Document Detail


Factor V Leiden mutation and thromboembolism risk in women receiving adjuvant tamoxifen for breast cancer.
MedLine Citation:
PMID:  20554945     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Tamoxifen use has been associated with increased risk of thromboembolic events (TEs) in women with breast cancer and women at high risk for the disease. Factor V Leiden (FVL) is the most common inherited clotting factor mutation and also confers increased thrombosis risk. We investigated whether FVL was associated with TE risk in women with early-stage breast cancer who took adjuvant tamoxifen.
METHODS: A case-control study was conducted among 34 Cancer and Leukemia Group B (CALGB) institutions. We matched each of 124 women who had experienced a documented TE while taking adjuvant tamoxifen for breast cancer (but who were not necessarily on a CALGB treatment trial) to two control subjects (women who took adjuvant tamoxifen but did not experience TE) by age at diagnosis (+/-5 years). DNA from blood was analyzed for FVL mutations. Conditional logistic regression was used to estimate odds ratios (ORs) and to evaluate other potential factors associated with TE and tamoxifen use. All P values are based on two-sided tests.
RESULTS: FVL mutations were identified in 23 (18.5%) case and 12 (4.8%) control subjects (OR = 4.66, 95% confidence interval = 2.14 to 10.14, P < .001). In the multivariable model, FVL mutation was associated with TE (OR = 4.73, 95% confidence interval = 2.10 to 10.68, P < .001). Other statistically significant factors associated with TE risk were personal history of TE and smoking.
CONCLUSIONS: Among women taking adjuvant tamoxifen for early-stage breast cancer, those who had a TE were nearly five times more likely to carry a FVL mutation than those who did not have a TE. Postmenopausal women should be evaluated for the FVL mutation before prescription of adjuvant tamoxifen if a positive test would alter therapeutic decision making.
Authors:
Judy E Garber; Susan Halabi; Sara M Tolaney; Ellen Kaplan; Laura Archer; James N Atkins; Stephen Edge; Charles L Shapiro; Lynn Dressler; Electra D Paskett; Electra M Paskett; Gretchen Kimmick; James Orcutt; Anthony Scalzo; Eric Winer; Ellis Levine; Nasir Shahab; Nancy Berliner;
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2010-06-16
Journal Detail:
Title:  Journal of the National Cancer Institute     Volume:  102     ISSN:  1460-2105     ISO Abbreviation:  J. Natl. Cancer Inst.     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-07-07     Completed Date:  2010-07-14     Revised Date:  2011-08-01    
Medline Journal Info:
Nlm Unique ID:  7503089     Medline TA:  J Natl Cancer Inst     Country:  United States    
Other Details:
Languages:  eng     Pagination:  942-9     Citation Subset:  IM    
Affiliation:
Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115, USA. judy_garber@dfci.harvard.edu
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MeSH Terms
Descriptor/Qualifier:
Aged
Antineoplastic Agents, Hormonal / administration & dosage,  adverse effects*
Breast Neoplasms / drug therapy*
Case-Control Studies
Chemotherapy, Adjuvant
Estrogen Receptor Modulators / administration & dosage,  adverse effects*
Factor V / genetics*
Female
Humans
Logistic Models
Middle Aged
Multivariate Analysis
Mutation*
Odds Ratio
Prevalence
Risk Factors
Selective Estrogen Receptor Modulators / adverse effects
Smoking / adverse effects
Tamoxifen / administration & dosage,  adverse effects*
Thromboembolism / chemically induced,  etiology*,  genetics,  prevention & control
Grant Support
ID/Acronym/Agency:
CA02599/CA/NCI NIH HHS; CA03927/CA/NCI NIH HHS; CA04457/CA/NCI NIH HHS; CA12046/CA/NCI NIH HHS; CA12449/CA/NCI NIH HHS; CA21060/CA/NCI NIH HHS; CA31946/CA/NCI NIH HHS; CA32291/CA/NCI NIH HHS; CA33601/CA/NCI NIH HHS; CA35113/CA/NCI NIH HHS; CA37447/CA/NCI NIH HHS; CA41287/CA/NCI NIH HHS; CA45389/CA/NCI NIH HHS; CA45418/CA/NCI NIH HHS; CA45808/CA/NCI NIH HHS; CA47577/CA/NCI NIH HHS; CA47642/CA/NCI NIH HHS; CA60138/CA/NCI NIH HHS; CA77406/CA/NCI NIH HHS; CA77597/CA/NCI NIH HHS; CA77658/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
0/Antineoplastic Agents, Hormonal; 0/Estrogen Receptor Modulators; 0/Selective Estrogen Receptor Modulators; 0/factor V Leiden; 10540-29-1/Tamoxifen; 9001-24-5/Factor V
Comments/Corrections
Comment In:
J Natl Cancer Inst. 2010 Jul 7;102(13):918-9   [PMID:  20554943 ]
Erratum In:
J Natl Cancer Inst. 2010 Aug 4;102(15):1210
Note: Paskett, Electra M [corrected to Paskett, Electra D]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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