Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation

Kahale, Lara A; Hakoum, Maram B; Tsolakian, Ibrahim G; Matar, Charbel F; Barba, Maddalena; Yosuico, Victor E D; Terrenato, Irene; Sperati, Francesca; Akl, Elie A.

doi:10.1002/14651858.cd006466.pub6

Cited by 25 publications

(23 citation statements)

References 116 publications

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“…In the attempt to interpret these findings correctly, the lack of data specifically referred to the site of cancer origin should be considered. Indeed, the need of further evidence specifically related to the cancer type and stage is acknowledged by the authors themselves when discussing their research implications [ 29 ].…”

Section: Discussionmentioning

confidence: 99%

Observational study of coagulation activation in early breast cancer: development of a prognostic model based on data from the real world setting

et al. 2018

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BackgroundCancer and coagulation activation are tightly related. The extent to which factors related to both these pathologic conditions concur to patient prognosis intensely animates the inherent research areas. The study herein presented aimed to the development of a tool for the assessment and stratification of risk of death and disease recurrence in early breast cancer.MethodsBetween 2008 and 2010, two hundreds thirty-five (N: 235) patients diagnosed with stage I–IIA breast cancer were included. Data on patient demographics and clinic-pathologic features were collected in course of face-to-face interviews or actively retrieved from clinical charts. Plasma levels of plasminogen activator inhibitor type 1 (PAI-1), fragment 1 + 2 (F1 + 2), thrombin antithrombin complex (TAT), factor VIII (FVIII), and D-dimer (DD) were measured at breast cancer diagnosis and prior to any therapeutic procedure, including breast surgery. The risk of death was computed in terms of overall survival (OS), which was the primary outcome. For a subset of patients (N = 62), disease free survival (DFS) was also assessed as a measure of risk of disease recurrence.ResultsMedian follow up was 95 months (range 6–112 months). Mean age at diagnosis was 60.3 ± 13.4 years. Cancer cases were more commonly intraductal carcinomas (N: 204; 86.8%), pT1 (131; 55.7%), pN0 (141; 60%) and G2 (126; 53.6%). Elevated levels of PAI-1 (113; 48.1%) represented the most frequent coagulation abnormality, followed by higher levels of F1 + 2 (97; 41.3%), DD (63; 27.0%), TAT (34; 40%), and FVIII (29; 12.3%). In univariate models of OS, age, pT, DD, FVIII were prognostically relevant. In multivariate models of OS, age (p = 0.043), pT (p = 0.001), levels of DD (p = 0.029) and FVIII (p = 0.087) were confirmed. In the smaller subgroup of 62 patients, lymph node involvement, percent expression of estrogen receptors and levels of FVIII impacted DFS significantly.ConclusionsWe developed a risk assessment tool for OS including patient- and cancer-related features along with biomarkers of coagulation activation in a cohort of early BC patients. Further studies are warranted to validate our prognostic model in the early setting and eventually extend its application to risk evaluation in the advanced setting for breast and other cancers.Electronic supplementary materialThe online version of this article (10.1186/s12967-018-1511-x) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Observational study of coagulation activation in early breast cancer: development of a prognostic model based on data from the real world setting

et al. 2018

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“…Recent evidence analysis by Kahale et al [87] could not confirm any survival benefit from treatments with oral anticoagulant agents, VKA, or DOACs in cancer patients with no previous VTE, but they did confirm an increase of bleeding risk.…”

Section: Anticoagulation In the Absence Of Vte To Improve Survival Inmentioning

confidence: 91%

SEOM clinical guideline of venous thromboembolism (VTE) and cancer (2019)

et al. 2020

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In 2011, the Spanish Society of Medical Oncology (SEOM) first published a clinical guideline of venous thromboembolism (VTE) and cancer. This guideline was updated in 2014, and since then, multiple studies and clinical trials have changed the landscape of the treatment and prophylaxis of VTE in cancer patients. To incorporate the most recent evidence, including data from direct oral anticoagulants (DOACs) randomized clinical trials, SEOM presents a new update of the guideline.

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“…3,4 In addition, Cochrane meta-analysis reviews have shown that LMWH consistently reduces the occurrence of symptomatic VTE but likely increases major and minor bleeding in cancer patients. [5][6][7] Despite these findings, LMHW is not routinely recommended in current guideline because of the low incidence of VTE in unselected patients, potentially increased risk of bleeding, high cost, and inconvenience of injections. 8 To determine which patients would receive the most benefit from a preventive strategy, recent studies have used a risk-stratified approach to study the impact of thromboprophylaxis in higher risk VTE patients based on the Khorana score.…”

Section: Introductionmentioning

confidence: 99%

“…Several randomized controlled trials (RCTs) have demonstrated benefit for low molecular weight heparin (LMWH) thromboprophylaxis in ambulatory cancer patients . In addition, Cochrane meta‐analysis reviews have shown that LMWH consistently reduces the occurrence of symptomatic VTE but likely increases major and minor bleeding in cancer patients . Despite these findings, LMHW is not routinely recommended in current guideline because of the low incidence of VTE in unselected patients, potentially increased risk of bleeding, high cost, and inconvenience of injections …”

Section: Introductionmentioning

confidence: 99%

Direct oral anticoagulant for the prevention of thrombosis in ambulatory patients with cancer: A systematic review and meta‐analysis

Kuderer

García

et al. 2019

Journal of Thrombosis and Haemostasis

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Background It is unclear if direct oral anticoagulant (DOAC) is efficacious and safe for prophylaxis of venous thromboembolism (VTE) in ambulatory patients with cancer. Methods We performed a systematic review using EMBASE, MEDLINE, and CENTRAL. Inclusion criteria included adult ambulatory patients with cancer, prophylactic use of DOAC, and randomized controlled trials. Exclusion criteria included pediatric patients, inpatient or postoperative setting, therapeutic indication of DOAC, or non‐phase III randomized controlled trial. Two authors screened/reviewed articles and abstracted the data. Meta‐analysis was performed using random‐effects model. Efficacy outcome included overall and symptomatic VTE incidence during the first 6 months. Safety outcomes included major bleeding and clinically relevant non‐major bleeding (CRNMB) incidence during the on‐treatment period. Subgroup analysis was performed for intermediate‐ and high‐risk Khorana score. Results A total of 202 records were identified and 28 full‐text articles were assessed. Two studies with 1415 participants were included for meta‐analysis. For DOAC vs placebo, the relative risks for overall and symptomatic VTE incidence by 6 months were 0.56 (0.35‐0.89) and 0.58 (0.29‐1.13), respectively. The relative risks for major bleeding and CRNMB while on‐treatment were 1.96 (0.80‐4.82) and 1.28 (0.74‐2.20), respectively. Patients with high‐risk Khorana score (3+) derived the largest absolute risk reduction of VTE. Conclusions Low‐dose DOAC reduces the rate of overall VTE in higher risk cancer patients starting systemic chemotherapy. It may reduce the rate of symptomatic VTE but increase the likelihood of bleeding.

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Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation

Cited by 25 publications

References 116 publications

Observational study of coagulation activation in early breast cancer: development of a prognostic model based on data from the real world setting

Observational study of coagulation activation in early breast cancer: development of a prognostic model based on data from the real world setting

SEOM clinical guideline of venous thromboembolism (VTE) and cancer (2019)

Direct oral anticoagulant for the prevention of thrombosis in ambulatory patients with cancer: A systematic review and meta‐analysis

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