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Fleeman N, Saborido CM, Payne K, et al. The Clinical Effectiveness and Cost-Effectiveness of Genotyping for CYP2D6 for the Management of Women with Breast Cancer Treated with Tamoxifen: A Systematic Review. Southampton (UK): NIHR Journals Library; 2011 Sep. (Health Technology Assessment, No. 15.33.)

Cover of The Clinical Effectiveness and Cost-Effectiveness of Genotyping for CYP2D6 for the Management of Women with Breast Cancer Treated with Tamoxifen: A Systematic Review

The Clinical Effectiveness and Cost-Effectiveness of Genotyping for CYP2D6 for the Management of Women with Breast Cancer Treated with Tamoxifen: A Systematic Review.

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Appendix 2Table of excluded studies with rationale

Excluded studies from clinical review

The following citations were excluded at screening stage 2:

StudyReason for exclusion
Bijl et al. 200955,56Includes mostly patients with metastatic disease (≥ 75%) (Bijl et al. 200955 is a conference abstract)
Boocock et al. 200257Wrong outcome (N-desmethyl-TAM, not endoxifen)
Burton 200658Not a research study (description of Goetz et al. 200584)
Chubak et al. 200859Does not consider outcomes by CYP2D6 genotype
Coller 200360Not a primary research study (review)
Connolly et al. 200761Does not consider outcomes by CYP2D6 genotype
Crewe et al. 200262PK study that does not consider endoxifen
Desta et al. 200463PK study that does not consider endoxifen
Dezentje et al. 200864Not a primary research study (review, subsequently published in 2009142)
Dieudonne et al. 200965Wrong outcome (changes in follicle-stimulating hormone and sex hormone-binding globulin)
aGoetz et al. 2006,66 200867Does not consider outcomes by CYP2D6 genotype (index including HOXB13/IL17BR) (Goetz et al. 200666 is interim analysis presented as abstract)
Grabinski et al. 200668Wrong outcome (plasma levels of TAM and 4-hydroxytamoxifen, not endoxifen)
Johnson et al. 200470Does not link endoxifen to clinical outcomes
Does not consider endoxifen plasma levels by CYP2D6 genotype
Lash et al. 200871Does not consider outcomes by CYP2D6 genotype
aLim et al. 200672Does not link endoxifen to clinical outcomesa
Does not consider endoxifen plasma levels by CYP2D6 genotypea
aLim et al. 200773Includes only patients with metastatic disease in efficacy studya
aMortimer et al. 200874Does not consider outcomes by CYP2D6 genotype
aNtukidem et al. 200875Wrong outcome (serum total cholesterol)
Ro et al. 200876Single case reports
Serrano et al. 200977Wrong outcome (plasma levels of N-desmethyl-TAM, not endoxifen)
Wrong setting (chemoprevention)
Sridar et al. 200278PK study that does not consider endoxifen or CYP2D6
Veenstra et al. 200979Not a primary research study (economic analysis)
Wu et al. 200980 and Hawse et al. 200881Does not link endoxifen to clinical outcomes (considers metabolism of endoxifen in vitro) (Hawse et al. 200881 is interim analysis presented as conference abstract)

PK, pharmacokinetics.

a

Data on relevant outcomes from the cohort of patients included this study is included, however, in separate publications that have been included in the review.

In addition, one of the included citations by Lim et al.73 also included data on an efficacy study containing only patients with metastatic disease. These data were excluded from the review, but as the citation also included data on a separate pharmacokinetic study of patients with early and metastatic breast cancer, this citation is included in the review.

Excluded studies from economics review

StudyReason for exclusion
Anderson et al. 2006143Does not consider CYP2D6 testing
Annemans 2008144Does not consider CYP2D6 testing
Armstrong et al. 2001145Does not consider CYP2D6 testing
Benedict and Brown 2005146Does not consider CYP2D6 testing
BlueCross BlueShield 2001147Does not consider CYP2D6 testing
Borgstrom et al. 2004148Does not consider CYP2D6 testing
Cuzick et al. 2006149Does not consider CYP2D6 testing
Delea et al. 2006150Does not consider CYP2D6 testing
Delea et al. 2007124Does not consider CYP2D6 testing
Delea et al. 2008123Does not consider CYP2D6 testing
Dranitsaris et al. 2003151Does not consider CYP2D6 testing
Duelge and Hillner 2000152Does not consider CYP2D6 testing
Dunn and Keam 2006153Does not consider CYP2D6 testing
Eckermann et al. 2003154Does not consider CYP2D6 testing
Eisinger 2008155Not an economic evaluation
El Ouagari et al. 2007125Does not consider CYP2D6 testing
aFleeman et al. 201045Not related to breast cancer
Gil et al. 2006156Does not consider CYP2D6 testing
Goeree et al. 2006157Does not consider CYP2D6 testing
Hershman et al. 2002158Does not consider CYP2D6 testing
Higa 2000159Does not consider CYP2D6 testing
Higa 2001160Does not consider CYP2D6 testing
Hillner and Radice 2001161Does not consider CYP2D6 testing
Hillner 2004162Does not consider CYP2D6 testing
Hind et al. 200730Does not consider CYP2D6 testing
Imai et al. 2007163Does not consider CYP2D6 testing
Kanis et al. 2005164Does not consider CYP2D6 testing
Karnon and Jones 2003165Does not consider CYP2D6 testing
Karnon et al. 2003166Does not consider CYP2D6 testing
Karnon 2006126Does not consider CYP2D6 testing
Karnon et al. 2006167Does not consider CYP2D6 testing
Karnon et al. 2008168Does not consider CYP2D6 testing
Keyzer et al. 2005169Does not consider CYP2D6 testing
Kellokumpu-Lehtinen et al. 2007170Does not consider CYP2D6 testing
Kilian and Porzsolt 2005171Does not consider CYP2D6 testing
Lindgren et al. 2002172Does not consider CYP2D6 testing
Locker et al. 2007173Does not consider CYP2D6 testing
Lonning 2006174Does not consider CYP2D6 testing
Lundkvist et al. 2007175Does not consider CYP2D6 testing
Mansel et al. 2007176Does not consider CYP2D6 testing
Marchetti et al. 2004177Does not consider CYP2D6 testing
Meadows et al. 2007178Does not consider CYP2D6 testing
Melnikow et al. 2008179Does not consider CYP2D6 testing
Miller et al. 2007180Does not consider CYP2D6 testing
Moeremans and Annemans 2006181Does not consider CYP2D6 testing
Mullins and Ohsfeldt 2003182Does not consider CYP2D6 testing
Naeim and Keeler 2005183Does not consider CYP2D6 testing
NICE 2006184Does not consider CYP2D6 testing
Okubo et al. 2005185Does not consider CYP2D6 testing
Ozanne and Esserman 2004186Does not consider CYP2D6 testing
Punglia et al. 2008119Includes CYP2D6 testing but does not include costs
Risebrough et al. 2007187Does not consider CYP2D6 testing
Rocchi and Verma 2006188Does not consider CYP2D6 testing
Rodriguez-Antona et al. 2009189Not related to breast cancer
Sher et al. 2009190Does not consider CYP2D6 testing
Simons et al. 2003191Does not consider CYP2D6 testing
Skedgel et al. 2007192Does not consider CYP2D6 testing
Skedgel et al. 2007193Does not consider CYP2D6 testing
Smith and Hillner 2000194Does not consider CYP2D6 testing
Thompson et al. 2007195Does not consider CYP2D6 testing
Veenstra et al. 200979Includes CYP2D6 testing but does not include costs
Williams et al. 2006196Does not consider CYP2D6 testing
Younis et al. 2007197Does not consider CYP2D6 testing
a

When the search was conducted, this review was ‘in press’.

Ongoing studies

One study appears to meet inclusion criteria of this review, but has not yet reported:

StudyOutcomes to be measured
Irvin et al. 200969,198Change in endoxifen levels after an increase in the TAM dose from 20 to 40 mg in patients with CYP2D6 IM genotypes

Tolerability of increasing the dose of TAM from 20 to 40 mg per day in patients with CYP2D6 IM genotypes

Feasibility of obtaining pharmacogenomic information from patients in the clinical setting and using it to guide changes in therapy

CYP2D6 allele frequencies and endoxifen levels among African American women taking TAM

Change in plasma endoxifen levels after an increase in TAM dose from 20 to 40 mg daily in patients with poor-metabolising genotypes

Another ongoing study may be of interest regarding clinical utility:

StudyStudy details
Lorizio et al. 2009115Patients taking TAM, or for whom TAM was recommended, participate in a teaching session that discusses both positive and negative results regarding CYP2D6 genotype and breast cancer recurrence. CYP2D6 testing offered to all participants at the end of the session; results then released to their clinician. Clinicians informed of test results but no specific treatment recommendation provided. To determine whether or not a change in medication occurred, a follow-up phone call is conducted 4–6 months later. To date, 180 women have been enrolled, 100 have received the follow-up call, of which five were classified PM. Of these, four (80%) have had their treatment changed based on physician recommendation compared with 10 (11%) in IM or EM (p = 0.001)
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Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK99693

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