Abstract 499P
Background
Initial administration of heparin is recommended when using edoxaban, a direct oral anticoagulant that has been shown to be non-inferior to low molecular weight heparin in the treatment of cancer-associated thrombosis (CAT), but it is often not practiced in actual clinical practice due to its complexity. The aim of this study was to assess the safety and efficacy of edoxaban alone treatment without initial heparin usage for asymptomatic CAT in patients with gastrointestinal cancer (GIC) who are reported to be at high risk of bleeding.
Methods
In this multicenter prospective feasibility study in 10 Japanese institutions, patients with active GIC who developed accidental asymptomatic CAT during chemotherapy were recruited. The key eligibility criteria are as follows: 1) Histologically confirmed adenocarcinoma in colorectal or non-colorectal cancers, including esophageal, gastric, pancreatic, and biliary cancer; 2) newly diagnosed, incidental, asymptomatic deep-vein thrombosis involving the popliteal, femoral, or iliac veins or asymptomatic pulmonary embolism during GIC chemotherapy; 3) age 20 to 90 years; 4) written informed consent. The edoxaban is orally administered as a once-daily dosing within three days of the detection of asymptomatic CAT. The primary outcome was the incidence of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) during the first 3 months of edoxaban administration.
Results
A total of 54 patients were finally enrolled from October 2017 to September 2020. One was excluded due to a misdiagnosis of CAT. In the evaluation of 53 patients, the primary-outcome event occurred in 6 (6/53, 11.3%). MB occurred in 4 patients (4/53, 7.5%), 3 with gastrointestinal bleeding and 1 with intracranial hemorrhage. CRNMB occurred in two patients (2/53, 3.8%), one with bleeding from the stoma site and the other with genital bleeding. There were no deaths due to bleeding, and all recovered.
Conclusions
The risk of bleeding from edoxaban administration without heparin lead for asymptomatic CAT in GIC was not significantly different from the previously reported data with heparin lead.
Clinical trial identification
jRCTs011180030, released on 25th March 2019.
Editorial acknowledgement
Legal entity responsible for the study
Hokkaido Gastrointestinal Cancer Study Group.
Funding
Daiichi Sankyo.
Disclosure
M. Nakamura: Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Eli Lilly Japan K.K.; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Invited Speaker: Taiho; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Bristol-Myers Squibb. A. Hosokawa: Financial Interests, Personal, Speaker’s Bureau: Daiichi Sankyo. N. Izawa: Financial Interests, Personal, Speaker’s Bureau: Daiichi Sankyo. Y. Sunakawa: Financial Interests, Personal, Speaker’s Bureau: Daiichi Sankyo. Y. Komatsu: Financial Interests, Personal, Sponsor/Funding: Daiichi Sankyo. All other authors have declared no conflicts of interest.