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KMID : 0338420190340051125
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Korean Journal of Internal Medicine
2019 Volume.34 No. 5 p.1125 ~ p.1135
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Long-term rivaroxaban for the treatment of acute venous thromboembolism in patients with active cancer in a prospective multicenter trial
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Yhim Ho-Young
Choi Won-Il
Kim Sung-Hyun
Nam Seung-Hyun
Kim Kyoung-Ha
Mun Yeung-Chul
Oh Do-Yeun
Hwang Hun-Gyu
Lee Keun-Wook
Song Eun-Kee
Kwon Yong-Shik
Bang Soo-Mee
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Abstract
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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.
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KEYWORD
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Neoplasms, Recurrence, Rivaroxaban, Venous thromboembolism, Therapeutics
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