Long-term Rivaroxaban for the Treatment of Acute Venous Thromboembolism in Patients With Active Cancer in a Prospective Multicenter Trial

Authors
Ho-Young YhimWon-Il ChoiSung-Hyun KimSeung-Hyun NamKyoung Ha KimYeung-Chul MunDoyeun OhHun-Gyu HwangKeun-Wook LeeEun-Kee SongYong Shik KwonSoo-Mee Bang
Department
Dept. of Internal Medicine (내과학)
Issue Date
2019
Citation
Korean journal of internal medicine, Vol.34(5) : 1125-1135, 2019
ISSN
2005-6648
Abstract
Background/Aims: Limited data are available regarding the efficacy of rivaroxaban for the treatment of cancer-associated venous thromboembolism (VTE). The aim of this study was to evaluate the effectiveness and safety of rivaroxaban for the treatment of VTE in active cancer patients. Methods: In this prospective, multicenter, open-label trial (NCT01989845), we enrolled patients with active cancer and objectively diagnosed lower-extremity deep vein thrombosis, pulmonary embolism (PE), or both from November 2013 to June 2016. Active cancer was defined as a histologically confirmed malignancy, which was diagnosed or treated within the previous 6 months, or as a recurrent/metastatic cancer. Patients received oral rivaroxaban 15 mg twice daily for first 3 weeks, followed by 20 mg once daily for 6 months. The primary outcome was the symptomatic recurrent VTE and the secondary outcomes included any recurrent VTE, major or clinically relevant non-major (CRNM) bleeding events, and overall mortality. All study outcomes were validated by blinded central adjudication. Results: Of 124 patients enrolled, 110 (88.7%) had solid cancer, 93 (75.0%) had metastatic disease, and 110 (88.7%) were receiving chemotherapy or radiotherapy. During the 6-month study period, seven patients experienced symptomatic recurrent VTE (cumulative incidence, 5.9%), and two patients experienced incidental recurrent PE (cumulative incidence of any recurrent VTE, 7.6%). Major bleeding events occurred in six patients (cumulative incidence, 5.3%) and CRNM bleeding events in 11 patients (cumulative incidence, 10.2%). Twenty-eight patients (overall mortality, 24.0%) died. Conclusions: Rivaroxaban is effective and safe for the treatment of VTE in patients with active cancer.
Keywords
NeoplasmsRecurrenceRivaroxabanVenous thromboembolismTherapeutics
URI
http://kumel.medlib.dsmc.or.kr/handle/2015.oak/42382
Appears in Collections:
1. Journal Papers (연구논문) > 1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
Keimyung Author(s)
최원일; 권용식
Full Text
http://kjim.org/journal/view.php?doi=10.3904/kjim.2018.097
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