Evidence map›Paper›PMID 33767162›Full record

ArticleNPJ breast cancer2021

Association of CYP2D6 genotype and tamoxifen metabolites with breast cancer recurrence in a low-dose trial.

Andrea DeCensi, Harriet Johansson, Thomas Helland, Matteo Puntoni, Debora Macis, Valentina Aristarco, Silvia Caviglia, Tania Buttiron Webber, Irene Maria Briata, Mauro D'Amico and 8 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in NPJ breast cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01357772 (Randomized Placebo-controlled Phase III Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 18% 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.

NCT01357772 phase3active not recruitingnot on this map

Randomized Placebo-controlled Phase III Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up

TypeinterventionalSponsorAndrea DeCensiRan2008 to 2028Enrolled500ConditionsCarcinoma, Intraductal, Noninfiltrating, Recurrence, Local Neoplasm, Breast Neoplasms, Atypical HyperplasiaArmsTamoxifen, placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Tamoxifen evolution.British journal of cancer · 2023
    Review
  5. Moving Pharmacogenetics Into Practice: It's All About the Evidence!Clinical pharmacology and therapeutics · 2021
    Review
  6. Article
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

18 authors at 6 institutions in 2 countries.

Andrea DeCensiDivision of Medical Oncology, E.O. Galliera Hospital, Genoa, Italy. andrea.decensi@galliera.it.ORCID http://orcid.org/0000-0003-2635-4491
Harriet JohanssonDivision of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.ORCID http://orcid.org/0000-0002-4131-2030
Thomas HellandHormone Laboratory, Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway.ORCID http://orcid.org/0000-0002-8681-9601
Matteo PuntoniClinical Trial Unit, Office of the Scientific Director, E.O. Galliera Hospital, Genoa, Italy.
Debora MacisDivision of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.ORCID http://orcid.org/0000-0002-0633-2933
Valentina AristarcoDivision of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Silvia CavigliaDivision of Medical Oncology, E.O. Galliera Hospital, Genoa, Italy.
Tania Buttiron WebberDivision of Medical Oncology, E.O. Galliera Hospital, Genoa, Italy.
Irene Maria BriataDivision of Medical Oncology, E.O. Galliera Hospital, Genoa, Italy.
Mauro D'AmicoDivision of Medical Oncology, E.O. Galliera Hospital, Genoa, Italy.
Davide SerranoDivision of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Aliana Guerrieri-GonzagaDivision of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Ersilia BifulcoDepartment of Clinical Science, University of Bergen, Bergen, Norway.
Steinar HustadDepartment of Clinical Science, University of Bergen, Bergen, Norway.
Håvard SøilandDepartment of Clinical Science, University of Bergen, Bergen, Norway.ORCID http://orcid.org/0000-0002-9285-2774
Luca BoniIRCCS San Martino Hospital, Genoa, Italy.ORCID http://orcid.org/0000-0003-2217-4047
Bernardo BonanniDivision of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, Milan, Italy.ORCID http://orcid.org/0000-0003-3589-2128
Gunnar MellgrenDepartment of Clinical Science, University of Bergen, Bergen, Norway.
Ente Ospedaliero Ospedali Galliera · ITEuropean Institute of Oncology · ITUniversity of Bergen · NOHaukeland University Hospital · NOOspedale Policlinico San Martino · ITStavanger University Hospital · NO

Funding

Associazione Italiana per la Ricerca sul Cancro (Italian Association for Cancer Research) IG 2008 Grant no. 5611Ministero della Salute (Ministry of Health, Italy) RFPS-2006-1-339898; Ricerca Corrente
6 · The paper itself

Abstract

Low-dose tamoxifen halves recurrence in non-invasive breast cancer without significant adverse events. Some adjuvant trials with tamoxifen 20 mg/day had shown an association between low endoxifen levels (9-16 nM) and recurrence, but no association with CYP2D6 was shown in the NSABP P1 and P2 prevention trials. We studied the association of CYP2D6 genotype and tamoxifen metabolites with tumor biomarkers and recurrence in a randomized phase III trial of low-dose tamoxifen. Median (IQR) endoxifen levels at year 1 were 8.4 (5.3-11.4) in patients who recurred vs 7.5 (5.1-10.2) in those who did not recur (p = 0.60). Tamoxifen and metabolites significantly decreased C-reactive protein (CRP, p < 0.05), and a CRP increase after 3 years was associated with higher risk of recurrence (HR = 4.37, 95% CI, 1.14-16.73, P = 0.03). In conclusion, endoxifen is below 9 nM in most subjects treated with 5 mg/day despite strong efficacy and there is no association with recurrence, suggesting that the reason for tamoxifen failure is not poor drug metabolism. Trial registration: ClinicalTrials.gov, Identifier: NCT01357772 .

Identifiers

PMID33767162
PMCPMC7994552
OpenAlexW3138269498

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.