Evidence map›Paper›PMID 23053261›Full record

ArticleCancer chemotherapy and pharmacology2013

Phase I trial of exemestane in combination with metformin and rosiglitazone in nondiabetic obese postmenopausal women with hormone receptor-positive metastatic breast cancer.

Francisco J Esteva, Stacy L Moulder, Ana M Gonzalez-Angulo, Joe Ensor, James L Murray, Marjorie C Green, Kimberly B Koenig, Mong-Hong Lee, Gabriel N Hortobagyi, Sai-Ching Yeung

Open access · greenAbstract readClinical Trial, Phase IComparative Study
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.0field-weighted citation impact, top 13% 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

18 citing papers in PubMed, 33 citations in OpenAlex.

  1. Trial
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  10. Melatonin May Increase Anticancer Potential of Pleiotropic Drugs.International journal of molecular sciences · 2018
    Review
  11. Article
  12. Metformin, Diabetes, and Survival among U.S. Veterans with Colorectal Cancer.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2016
    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

10 authors at 1 institution in 1 country.

Francisco J EstevaDepartment of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. fjesteva@mdanderson.org
Stacy L Moulder
Ana M Gonzalez-Angulo
Joe Ensor
James L Murray
Marjorie C Green
Kimberly B Koenig
Mong-Hong Lee
Gabriel N Hortobagyi
Sai-Ching Yeung
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
U OF TEXAS HLTH SCI CTR HOUSTON CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCESUL1RR024148 · NCRR · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2006 to 2010
$27.9M
NCI NIH HHS CA016672NCI NIH HHS P30 CA016672NCRR NIH HHS UL1 RR024148
6 · The paper itself

Abstract

purposeObese women with breast cancer have worse prognosis than women with normal body mass index. Endocrine therapy resistance is in part mediated by insulin resistance in obese women with breast cancer. We investigated the tolerability and pharmacokinetics of exemestane in combination with metformin and rosiglitazone in nondiabetic overweight and obese postmenopausal women with hormone receptor-positive metastatic breast cancer.

methodsPatients had previously received chemotherapy and endocrine therapy for breast cancer. Exemestane was given as 25 mg orally per day. Metformin (M) and rosiglitazone (R) were given twice daily. Dose level 1 consisted of M 1,500 mg/day and R 6 mg/day. Dose level 2 consisted of M 2,000 mg/day and R 8 mg/day. Plasma concentrations of exemestane were measured on days 1, 8, and 15.

resultsTwenty patients were enrolled. Fourteen patients received exemestane, metformin, and rosiglitazone. Six patients received exemestane with metformin only (2,000 mg/day). Both regimens were well tolerated at the highest doses tested, and there were no notable changes in plasma exemestane levels. Six patients (30%) had stable disease for 6 months or longer.

conclusionsOral daily administration of exemestane (25 mg) and metformin (2,000 mg) with and without rosiglitazone (8 mg) daily was well tolerated. Exemestane pharmacokinetics were not altered by metformin and rosiglitazone.

Indexed as

Administration, OralAgedAndrostadienesAntineoplastic AgentsBreast NeoplasmsDose-Response Relationship, DrugDrug Therapy, CombinationFemaleHumansMetforminMiddle AgedObesityOverweightPostmenopauseRosiglitazoneThiazolidinedionesAndrostadienesAntineoplastic AgentsexemestaneMetforminRosiglitazoneThiazolidinediones

Identifiers

PMID23053261
PMCPMC3536885
OpenAlexW2090521829

What OpenQuestion holds

Texttitle and abstract
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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.