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

• The risk ratio of tamoxifen-associated venous thromboembolism in breast cancer patients is from 2.4 to 7.1.
• VTE complicates the clinical condition and causes a change of the breast cancer treatment.
• The association of the FV Leiden mutation with VTE risk during adjuvant tamoxifen is disputable.
• The predictive model for risk assessment of VTE in cancer patients includes Factor VIII activity.

BackgroundEstimates 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.MethodsThe 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.ResultsIn 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 > 1.5 IU/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.ConclusionThe 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.