The risk of venous thromboembolic disease associated with adjuvant hormone therapy for breast carcinoma

Deitcher, Steven R.; Gomes, Marcelo

doi:10.1002/cncr.20347

Cited by 161 publications

(86 citation statements)

References 104 publications

(133 reference statements)

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“…The magnitude of increase in risk of VTE we observed after beginning tamoxifen therapy was comparable to that in studies of women with early-stage breast cancer between 1989 and 1999, which report an excess risk of VTE events in women receiving tamoxifen between 1.5-fold and sevenfold. 30 Our results are also concordant with those from a large cohort of women from Denmark with early-stage breast cancer in which women treated with tamoxifen had a 3.5-fold higher risk of VTE than women receiving other treatments. 10 Previous research has found the influence of tamoxifen on risk of VTE to attenuate 1 to 2 years after beginning therapy, 10,31 possibly suggesting an adaptation of the hemostatic system to the procoagulant effects of tamoxifen.…”

Section: 2supporting

confidence: 88%

When are breast cancer patients at highest risk of venous thromboembolism? A cohort study using English health care data

Walker

West

Card

et al. 2016

Blood

103

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Key Points• Patients with breast cancer have a risk of VTE equivalent to 6% a year while undergoing chemotherapy and in the month after treatment.• Tamoxifen is associated with a risk of VTE equivalent to 2% a year, which is 4 times higher than the risk before starting therapy.Patients with breast cancer are at increased risk of venous thromboembolism (VTE), particularly in the peridiagnosis period. However, no previous epidemiologic studies have investigated the relative impact of breast cancer treatments in a time-dependent manner. We aimed to determine the impact of breast cancer stage, biology, and treatment on the absolute and relative risks of VTE by using several recently linked data sources from England. .6 per 1000 person-years) than that in women who did not receive chemotherapy. After surgery, the risk was significantly increased in the first month (hazard ratio [HR], 2.2; 95% CI, 1.4-3.4; AR, 23.5; reference group, no surgery), but the risk was not increased after the first month. Risk of VTE was noticeably higher in the 3 months after initiation of tamoxifen compared with the risk before therapy (HR, 5.5; 95% CI, 2.3-12.7; AR, 24.1); however, initiating therapy with aromatase inhibitors was not associated with VTE (HR, 0.8; 95% CI, 0.5-1.4; AR, 28.3). In conclusion, women receiving chemotherapy for breast cancer have a clinically important risk of VTE, whereas an increased risk of VTE immediately after endocrine therapy is restricted to tamoxifen. (Blood. 2016;127(7):849-857) Medscape Continuing Medical Education onlineThis activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint providership of Medscape, LLC and the American Society of Hematology. Medscape, LLC is accredited by the ACCME to provide continuing medical education for physicians. Medscape, LLC designates this Journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. All other clinicians completing this activity will be issued a certificate of participation. To participate in this journal CME activity: (1) review the learning objectives and author disclosures; (2) study the education content; (3) take the post-test with a 75% minimum passing score and complete the evaluation at http://www.medscape.org/journal/blood; and (4) view/print certificate. For CME questions, see page 953. Disclosures Thomas L. Ortel, Associate Editor, served as an advisor or consultant for Instrumentation Laboratory and received grants for clinical research from Instrumentation Laboratory; Eisai; Pfizer; and GlaxoSmithKline. The authors and CME questions author Laurie Barclay, freelance writer and reviewer, Medscape, LLC, declare no competing financial interests. Learning objectives1. Identify the effect of chemotherapy for breast cancer on the risk for venous thromboembolism, based on an English cohort study.2. Determi...

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Section: 2supporting

confidence: 88%

When are breast cancer patients at highest risk of venous thromboembolism? A cohort study using English health care data

Walker

West

Card

et al. 2016

Blood

103

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“…Raloxifene increases the risk of VTE similarly to what has been observed with tamoxifen and E use in postmenopausal women (4,(12)(13)(14). In the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, the risk of venous thromboembolic disease (deep venous thrombosis or pulmonary embolism) was found to be 3.1 times higher (95% confidence interval, 1.5 to 6.2) in women assigned to the raloxifene group than to the placebo group.…”

Section: Discussionmentioning

confidence: 74%

Procoagulant state after raloxifene therapy in postmenopausal women

Azevedo

Franco

Baggio

et al. 2005

Fertility and Sterility

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Objective: To investigate the effects of raloxifene on the hemostatic system in postmenopausal women. Design: A prospective longitudinal study. Setting: Outpatient clinic of the Faculty of Medicine of Ribeirão Preto, Brazil. Patient(s): Sixteen postmenopausal women aged 56.8 Ϯ 5.9 years (mean Ϯ SD). Intervention(s): Raloxifene hydrochloride (60 mg once daily) was administered orally for a period of 6 months. Main Outcome Measure(s): Plasma activities of coagulation factors (II, V, VII, VIII, IX, X, XI, XII, and fibrinogen), prothrombin-derived fragment 1ϩ2, and activated protein C (APC) sensitivity ratio were measured at baseline and after 1, 3, and 6 months of treatment. Result(s): Factor VIII activity increased by 17.1% and 26.9% at 3 and 6 months of treatment, respectively, compared with baseline. Factor XI and FXII activities significantly increased by 10.9% and 43.1%, respectively, after 6 months compared with baseline. A significant reduction of APC sensitivity ratio also was observed after 6 months of treatment. Conclusion(s):A procoagulant state characterized by increased factor VIII, XI, and XII plasma levels and by reduced APC sensitivity was observed after raloxifene therapy in post-menopausal women. (Fertil Steril 2005; 84:1680 -4. ©2005 by American Society for Reproductive Medicine.)Key Words: Climacteric, hemostatic system, raloxifene, SERMs Raloxifene is a selective estrogen receptor modulator and exerts tissue-selective effects similar to those of estrogen (E) on bone and serum lipids, without any apparent stimulatory effect on mammary and uterine tissues (1-5). The effect of raloxifene on the cardiovascular system in postmenopausal women has been studied, and the favorable results have been explained mainly by its effects on metabolic changes in lipoproteins, homocysteine, and improved endothelium-dependent vasomotricity, preventing arteriosclerosis and acting as a vasodilating agent (6 -9).Despite these benefits, raloxifene therapy increases the risk of venous thromboembolism (VTE) by approximately threefold, a similar effect to that observed with hormone therapy (HT) (4). Although a large body of data supports a procoagulant state related to E administration, there are few published data on the effect of raloxifene on hemostatic parameters in postmenopausal women. In an article published elsewhere (10), we reported that raloxifene therapy is associated with a significant reduction in plasma antithrombin activity, suggesting that this effect may contribute to a procoagulant state and partly explain the increased risk of VTE in raloxifene users. Here, we report the results of a longitudinal study assessing the effects of raloxifene on other hemostatic parameters in healthy postmenopausal women. MATERIALS AND METHODS Study SubjectsSixteen postmenopausal women were enrolled in a prospective longitudinal study. General characteristics of the subjects were as follows (values given as mean Ϯ SD): age, 56.8 Ϯ 5.9 years; duration of menopause, 9.3 Ϯ 5.5 years; and body mass index, 25.8 Ϯ 3.7 kg/m 2 . ...

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“…В исследованиях по профилактическому применению тамоксифена у здоро-вых женщин отмечено двукратное повышение относи-тельного риска венозных тромбоэмболических событий, исключая тромбофлебиты поверхностных вен (ОР 1,9, 95% ДИ 1,4-2,6, р<0,0001) [41]. Эти риски сопоставимы с таковыми при приеме оральных контрацептивов или заместительной гормональной терапии [42]. Такая же закономерность отмечена и в адъювантных исследовани-ях: в группе тамоксифена отмечалось 1,5-7,1-кратное увеличение риска венозной тромбоэмболии по сравне-нию с плацебо, хотя 40% событий регистрировались после крупных хирургических вмешательств, т. е. были ситуационными [42].…”

Section: тромбоэмболические осложненияunclassified