Evidence map›Paper›PMID 20681032›Full record

Trial reportCancer2010

A phase 2 study of the oral mammalian target of rapamycin inhibitor, everolimus, in patients with recurrent endometrial carcinoma.

Brian M Slomovitz, Karen H Lu, Taren Johnston, Robert L Coleman, Mark Munsell, Russell R Broaddus, Cheryl Walker, Lois M Ramondetta, Thomas W Burke, David M Gershenson and 1 more

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 99 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 4 pooled it
11.5field-weighted citation impact, top 1% 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

99 citing papers in PubMed, 4 syntheses or guidelines pooled it, 276 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. 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
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. 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
  10. Trial
  11. The search continues: looking for predictive biomarkers for response to mammalian target of rapamycin inhibition in endometrial cancer.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2014
    Trial
  12. Trial
  13. Trial
  14. Trial
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  16. Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2011
    Trial
  17. Article
  18. Article
  19. Article
  20. Review

39 more citing papers are in PubMed but not listed here.

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 at 1 institution in 1 country.

Brian M SlomovitzDepartment of Gynecologic Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA. brian.slomovitz@atlantichealth.org
Karen H Lu
Taren Johnston
Robert L Coleman
Mark Munsell
Russell R Broaddus
Cheryl Walker
Lois M Ramondetta
Thomas W Burke
David M Gershenson
Judith Wolf
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundDysregulation of phosphatase and tensin homolog (PTEN) and the gene that encodes the p110α catalytic subunit of phosphatidylinositol-3-kinase (PI3K), PIK3CA, are the most common mutations in endometrial carcinoma (EC). Loss of PTEN or activation of PIK3CA results in constitutive activation of AKT, which leads to up-regulation of mammalian target of rapamycin (mTOR). Everolimus is an oral rapamycin analog that acts by selectively inhibiting mTOR.

methodsA single-institution, open-labeled, phase 2 study of everolimus in patients with measurable recurrent EC who had failed at least 1 and no more than 2 prior chemotherapeutic regimens was performed. Everolimus was administered at a dose of 10 mg orally daily for 28-day cycles. Patients were treated until disease progression or toxicity. The primary endpoint was clinical benefit response (CBR), defined as a confirmed complete or partial response or prolonged stable disease (SD) (≥8 weeks). Inclusion was limited to patients with endometrioid histology.

resultsA total of 35 patients were enrolled (median age, 58 years; range, 38-81 years). A total of 81 cycles were administered. Twelve of 28 (43%) evaluable patients had not developed disease progression at the time of the first objective evaluation (8 weeks). All these patients had SD (median, 4.5 cycles; range, 2-10 cycles). Six of the 28 (21%) patients had a confirmed CBR at 20 weeks of therapy. Patients with CBR discontinued treatment because of toxicity (6 patients), disease progression (5 patients), and noncompliance (1 patient). Seven patients were unevaluable after receiving ≤1 cycle because of toxicity (5 patients) or noncompliance (2 patients). The most common drug-related toxicities were fatigue, anemia, pain, lymphopenia, and nausea.

conclusionsEverolimus demonstrated encouraging single-agent CBR in pretreated patients with recurrent endometrioid EC. Future studies will evaluate this agent in combination with hormonal and/or cytotoxic therapy.

Indexed as

Administration, OralAdultAgedAged, 80 and overAntineoplastic AgentsEndometrial NeoplasmsEverolimusFemaleHumansMiddle AgedRecurrenceRetreatmentSirolimusTOR Serine-Threonine KinasesAntineoplastic AgentsEverolimusMTOR protein, humanSirolimusTOR Serine-Threonine Kinases

Identifiers

PMID20681032
PMCPMC5120730
OpenAlexW1975352300

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.