Evidence map›Paper›PMID 28451964›Full record

Trial reportBreast cancer research and treatment2017

Prospective assessment of patient-reported outcomes and estradiol and drug concentrations in patients experiencing toxicity from adjuvant aromatase inhibitors.

Kunal C Kadakia, Kelley M Kidwell, Nicholas J Seewald, Claire F Snyder, Anna Maria Storniolo, Julie L Otte, David A Flockhart, Daniel F Hayes, Vered Stearns, N Lynn Henry

Abstract readClinical Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2017. 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
0.9field-weighted citation impact, top 22% 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, 12 citations in OpenAlex.

  1. Effects ofPharmacogenomics · 2019
    Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Observational
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 5 institutions in 1 country.

Kunal C KadakiaUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Kelley M KidwellDepartment of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.
Nicholas J SeewaldDepartment of Biostatistics, University of Michigan, Ann Arbor, MI, USA.
Claire F SnyderDivision of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Anna Maria StornioloMelvin and Bren Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN, USA.
Julie L OtteSchool of Nursing, Indiana University, Indianapolis, IN, USA.
David A FlockhartDivision of Clinical Pharmacology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
Daniel F HayesBreast Oncology Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.
Vered StearnsBreast Cancer Program, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
N Lynn HenryDivision of Oncology, Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope Dr. #3362, Salt Lake City, UT, 84112, USA. lynn.henry@hci.utah.edu.
Indiana University – Purdue University Indianapolis · USUniversity of Michigan–Ann Arbor · USJohns Hopkins University · USHuntsman Cancer Institute · USMichigan Center for Translational Pathology · US

Funding

ZINC GLUCONATE GLYCINE LOZENGES &VITAMIN C EFFECTS ON COMMON COLDM01RR000042 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ELSTROM, REBECCA L · 1985 to 2007
$40.8M
ZINC AND CA EDTA THERAPY OF PLUMBISMM01RR000052 · NCRR · JOHNS HOPKINS UNIVERSITY · PI MARSH, LAURA · 1985 to 2007
$37.3M
ZOSUQUIDAR TRIHYDROCHLORIDE DURING CONVENTIONAL INDUCTION AND POST-REMISSIONM01RR000750 · NCRR · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI STORNIOLO, ANNA · 1985 to 2008
$25.5M
TAMAXIFEN PHARMACOGENETICSU01GM061373 · NIGMS · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI FLOCKHART, DAVID ALASTAIR · 2000 to 2009
$17.0M
Indiana University Comprehensive Training in Clinical PharmacologyT32GM008425 · NIGMS · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI Zeruesenay Desta, Michael Thomas Eadon · 1992 to 2026
$7.7M
Biostatistics Training Program in Cancer ResearchT32CA083654 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Veerabhadran Baladandayuthapani, Kelley McLain Kidwell · 2002 to 2026
$4.3M
Research and Training for Behavioral Oncology InterventionsK05CA175048 · NCI · INDIANA UNIVERSITY INDIANAPOLIS · PI CHAMPION, VICTORIA LEE · 2014 to 2018
$484k
NCI NIH HHS K05 CA175048NCI NIH HHS T32 CA083654NCRR NIH HHS M01 RR000042NCRR NIH HHS M01 RR000052NCRR NIH HHS M01 RR000750NIGMS NIH HHS T32 GM008425NIGMS NIH HHS U01 GM061373
6 · The paper itself

Abstract

purposeAromatase inhibitors (AI), which decrease circulating estradiol concentrations in post-menopausal women, are associated with toxicities that limit adherence. Approximately one-third of patients will tolerate a different AI after not tolerating the first. We report the effect of crossover from exemestane to letrozole or vice versa on patient-reported outcomes (PROs) and whether the success of crossover is due to lack of estrogen suppression.

methodsPost-menopausal women enrolled on a prospective trial initiating AI therapy for early-stage breast cancer were randomized to exemestane or letrozole. Those that discontinued for intolerance were offered protocol-directed crossover to the other AI after a washout period. Changes in PROs, including pain [Visual Analog Scale (VAS)] and functional status [Health Assessment Questionnaire (HAQ)], were compared after 3 months on the first versus the second AI. Estradiol and drug concentrations were measured.

resultsEighty-three patients participated in the crossover protocol, of whom 91.3% reported improvement in symptoms prior to starting the second AI. Functional status worsened less after 3 months with the second AI (HAQ mean change AI #1: 0.2 [SD 0.41] vs. AI #2: -0.05 [SD 0.36]; p = 0.001); change in pain scores was similar between the first and second AI (VAS mean change AI #1: 0.8 [SD 2.7] vs. AI #2: -0.2 [SD 2.8]; p = 0.19). No statistical differences in estradiol or drug concentrations were found between those that continued or discontinued AI after crossover.

conclusionsAlthough all AIs act via the same mechanism, a subset of patients intolerant to one AI report improved PROs with a different one. The mechanism of this tolerance remains unknown, but does not appear to be due to non-adherence to, or insufficient estrogen suppression by, the second AI.

Indexed as

AdultAgedAged, 80 and overAndrostadienesAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantCross-Over StudiesEstradiolFemaleHumansLetrozoleMiddle AgedNitrilesPatient Reported Outcome MeasuresProspective StudiesAndrostadienesAromatase InhibitorsEstradiolexemestaneLetrozoleNitrilesTriazolesAromatase inhibitorsArthralgiaCrossoverPatient outcome assessmentQuality of life

Identifiers

PMID28451964
PMCPMC5517133
OpenAlexW2608008235

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.