Long-term rivaroxaban for the treatment of acute venous thromboembolism in patients with active cancer in a prospective multicenter trialopen access
- Authors
- Yhim, Ho-Young; Choi, Won-Il; Kim, Sung-Hyun; Nam, Seung-Hyun; Kim, Kyoung Ha; Mun, Yeung-Chul; Oh, Doyeun; Hwang, Hun-Gyu; Lee, Keun-Wook; Song, Eun-Kee; Kwon, Yong Shik; Bang, Soo-Mee
- Issue Date
- Sep-2019
- Publisher
- 대한내과학회
- Keywords
- Neoplasms; Recurrence; Rivaroxaban; Venous thromboembolism; Therapeutics
- Citation
- The Korean Journal of Internal Medicine, v.34, no.5, pp 1125 - 1135
- Pages
- 11
- Journal Title
- The Korean Journal of Internal Medicine
- Volume
- 34
- Number
- 5
- Start Page
- 1125
- End Page
- 1135
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/4273
- DOI
- 10.3904/kjim.2018.097
- ISSN
- 1226-3303
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 no (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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Collections - College of Medicine > Department of Internal Medicine > 1. Journal Articles
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