Feasibility of edoxaban for asymptomatic cancer-associated thrombosis in Japanese patients with gastrointestinal cancer: ExCAVE study
Abstract Background Although initial therapy with a parenteral anticoagulant is required before edoxaban, this strategy is frequently avoided in actual clinical practice because of its complexity. This study assessed the feasibility of edoxaban without initial heparin usage for asymptomatic cancer-a...
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BMC
2022-12-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-022-10403-y |
| _version_ | 1811196644769660928 |
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| author | Michio Nakamura Atsushi Ishiguro Masayoshi Dazai Yasuyuki Kawamoto Satoshi Yuki Susumu Sogabe Ayumu Hosokawa Kentaro Sawada Osamu Muto Naoki Izawa Koji Nakashima Yoshiki Horie Masataka Yagisawa Shinya Kajiura Takayuki Ando Yosuke Mitsuhashi Yu Sunakawa Yasuka Kikuchi Yoshito Komatsu |
| author_facet | Michio Nakamura Atsushi Ishiguro Masayoshi Dazai Yasuyuki Kawamoto Satoshi Yuki Susumu Sogabe Ayumu Hosokawa Kentaro Sawada Osamu Muto Naoki Izawa Koji Nakashima Yoshiki Horie Masataka Yagisawa Shinya Kajiura Takayuki Ando Yosuke Mitsuhashi Yu Sunakawa Yasuka Kikuchi Yoshito Komatsu |
| author_sort | Michio Nakamura |
| collection | DOAJ |
| description | Abstract Background Although initial therapy with a parenteral anticoagulant is required before edoxaban, this strategy is frequently avoided in actual clinical practice because of its complexity. This study assessed the feasibility of edoxaban without initial heparin usage for asymptomatic cancer-associated thrombosis (CAT) in Japanese patients with gastrointestinal cancer (GIC) at high risk of bleeding. Methods In this multicenter prospective feasibility study conducted at 10 Japanese institutions, patients with active GIC who developed accidental asymptomatic CAT during chemotherapy were recruited. Edoxaban was orally administered once daily without initial parenteral anticoagulant therapy within 3 days after detecting asymptomatic CAT. The primary outcome was the incidence of major bleeding (MB) or clinically relevant non-major bleeding (CRNMB) during the first 3 months of edoxaban administration. Results Of the 54 patients enrolled from October 2017 to September 2020, one was excluded because of a misdiagnosis of CAT. In the remaining 53 patients, the primary outcome occurred in six patients (11.3%). MB occurred in four patients (7.5%), including gastrointestinal bleeding in three patients and intracranial hemorrhage in one patient. CRNMB occurred in two patients (3.8%), including bleeding from the stoma site and genital bleeding in one patient each. There were no deaths attributable to bleeding, and all patients who experienced MB or CRNMB recovered. Conclusions The risk of bleeding after edoxaban without heparin pretreatment was acceptable, demonstrating new treatment options for asymptomatic CAT in patients with GIC. |
| first_indexed | 2024-04-12T01:02:26Z |
| format | Article |
| id | doaj.art-920bd0892d904f39b7d402794cf1198e |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-12T01:02:26Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-920bd0892d904f39b7d402794cf1198e2022-12-22T03:54:24ZengBMCBMC Cancer1471-24072022-12-0122111110.1186/s12885-022-10403-yFeasibility of edoxaban for asymptomatic cancer-associated thrombosis in Japanese patients with gastrointestinal cancer: ExCAVE studyMichio Nakamura0Atsushi Ishiguro1Masayoshi Dazai2Yasuyuki Kawamoto3Satoshi Yuki4Susumu Sogabe5Ayumu Hosokawa6Kentaro Sawada7Osamu Muto8Naoki Izawa9Koji Nakashima10Yoshiki Horie11Masataka Yagisawa12Shinya Kajiura13Takayuki Ando14Yosuke Mitsuhashi15Yu Sunakawa16Yasuka Kikuchi17Yoshito Komatsu18Department of Gastroenterology, Sapporo City General HospitalDepartment of Medical Oncology, Teine Keijinkai HospitalDepartment of Gastroenterology, Sapporo Medical Center NTT ECDivision of Cancer Center, Hokkaido University HospitalDepartment of Gastroenterology and Hepatology, Hokkaido University HospitalDepartment of Medical Oncology, KKR Sapporo Medical CenterDepartment of Clinical Oncology, University of Miyazaki HospitalDepartment of Medical Oncology, Kushiro Rosai HospitalDepartment of Medical Oncology, Japanese Red Cross Akita HospitalDepartment of Clinical Oncology, St. Marianna University School of MedicineDepartment of Clinical Oncology, University of Miyazaki HospitalDepartment of Clinical Oncology, St. Marianna University School of MedicineDepartment of Gastroenterology, Japanese Red Cross Kitami HospitalDepartment of Medical Oncology, Toyama University HospitalThird Department of Internal Medicine, University of ToyamaDepartment of Surgery, IMS Sapporo Digestive Disease Center General HospitalDepartment of Clinical Oncology, St. Marianna University School of MedicineDepartment of Diagnostic Imaging, Faculty of Medicine, Hokkaido UniversityDivision of Cancer Center, Hokkaido University HospitalAbstract Background Although initial therapy with a parenteral anticoagulant is required before edoxaban, this strategy is frequently avoided in actual clinical practice because of its complexity. This study assessed the feasibility of edoxaban without initial heparin usage for asymptomatic cancer-associated thrombosis (CAT) in Japanese patients with gastrointestinal cancer (GIC) at high risk of bleeding. Methods In this multicenter prospective feasibility study conducted at 10 Japanese institutions, patients with active GIC who developed accidental asymptomatic CAT during chemotherapy were recruited. Edoxaban was orally administered once daily without initial parenteral anticoagulant therapy within 3 days after detecting asymptomatic CAT. The primary outcome was the incidence of major bleeding (MB) or clinically relevant non-major bleeding (CRNMB) during the first 3 months of edoxaban administration. Results Of the 54 patients enrolled from October 2017 to September 2020, one was excluded because of a misdiagnosis of CAT. In the remaining 53 patients, the primary outcome occurred in six patients (11.3%). MB occurred in four patients (7.5%), including gastrointestinal bleeding in three patients and intracranial hemorrhage in one patient. CRNMB occurred in two patients (3.8%), including bleeding from the stoma site and genital bleeding in one patient each. There were no deaths attributable to bleeding, and all patients who experienced MB or CRNMB recovered. Conclusions The risk of bleeding after edoxaban without heparin pretreatment was acceptable, demonstrating new treatment options for asymptomatic CAT in patients with GIC.https://doi.org/10.1186/s12885-022-10403-yThrombosisEdoxabanGastrointestinal cancerBleedingHeparin |
| spellingShingle | Michio Nakamura Atsushi Ishiguro Masayoshi Dazai Yasuyuki Kawamoto Satoshi Yuki Susumu Sogabe Ayumu Hosokawa Kentaro Sawada Osamu Muto Naoki Izawa Koji Nakashima Yoshiki Horie Masataka Yagisawa Shinya Kajiura Takayuki Ando Yosuke Mitsuhashi Yu Sunakawa Yasuka Kikuchi Yoshito Komatsu Feasibility of edoxaban for asymptomatic cancer-associated thrombosis in Japanese patients with gastrointestinal cancer: ExCAVE study BMC Cancer Thrombosis Edoxaban Gastrointestinal cancer Bleeding Heparin |
| title | Feasibility of edoxaban for asymptomatic cancer-associated thrombosis in Japanese patients with gastrointestinal cancer: ExCAVE study |
| title_full | Feasibility of edoxaban for asymptomatic cancer-associated thrombosis in Japanese patients with gastrointestinal cancer: ExCAVE study |
| title_fullStr | Feasibility of edoxaban for asymptomatic cancer-associated thrombosis in Japanese patients with gastrointestinal cancer: ExCAVE study |
| title_full_unstemmed | Feasibility of edoxaban for asymptomatic cancer-associated thrombosis in Japanese patients with gastrointestinal cancer: ExCAVE study |
| title_short | Feasibility of edoxaban for asymptomatic cancer-associated thrombosis in Japanese patients with gastrointestinal cancer: ExCAVE study |
| title_sort | feasibility of edoxaban for asymptomatic cancer associated thrombosis in japanese patients with gastrointestinal cancer excave study |
| topic | Thrombosis Edoxaban Gastrointestinal cancer Bleeding Heparin |
| url | https://doi.org/10.1186/s12885-022-10403-y |
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