PB1443 - Prospective multicenter observational study evaluating the efficacy and safety of edoxaban in Korean patients with cancer-associated venous thromboembolism (VTE)

Tuesday, June 25, 2024

13:45 – 14:45 ICT

Room: Exhibition Hall

Presenting Author(s)

HY

Ho-Young Yhim, MD, PhD

Clinician-Scientist
Jeonbuk National University Medical School
Jeonju, Cholla-bukto, Republic of Korea

Co-Author(s)

SK

Sung-Hyun Kim

MD, PhD
Dong-A University College of Medicine
Busan, Pusan-jikhalsi, Republic of Korea
DY

Deok-Hwan Yang

MD, PhD
Chonnam National University Medical School, Chonnam National University Hwasun Hospital
Jeollanam-do, Cholla-namdo, Republic of Korea
YM

Yeung-Chul Mun

MD, PhD
Ewha Womans University School of Medicine
Seoul, Seoul-t'ukpyolsi, Republic of Korea
KK

Kyoung Ha Kim

MD, PhD
Soonchunhyang University College of Medicine
Seoul, Seoul-t'ukpyolsi, Republic of Korea
WL

Won Sik Lee

MD, PhD
Inje University Busan Paik Hospital
Busan, Pusan-jikhalsi, Republic of Korea
GL

Gyeong-Won Lee

MD, PhD
Gyeongsang National University Hospital, Gyeongsang National University College of Medicine
Jinju, Kyongsang-namdo, Republic of Korea
YL

Yoo Jin Lee

MD, PhD
Ulsan University Hospital, University of Ulsan College of Medicine
Ulsan, Kyongsang-bukto, Republic of Korea
Soo-Mee Bang, MD, PhD

Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam, Kyonggi-do, Republic of Korea
EL

Eunyoung Lee

MD, PhD
National Cancer Center
Goyang, Kyonggi-do, Republic of Korea
YC

Younak Choi

MD, PhD
Pusan National University Yangsan Hospital, Pusan National University School of Medicine
Yangsan, Kyongsang-namdo, Republic of Korea
YD

Young Rok Do

MD, PhD
Dongsan Medical Center, Keimyung University
Daegu, Taegu-jikhalsi, Republic of Korea
JK

Jin Seok Kim

MD, PhD
Severance Hospital, Yonsei University College of Medicine
Seoul, Seoul-t'ukpyolsi, Republic of Korea

Background: Limited data exists reflecting the specific characteristics of East Asians (lower body weight and creatinine clearance) in edoxaban treatment for cancer-associated VTE.

Aims: To evaluate the efficacy and safety of edoxaban in Korean patients with cancer-associated VTE.

Methods: This ongoing prospective study enrolled active cancer patients newly diagnosed with proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) since January 2020. After ≥5 days of low-molecular-weight-heparin, patients received oral edoxaban (60 mg once daily) for 6 to 12 months. Patients with creatinine clearance of 30-50 mL/min or body weight of ≤60 kg.received a lower dose (30 mg once daily). Primary outcome, a composite of recurrent VTE or major bleeding for 12 months, was calculated with cumulative incidence method, considering death as a competing risk (registered at http://cris.nih.go.kr, KCT0004697).

Results: Between January 2020 and April 2023, 94 patients (mean age 67, 64% male) were enrolled, including 46% with body weight ≤60 kg and 23% with creatinine clearance 30-50 mL/min. Hematologic malignancies, including lymphoma (23%) and myeloma (17%) constituted 44% of primary tumors. Qualifying VTEs were symptomatic in 67 (71%) and PE  DVT in 63%.
During the 12-month period, 7 patients experienced the primary outcome (symptomatic recurrent DVT, 1; major bleeding, 6), resulting in cumulative rate of 8.3% (95% CI, 3.6-15.6; Figure). All major bleeding occurred in the gastrointestinal (GI) tract (tumor bleeding, 3; small bowel bleeding, 2; upper GI bleeding, 1). Clinically relevant non-major bleeding occurred in 8 patients, yielding a cumulative rate of 9.8% (95% CI, 4.5-17.5), with the genitourinary tract as the most common site (N=4). Cumulative mortality was 42.0% (95% CI, 31.5-52.2).

Conclusion(s): This study, featuring a considerable number of patients with hematologic malignancies in a Korean population characterized by low body weight and creatinine clearance, demonstrates the effectiveness of edoxaban in cancer-associated VTE treatment.