Death was also a competing end point. least 7?days was 5.5% (95% CI, ?3.7%\7.1%), and 73.3% of major bleeds occurred in the GI tract. The 6\month cumulative mortality rate was 22.2% (95% CI,?19.4%\24.9%). The elderly had similar rates of recurrent thrombosis and bleeding as those aged under 75?years. Conclusion Our institutional experience suggests that in appropriately selected patients, rivaroxaban may be used Dasatinib (BMS-354825) for treatment of CAT Dasatinib (BMS-354825) with promising safety and efficacy. strong class=”kwd-title” Keywords: aged, hemorrhage, neoplasms, rivaroxaban, venous thromboembolism Essentials Rivaroxaban is effective treatment of cancer\associated thrombosis (CAT) but with increased bleeding. We describe results of an institutional protocol for CAT treatment with rivaroxaban. We recommended avoiding rivaroxaban in patients with gastrointestinal or genitourinary tract lesions, and dose reduction for age??75. Results showed acceptable efficacy and safety. 1.?INTRODUCTION Venous thromboembolism (VTE) is major source of morbidity and mortality in cancer patients.1, 2 Incidence rates of cancer\associated thrombosis (CAT) vary with cancer type, stage, treatment, and comorbidities, but it is estimated that approximately 15% to 20% of cancer patients will develop a venous thromboembolic episode at some point during the course of their illness.3, 4 Treatment of CAT is particularly challenging, with higher rates of recurrence and major bleeding than for nonCcancer patients with VTE.5 Low\molecular\weight heparins (LMWHs) have been shown to be superior to vitamin K antagonists such as warfarin,6 although LMWHs are expensive and the injections are burdensome to patients, leading to poor compliance.7 Across several studies of an LMWH to treat CAT, the rates of VTE recurrence and major bleeding with LWMH are approximately 7% to 8% and 4% to 5%, respectively.6, 7, 8 There is a growing body of data supporting the effective use of direct oral anticoagulants (DOACs) for treatment of CAT. Rivaroxaban was the first DOAC approved by the US Food and Drug Administration (FDA) for treatment of VTE, in 2012. The approval did not address the specific niche of cancer, either supporting use or cautioning against use, as the 2 2 pivotal phase III trials leading to approval included approximately 5.6% of cancer patients in the rivaroxaban\treated arms.9, 10 A subsequent subgroup analysis of the EINSTEIN trials of cancer patients did not indicate any signal of particular risk in the cancer patients.11 In 2013, we designed a Clinical Pathway to guide use of rivaroxaban in Dasatinib (BMS-354825) cancer patients within Memorial Sloan Kettering Cancer uvomorulin Center. The Dasatinib (BMS-354825) key criteria were to recommend against use of rivaroxaban in patients with active luminal gastrointestinal (GI) tract or genitourinary (GU) tract lesions. In addition, we employed a modest dose reduction in the elderly. In 2017, we published outcomes of our first 200\patient cohort of patients with CAT treated with rivaroxaban, following our Clinical Pathway, and demonstrated both low rates of recurrent VTE (4.4%; 95% confidence interval [CI],?1.4%\7.4%) and major bleeding (2.2%; 95% CI,?0%\4.2%) at 6?months. 12 Since our first report of our single institutional experience, 2 randomized clinical trials (RCTs) comparing a DOAC with an LMWH have been published, the HOKUSAI VTE Cancer trial of edoxaban13 and the SELECT\D trial of rivaroxaban.14 Both studies demonstrated a trend toward lower rates of recurrent VTE with the DOAC but with higher rates of bleeding, particularly in the GI and GU tracts.13, 14 We now report on efficacy and safety outcomes in an expanded cohort of 1072 patients with CAT, who received rivaroxaban for treatment. To our knowledge, this is the largest reported population of cancer patients treated with a DOAC. 2.?MATERIALS AND METHODS 2.1. Clinical pathway The Clinical Pathway was designed to help guide clinician use of rivaroxaban for CAT within our institution (Appendix S1). Key points of the Clinical Pathway include patient selection. Active luminal lesions of the GI or GU tract were considered contraindications. Bioavailability of rivaroxaban is approximately? ?80%,15 but active drug remains in the upper GI lumen. Similarly, rivaroxaban and other DOACs are excreted in the urine at biologically active concentrations. 16 In the presence of known luminal lesions of the GI or GU tract, an LMWH was recommended instead. Untreated central nervous system neoplasms were also a considered a contraindication to the use of rivaroxaban, as at the time there were no published data on safety.