Apixaban in Japanese patients with cancer-associated venous thromboembolism: a multi-center phase II trial

Background Recent pivotal phase III trials involving direct oral anticoagulant (DOAC) versus low molecular weight heparin have demonstrated the utility of DOACs in Western patients with cancer-associated venous thromboembolism (VTE). However, these trials did not include Japanese patients. This phas...

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Bibliographic Details
Published in:International journal of hematology 2022-04, Vol.115 (4), p.499-507
Main Authors: Imamura, Yoshinori, Otsui, Kazunori, Mori, Kenta, Kitagawa, Koichi, Okada, Hideaki, Hata, Akito, Hayashi, Hidetoshi, Nose, Taku, Ohata, Shinya, Miyata, Yoshiharu, Funakoshi, Yohei, Toyoda, Masanori, Yakushijin, Kimikazu, Kiyota, Naomi, Matsuoka, Hiroshi, Minami, Hironobu
Format: Article
Language:English
Subjects:
Administration, Oral
Aged
Anticoagulants
Bleeding
Body weight
Cancer
Clinical trials
Confidence intervals
Gastrointestinal system
Gastrointestinal tract
Hematology
Heparin
Humans
Japan - epidemiology
Low molecular weights
Medicine
Medicine & Public Health
Molecular weight
Neoplasms - complications
Neoplasms - drug therapy
Oncology
Original Article
Patients
Pyrazoles
Pyridones - adverse effects
Safety
Thromboembolism
Tumors
Venous Thromboembolism - drug therapy
Venous Thromboembolism - epidemiology
Venous Thromboembolism - etiology
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Summary:Background Recent pivotal phase III trials involving direct oral anticoagulant (DOAC) versus low molecular weight heparin have demonstrated the utility of DOACs in Western patients with cancer-associated venous thromboembolism (VTE). However, these trials did not include Japanese patients. This phase II trial evaluated the safety and efficacy of apixaban in Japanese patients with cancer-associated VTE (UMIN000028447). Method and results Apixaban was initiated at 10 mg twice daily for 7 days, followed by 5 mg twice daily for 23 weeks. The primary endpoint was the incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period. The study was terminated due to safety concerns after enrolling 27 patients. Median age was 71 years; median body weight was 51.3 kg; and major primary tumor sites were the gastrointestinal tract (26%) and lung (19%). During the median follow-up period of 5.4 months, major or CRNM bleeding occurred in in 26% of patients (major, n  = 5; CRNM, n  = 2; 95% confidence interval, 11–46%). No recurrent VTE or VTE-related death occurred. Estimated overall survival at 6 months was 68%. Conclusion This study demonstrated the excessive bleeding risk of apixaban at the standard dose in Japanese patients with cancer-associated VTE.
ISSN:0925-5710
1865-3774
DOI:10.1007/s12185-022-03289-w