Korean J Intern Med.  2019 Sep;34(5):1125-1135. 10.3904/kjim.2018.097.

Long-term rivaroxaban for the treatment of acute venous thromboembolism in patients with active cancer in a prospective multicenter trial

Affiliations
  • 1Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea.
  • 2Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Korea.
  • 3Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Korea.
  • 4Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
  • 5Department of Internal Medicine, Veterans Health Service Medical Center, Seoul, Korea.
  • 6Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea.
  • 7Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
  • 8Department of Internal Medicine, CHA University School of Medicine, Seongnam, Korea.
  • 9Department of Internal Medicine, Soonchunhyang University Gumi Hospital, Gumi, Korea.
  • 10Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. smbang7@snu.ac.kr

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.

Keyword

Neoplasms; Recurrence; Rivaroxaban; Venous thromboembolism; Therapeutics

MeSH Terms

Drug Therapy
Hemorrhage
Humans
Incidence
Mortality
Multicenter Studies as Topic*
Prospective Studies*
Pulmonary Embolism
Radiotherapy
Recurrence
Rivaroxaban*
Venous Thromboembolism*
Venous Thrombosis
Rivaroxaban
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