Evidence map›Paper›PMID 23213055›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2013

CYP2D6 metabolism and patient outcome in the Austrian Breast and Colorectal Cancer Study Group trial (ABCSG) 8.

Matthew P Goetz, Vera J Suman, Tanya L Hoskin, Michael Gnant, Martin Filipits, Stephanie L Safgren, Mary Kuffel, Raimund Jakesz, Margaretha Rudas, Richard Greil and 7 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03582865 (Genetic Study of CYP2D6 Enzyme and Therapeutic Drug Monitoring of Tamoxifen in Premenopausal Women With Breast Cancer), which is not on this map. Cited by 58 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 7 pooled it
17.1field-weighted citation impact, top 1% 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.

NCT03582865 unknown statusnot on this mapstarted 2019, after this paper: background citation

Genetic Study of CYP2D6 Enzyme and Therapeutic Drug Monitoring of Tamoxifen in Premenopausal Women With Breast Cancer

TypeobservationalSponsorAssiut UniversityRan2019 to 2020Enrolled100ConditionsBreast CancerArmsTamoxifen 20 mg
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 7 syntheses or guidelines pooled it, 129 citations in OpenAlex.

  1. CYP2D6 Phenotype and Breast Cancer Outcomes: A Bias Analysis and Meta-Analysis.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2025
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  15. Heterogeneity in precision oncology.Cambridge prisms. Precision medicine · 2024
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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

17 authors at 3 institutions in 1 country.

Matthew P GoetzDepartment of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. goetz.matthew@mayo.edu
Vera J Suman
Tanya L Hoskin
Michael Gnant
Martin Filipits
Stephanie L Safgren
Mary Kuffel
Raimund Jakesz
Margaretha Rudas
Richard Greil
Otto Dietze
Alois Lang
Felix Offner
Carol A Reynolds
Richard M Weinshilboum
Matthew M Ames
James N Ingle
Paracelsus Medical University · ATMedical University of Vienna · ATLandeskrankenhaus Feldkirch · AT

Funding

Tamoxifen biotransformation pathway pharmacogenomicsR01CA133049 · NCI · MAYO CLINIC ROCHESTER · PI GOETZ, MATTHEW PHILIP · 2008 to 2013
$2.3M
NCI NIH HHS 1R01CA133049-01NCI NIH HHS R01 CA133049
6 · The paper itself

Abstract

purposeControversy exists about CYP2D6 genotype and tamoxifen efficacy. EXPERIMENTAL

designA matched case-control study was conducted using the Austrian Breast and Colorectal Cancer Study Group Trial 8 (ABCSG8) that randomized postmenopausal women with estrogen receptor (ER)-positive breast cancer to tamoxifen for 5 years (arm A) or tamoxifen for 2 years followed by anastrozole for 3 years (arm B). Cases had disease recurrence, contralateral breast cancer, second non-breast cancer, or died. For each case, controls were identified from the same treatment arm of similar age, surgery/radiation, and tumor-node-metastasis (TNM) stage. Genotyping was conducted for alleles associated with no (PM; *3, *4, *6), reduced (IM; *10, and *41), and extensive (EM: absence of these alleles) CYP2D6 metabolism.

resultsThe common CYP2D6*4 allele was in Hardy-Weinberg equilibrium. In arm A during the first 5 years of therapy, women with two poor alleles [PM/PM: OR, 2.45; 95% confidence interval (CI), 1.05-5.73, P = 0.04] and women with one poor allele (PM/IM or PM/EM: OR, 1.67; 95% CI, 0.95-2.93; P = 0.07) had a higher likelihood of an event than women with two extensive alleles (EM/EM). In years 3 to 5 when patients remained on tamoxifen (arm A) or switched to anastrozole (arm B), PM/PM tended toward a higher likelihood of a disease event relative to EM/EM (OR, 2.40; 95% CI, 0.86-6.66; P = 0.09) among women on arm A but not among women on arm B (OR, 0.28; 95% CI, 0.03-2.30).

conclusionIn ABCSG8, the negative effects of reduced CYP2D6 metabolism were observed only during the period of tamoxifen administration and not after switching to anastrozole.

Indexed as

AgedAged, 80 and overAntineoplastic Agents, HormonalBreast NeoplasmsCase-Control StudiesCytochrome P-450 CYP2D6FemaleGene FrequencyGenotypeHumansMiddle AgedPhenotypePolymorphism, Single NucleotidePostmenopauseTreatment OutcomeAntineoplastic Agents, HormonalCytochrome P-450 CYP2D6

Identifiers

PMID23213055
PMCPMC3548984
OpenAlexW2122090386

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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.