Factor V Leiden mutation and high FVIII are associated with an increased risk of VTE in women with breast cancer during adjuvant tamoxifen - results from a prospective, single center, case control study

Eur J Intern Med. 2015 Jan;26(1):63-7. doi: 10.1016/j.ejim.2014.12.015. Epub 2015 Jan 12.

Abstract

Background: Estimates of the risk ratio of tamoxifen-associated venous thromboembolism (VTE) in breast cancer patients range from 2.4 to 7.1. The occurrence of thrombosis in patients with breast cancer complicates the clinical condition and causes a change of treatment. Our study was conducted in order to investigate the influence of patient-related risk factors for thrombosis development in breast cancer patients whose treatment included adjuvant tamoxifen.

Methods: The prospective, single center, case control study included 150 breast cancer women, 50 whom developed venous thrombosis during adjuvant tamoxifen and 100 whom did not have thrombosis, as a control group. Patient-related risk factors such as: age, body mass index, previous VTE, varicose veins, concomitant diseases, the presence of prothrombotic mutations (FV Leiden, FII G20210A) and FVIII activity were evaluated in both groups.

Results: In respect of prothrombotic mutations, the FV Leiden mutation was present in a higher number of women from the VTE group (10/50 vs 7/100; P=0.020). Additionally, FVIII activity was significantly higher in the VTE group; median (IQR), of 1.79 (0.69) vs 1.45 (0.55); P<0.001 and more women in this group (24/50 vs 34/100) had increased FVIII activity; P=0.020. In those women with FVIII>1.5IU/ml, who were carriers of prothrombotic mutations, an OR of 3.76 (CI 95% 1.276-11.096; P=0.016) was obtained for VTE.

Conclusion: The results of our study showed that the factor V Leiden mutation and high FVIII are associated with an increased risk of VTE in women with breast cancer during adjuvant tamoxifen.

Keywords: Breast cancer; FV Leiden; Factor VIII; Tamoxifen; Venous thromboembolism.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activated Protein C Resistance / genetics*
  • Adult
  • Aged
  • Antineoplastic Agents, Hormonal / adverse effects*
  • Breast Neoplasms / drug therapy*
  • Carcinoma / drug therapy*
  • Carcinoma, Ductal, Breast / drug therapy
  • Carcinoma, Lobular / drug therapy
  • Carcinoma, Papillary / drug therapy
  • Case-Control Studies
  • Chemotherapy, Adjuvant
  • Factor V / genetics*
  • Factor VIII / metabolism*
  • Female
  • Genetic Predisposition to Disease
  • Humans
  • Middle Aged
  • Odds Ratio
  • Prospective Studies
  • Risk Factors
  • Tamoxifen / adverse effects*
  • Venous Thromboembolism / chemically induced*
  • Venous Thromboembolism / genetics

Substances

  • Antineoplastic Agents, Hormonal
  • factor V Leiden
  • Tamoxifen
  • Factor V
  • Factor VIII

Supplementary concepts

  • Thrombophilia due to Activated Protein C Resistance