A feasibility study of edoxaban for the cancer-associated asymptomatic venous thromboembolism in Japanese gastrointestinal cancer patients receivin...

Date 24 November 2018
Event ESMO Asia 2018 Congress
Session Poster display - Cocktail
Topics Supportive Measures
Gastrointestinal Cancers
Presenter Michio Nakamura
Citation Annals of Oncology (2018) 29 (suppl_9): ix129-ix138. 10.1093/annonc/mdy444
Authors M. Nakamura1, M. Yagisawa2, T. Saiki3, A. Ishiguro3, K. Sawada4, S. Yuki5, T. Sasaki6, T. Ando7, H. Ohori8, M. Kotaka9, O. Muto10, Y. Shindo11, K. Nakashima12, A. Hosokawa12, A. Doi13, N. Izawa13, Y. Sunakawa13, A. Satoh14, K. Ono15, Y. Komatsu4
  • 1Gastroenterology, Sapporo City General Hospital, 060-8604 - Sapporo/JP
  • 2Gastroenterology, National Cancer Center East, Kashiwa/JP
  • 3Medical Oncology, Teine Keijinkai Hospital, 006-8555 - Sapporo/JP
  • 4Cancer Center, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 5Gastroenterology And Hepatology, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 6Gastroenterology, Hokkaido Gastroenterology Hosipital, Sapporo/JP
  • 7Gastroenterology And Hematology, Toyama University Hospital, 930-0194 - Toyama/JP
  • 8Medical Oncology, Japan Red Cross Ishinomaki Hosipital, 986-8522 - Ishinomaki/JP
  • 9Surgery, Sano Hospital-Gastrointestinal Cancer Centre, 655-0031 - Kobe/JP
  • 10Medical Oncology, Japan Red Cross Akita Hospital, 101495 - Akita/JP
  • 11Gastroenterological Surgery, Nakadori General Hospital, 010-8577 - Akita/JP
  • 12Department Of Medical Oncology, Faculty Of Medicine, University of Miyazaki, 889-1692 - Miyazaki/JP
  • 13Medical Oncology, St.Marianna University School of Medicine, 216-8511 - Kanagawa/JP
  • 14Medical Oncology, Hirosaki University Hospital, 036-8562 - Hirosaki/JP
  • 15Clinical Research And Medical Innovation Center, Hokkaido University Hospital, Sapporo/JP

Abstract

Background

Whether should asymptomatic venous thromboembolism (VTE) occurred during cancer chemotherapy be treated and the oral factor Xa inhibitor edoxaban can be useful as safely and effectively treatment in this clinical situation are unclear.

Trial design

This is a multicenter prospective feasibility study of edoxaban for the cancer-associated asymptomatic VTE in Japanese gastrointestinal cancer (GIC) patients receiving chemotherapy. The key eligibility criteria are as follows: 1) Histologically confirmed GIC.; 2) Newly diagnosed, incidental, asymptomatic deep-vein thrombosis involving the popliteal, femoral, or iliac veins or asymptomatic pulmonary embolism during GIC chemotherapy.; 3) Patients 20 years of age or older and 90 years or younger are eligible at the time of informed consent.; 4) Written informed consent to participate as a subject in this clinical study. The key exclusion criteria are as follows: 1) Symptomatic VTE at the time of diagnosed.; 2) continued to receive treatment for more than 72 hours with heparin, low-molecular-weight heparin, a vitamin K antagonist, aspirin, and/or dual antiplatelet therapy.; 3) Previous or current treatment with warfarin or edoxaban. Edoxaban is orally administered as a once-daily dosing within three days after enrollment. The starting dose is 60mg and for patients with one or more factors that increase the risk of bleeding, such as renal impairment, body weight under 60 kg, concomitant use of P-gp inhibitors, the dose is reduced by half. The primary endpoint is to investigate the incidence of major bleeding and clinically relevant non-major bleeding during 3 months after enrollment. Key secondary endpoints are to evaluate the diminution rate of VTE, time to diminution of VTE, total amounts of edoxaban, and the incidence of newly symptomatic/asymptomatic VTE. This study is supported by Daiichi-Sankyo and sponsored by Hokkaido Gastrointestinal Cancer Study Group and registered as UMIN000028517.

Editorial acknowledgement

Clinical trial identification

UMIN000028517.

Legal entity responsible for the study

Hokkaido Gastrointestinal Chemotherapy Study Group (HGCSG).

Funding

Daiichi Sankyo.

Disclosure

M. Nakamura: Honoraria: AstraZeneca, Bayer Yakuhin, Chugai, Daiichi Sankyo, Merck Serono, Nippon Boehringer Ingelheim, Taiho, Takeda. T. Sasaki: Honoraria: Lilly. Y. Komatsu: Honoraria: Taiho, Yakult Honsha, Merck Serono, Daiichi Sankyo. Research fund: Taiho, Yakult Honsha, Daiichi Sankyo, Merck Serono, Lilly. All other authors have declared no conflicts of interest.