsAdding the combination of megestrol acetate and tamoxifen to temsirolimus therapy did not enhance activity and the combination was associated with an excess of venous thrombosis. Temsirolimus activity was preserved in patients with prior adjuvant chemotherapy.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDrug Administration ScheduleEndometrial NeoplasmsFemaleHumansImmunohistochemistryMegestrol AcetateMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalSirolimusTamoxifenMegestrol AcetateSirolimusTamoxifentemsirolimusEndometrial cancerHormonal therapyMegestrol acetateTamoxifenTemsirolimus

Identifiers

PMID24456823
PMCPMC4063288
OpenAlexW1986896421

What OpenQuestion holds

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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.