Evidence map›Paper›PMID 31144152›Full record

ArticleBreast cancer research and treatment2019

Drug monitoring of tamoxifen metabolites predicts vaginal dryness and verifies a low discontinuation rate from the Norwegian Prescription Database.

Thomas Helland, Kari Britt Hagen, Martha Eimstad Haugstøyl, Jan Terje Kvaløy, Siri Lunde, Kirsten Lode, Ragna Anne Lind, Birgitta Haga Gripsrud, Kristin Jonsdottir, Jennifer Gjerde and 9 more

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Article in Breast cancer research and treatment, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% 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, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
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  6. The lived experience of patients with breast cancer on adjuvant endocrine therapy: side effects and coping strategies during the first year of medication initiation.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
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  12. Observational
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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

19 authors at 4 institutions in 1 country.

Thomas HellandHormone Laboratory, Haukeland University Hospital, 5020, Bergen, Norway.
Kari Britt HagenDepartment of Clinical Science, University of Bergen, Bergen, Norway.
Martha Eimstad HaugstøylHormone Laboratory, Haukeland University Hospital, 5020, Bergen, Norway.
Jan Terje KvaløyDepartment of Mathematics and Natural Science, University of Stavanger, Stavanger, Norway.
Siri LundeDepartment of Breast and Endocrine Surgery, Stavanger University Hospital, Stavanger, Norway.
Kirsten LodeDepartment of Research, Stavanger University Hospital, Stavanger, Norway.
Ragna Anne LindDepartment of Clinical Science, University of Bergen, Bergen, Norway.
Birgitta Haga GripsrudDepartment of Caring and Ethics, Faculty of Health Sciences, University of Stavanger, Stavanger, Norway.
Kristin JonsdottirDepartment of Breast and Endocrine Surgery, Stavanger University Hospital, Stavanger, Norway.
Jennifer GjerdeHormone Laboratory, Haukeland University Hospital, 5020, Bergen, Norway.
Ersilia BifulcoDepartment of Clinical Science, University of Bergen, Bergen, Norway.
Steinar HustadDepartment of Clinical Science, University of Bergen, Bergen, Norway.
Janne JonassenDepartment of Breast and Endocrine Surgery, Stavanger University Hospital, Stavanger, Norway.
Turid AasDepartment of Breast and Endocrine Surgery, Haukeland University Hospital, Bergen, Norway.
Tone Hoel LendeDepartment of Breast and Endocrine Surgery, Stavanger University Hospital, Stavanger, Norway.
Ernst Asbjørn LienHormone Laboratory, Haukeland University Hospital, 5020, Bergen, Norway.
Emiel Adrianus Maria JanssenDepartment of Mathematics and Natural Science, University of Stavanger, Stavanger, Norway.
Håvard Søiland *Department of Clinical Science, University of Bergen, Bergen, Norway.
Gunnar Mellgren *Hormone Laboratory, Haukeland University Hospital, 5020, Bergen, Norway. gunnar.mellgren@uib.no.ORCID http://orcid.org/0000-0001-6282-4986
Stavanger University Hospital · NOHaukeland University Hospital · NOUniversity of Bergen · NOUniversity of Stavanger · NO

Funding

Western Norway Health Authority 507074Western Norway Health Authority F-11314
6 · The paper itself

Abstract

purposeTamoxifen is an important targeted endocrine therapy in breast cancer. However, side effects and early discontinuation of tamoxifen remains a barrier for obtaining the improved outcome benefits of long-term tamoxifen treatment. Biomarkers predictive of tamoxifen side effects remain unidentified. The objective of this prospective population-based study was to investigate the value of tamoxifen metabolite concentrations as biomarkers for side effects. A second objective was to assess the validity of discontinuation rates obtained through pharmacy records with the use of tamoxifen drug monitoring.

methodsLongitudinal serum samples, patient-reported outcome measures and pharmacy records from 220 breast cancer patients were obtained over a 6-year period. Serum concentrations of tamoxifen metabolites were measured by LC-MS/MS. Associations between metabolite concentrations and side effects were analyzed by logistic regression and cross table analyses. To determine the validity of pharmacy records we compared longitudinal tamoxifen concentrations to discontinuation rates obtained through the Norwegian Prescription database (NorPD). Multivariable Cox regression models were performed to identify predictors of discontinuation.

resultsAt the 2nd year of follow-up, a significant association between vaginal dryness and high concentrations of tamoxifen, Z-4'-OHtam and tam-NoX was identified. NorPD showed a tamoxifen-discontinuation rate of 17.9% at 5 years and drug monitoring demonstrated similar rates. Nausea, vaginal dryness and chemotherapy-naive status were significant risk factors for tamoxifen discontinuation.

conclusionsThis real-world data study suggests that measurements of tamoxifen metabolite concentrations may be predictive of vaginal dryness in breast cancer patients and verifies NorPD as a reliable source of adherence data.

Indexed as

Drug MonitoringAdultAgedAged, 80 and overAntineoplastic Agents, HormonalBiomarkersBreast NeoplasmsChromatography, LiquidFemaleHumansMedication AdherenceMiddle AgedPatient Reported Outcome MeasuresPrognosisSurveys and QuestionnairesTamoxifenAntineoplastic Agents, HormonalBiomarkersTamoxifenAdherenceDiscontinuationEndocrine therapyMetabolismSide effectsTamoxifen

Identifiers

PMID31144152
OpenAlexW2947639662

What OpenQuestion holds

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Registered trials

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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.