Evidence map›Paper›PMID 21880792›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2011

Evaluation of CYP2D6 and efficacy of tamoxifen and raloxifene in women treated for breast cancer chemoprevention: results from the NSABP P1 and P2 clinical trials.

Matthew P Goetz, Daniel J Schaid, D Lawrence Wickerham, Stephanie Safgren, Taisei Mushiroda, Michiaki Kubo, Anthony Batzler, Joseph P Costantino, Victor G Vogel, Soonmyung Paik and 7 more

Erratum issuedOpen access · bronzeAbstract readClinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
5.8field-weighted citation impact, top 4% 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, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

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  7. The effect ofOncoTargets and therapy · 2017
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4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

17 authors at 7 institutions in 2 countries.

Matthew P GoetzDepartment of Oncology, Mayo Clinic, Rochester, Minnesota 55905, USA. goetz.matthew@mayo.edu
Daniel J Schaid
D Lawrence Wickerham
Stephanie Safgren
Taisei Mushiroda
Michiaki Kubo
Anthony Batzler
Joseph P Costantino
Victor G Vogel
Soonmyung Paik
Erin E Carlson
David A Flockhart
Norman Wolmark
Yusuke Nakamura
Richard M Weinshilboum
James N Ingle
Matthew M Ames
NSABP Foundation · USCancer Genetics (United States) · USUniversity of Pittsburgh · USAllegheny General Hospital · USIndiana University – Purdue University Indianapolis · USRIKEN Center for Integrative Medical Sciences · JPUniversity of Pittsburgh Medical Center · US

Funding

NSABP Foreign AccrualsU10CA037377 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI WOLMARK, NORMAN · 1985 to 2014
$116.5M
STUDY TO ASSESS RALOXIFENE FOR PREVENTING BREAST CANCERU10CA069974 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI COSTANTINO, JOSEPH P. · 1995 to 2013
$62.4M
The Role of CHFR in Tumorigenesis and Paclitaxel-Sensitivity in Breast CancerP50CA116201 · NCI · MAYO CLINIC ROCHESTER · PI PETER C LUCAS · 2005 to 2026
$49.9M
PHARMACOGENETICS OF PHASE II DRUG METABOLIZING ENZYMESU01GM061388 · NIGMS · MAYO CLINIC ROCHESTER · PI WEINSHILBOUM, RICHARD M. · 2000 to 2009
$15.7M
NCIC Foreign AccrualsU10CA077202 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI EISENHAUER, ELIZABETH · 1998 to 2013
$14.6M
NSABP Biological Specimen BanksU24CA114732 · NCI · NSABP FOUNDATION, INC. · PI WOLMARK, NORMAN · 2005 to 2014
$9.4M
Tamoxifen biotransformation pathway pharmacogenomicsR01CA133049 · NCI · MAYO CLINIC ROCHESTER · PI GOETZ, MATTHEW PHILIP · 2008 to 2013
$2.3M
The Johns Hopkins Folding MeetingR13GM063173 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI LATTMAN, EATON E · 2001 to 2001
$5k
NCI NIH HHS P50 CA116201NCI NIH HHS P50CA116201NCI NIH HHS R01 CA133049NCI NIH HHS U10 CA037377NCI NIH HHS U10 CA069974NCI NIH HHS U10 CA077202NCI NIH HHS U10CA37377NCI NIH HHS U10CA69974NCI NIH HHS U24 CA114732NCI NIH HHS U24CA114732NIGMS NIH HHS U01 GM061388NIGMS NIH HHS U01GM61388NIGMS NIH HHS U01GM63173PHS HHS U10C-A77202
6 · The paper itself

Abstract

backgroundControversy exists regarding the association between CYP2D6 enzyme activity and tamoxifen effectiveness in the adjuvant treatment of invasive breast cancer; however, this association in the primary prevention of breast cancer is unknown.

methodsWe conducted a nested case-control study in the context of the NSABP P1 and P2 prevention trials to determine the impact of CYP2D6 genotype, CYP2D6 inhibitor use, and metabolizer status (CYP2D6 genotype combined with CYP2D6 inhibitor use), on breast cancer events. Women who developed breast cancer (both noninvasive and invasive) while on 5 years of selective estrogen receptor modulators therapy (cases) were matched to controls free of breast cancer. Comprehensive CYP2D6 genotyping was conducted for alleles associated with absent (*3, *4, *5, and *6), reduced (*10, *17, and *41), and increased (*1XN and *2XN) enzyme activity. Information regarding the use of CYP2D6 inhibitors was recorded.

resultsA total of 591 cases were matched to 1,126 controls and DNA was genotyped in more than 97%. In patients treated with tamoxifen, there was no association of CYP2D6 genotype [OR (extensive/poor metabolizer): 0.90; 95% CI: 0.46-1.74, P = 0.74), use of a potent CYP2D6 inhibitor (OR 0.92; 95% CI: 0.575-1.486), or CYP2D6 metabolizer status (OR 1.03; 95% CI: 0.669-1.607) with breast cancer occurrence. Likewise, there was no association between any CYP2D6 metabolism parameter with breast cancer events in raloxifene-treated patients.

conclusionIn the NSABP P1 and P2 clinical trials, alterations in CYP2D6 metabolism are not associated with either tamoxifen or raloxifene efficacy.

Indexed as

AgedBreast NeoplasmsCase-Control StudiesCytochrome P-450 CYP2D6Cytochrome P-450 CYP2D6 InhibitorsFemaleHumansMiddle AgedPostmenopauseRaloxifene HydrochlorideTamoxifenCytochrome P-450 CYP2D6Cytochrome P-450 CYP2D6 InhibitorsRaloxifene HydrochlorideTamoxifen

Identifiers

PMID21880792
PMCPMC3207003
OpenAlexW2136249282

What OpenQuestion holds

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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.