Evidence map›Paper›PMID 26859101›Full record

Trial reportBritish journal of clinical pharmacology2016

Fulvestrant decreases anastrozole drug concentrations when taken concurrently by patients with metastatic breast cancer treated on SWOG study S0226.

Daniel L Hertz, William E Barlow, Kelley M Kidwell, Kathy S Albain, Ted A Vandenberg, Shaker R Dakhil, Nagendra R Tirumali, Robert B Livingston, Julie Gralow, Daniel F Hayes and 3 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
3.6field-weighted citation impact, top 8% 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

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Effects ofPharmacogenomics · 2023
    Article
  3. Review
  4. Review
  5. Article
  6. Review
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

13 authors at 11 institutions in 2 countries.

Daniel L HertzCollege of Pharmacy, University of Michigan, Ann Arbor, MI, USA.
William E BarlowSWOG Statistical Center, Seattle, WA, USA.
Kelley M KidwellUniversity of Michigan, School of Public Health, Ann Arbor, MI, USA.
Kathy S AlbainLoyola University Chicago Stritch School of Medicine, Maywood, IL, USA.
Ted A VandenbergLondon Health Sciences Center/National Cancer Institute of Canada Clinical, Trials Group, London, ON, Canada.
Shaker R DakhilWichita NCORP, Wichita, KS, USA.
Nagendra R TirumaliKaiser Permanente NCORP, Portland, OR, USA.
Robert B LivingstonArizona Cancer Center, University of Arizona, Tucson, AZ, USA.
Julie GralowSeattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, USA.
Daniel F HayesDivision of Hematology/Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Gabriel N HortobagyiUniversity of Texas, M.D. Anderson Cancer Center, Houston, TX, USA.
Rita S MehtaUniversity of California Irvine Medical Center, Chao Family Comprehensive, Cancer Center, Orange, CA, USA.
James M RaeDivision of Hematology/Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
University of Michigan–Ann Arbor · USArizona Oncology · USCancer Research And Biostatistics · USCancer Research Center · USKaiser Permanente Center for Health Research · USLondon Health Sciences Centre · CALoyola University Chicago · USMichigan Center for Translational Pathology · USThe University of Texas MD Anderson Cancer Center · USUniversity of California, Irvine Medical Center · USWichita Clinic · US

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
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
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
UM LAPs- U10 GrantU10CA180801 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ZALUPSKI, MARK M · 2014 to 2018
$3.7M
NCI NIH HHS U10 CA180801NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180858NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233329
6 · The paper itself

Abstract

aimsIn the SWOG S0226 trial the combination of anastrozole plus fulvestrant (n = 349) was superior to anastrozole alone (n = 345) in hormone receptor (HR)-positive metastatic breast cancer. Here we report a pharmacokinetic subset analysis investigating a possible drug interaction between anastrozole and fulvestrant.

methodsPost-menopausal patients with HR-positive metastatic breast cancer were randomized to anastrozole with or without concurrent fulvestrant. Blood samples were collected at 2, 4, 6 and 8 months, just prior to receiving the next dose of anastrozole and fulvestrant. Drug concentrations were measured via LC/MS-MS. Anastrozole concentration was compared in patients on anastrozole alone vs. patients on concomitant fulvestrant. Comparisons were made at each time point using parametric tests and over time using a linear mixed effects model.

resultsA total of 483 anastrozole concentration measurements were included, 224 samples from 64 patients on the anastrozole alone arm and 259 from 73 patients on the combination arm. The mean anastrozole concentration in the combination arm was significantly lower than that in the anastrozole alone arm at each sample collection time (all P < 0.01) and in the mixed effects model (an estimated difference of 9.85 ng ml(-1) (95% CI 5.69, 14.00 ng ml(-1) ), P < 0.001).

conclusionA significant pharmacokinetic drug interaction was detected, in which the addition of fulvestrant to anastrozole treatment decreased the trough anastrozole concentration. Further research is needed to verify whether this interaction affects treatment efficacy and to determine the pharmacological mechanism by which this interaction occurs.

Indexed as

AnastrozoleBreast NeoplasmsDrug InteractionsEstradiolFemaleFulvestrantHumansNitrilesTriazolesAnastrozoleEstradiolFulvestrantNitrilesTriazolesanastrozolebreast cancerdrug interactionfulvestrantpharmacokinetics

Identifiers

PMID26859101
PMCPMC4876171
OpenAlexW2262097139

What OpenQuestion holds

Textmetadata
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.