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Research ArticleOpen Accesscc iconby iconnc iconnd icon

An observational study of once-weekly carfilzomib in patients with multiple myeloma in Japan (Weekly-CAR study)

    Yu Abe

    Department of Hematology, Japanese Red Cross Medical Center, Tokyo, 1508935, Japan

    ,
    Shiro Kubonishi

    Department of Hematology and Oncology, Japanese Red Cross Society Himeji Hospital, Himeji, Hyogo, 6708540, Japan

    ,
    Masaki Ri

    Department of Hematology and Oncology, Nagoya City University Institute of Medical and Pharmaceutical Sciences, Nagoya, Aichi, 4678602, Japan

    ,
    Masaki Iino

    Department of Medical Oncology, Yamanashi Prefectural Central Hospital, Kofu, Yamanashi, 4008506, Japan

    ,
    Kazutaka Sunami

    Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, 7011192, Japan

    ,
    Tomoki Ito

    Division of Hematology, First Department of Internal Medicine, Kansai Medical University Medical Center, Moriguchi, Osaka, 5708507, Japan

    ,
    Masafumi Fukaya

    Division of Hematology and Stem Cell Transplantation, Shizuoka Cancer Center, Shizuoka, 4118777, Japan

    ,
    Toshiyuki Kitano

    Department of Hematology, Medical Research Institute Kitano Hospital, Osaka, 5308480, Japan

    ,
    Sho Ikeda

    Department of Hematology, Nephrology and Rheumatology, Akita University Graduate School of Medicine, Akita, 0108543, Japan

    ,
    Shuichi Ota

    Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Hokkaido, 0030006, Japan

    ,
    Taiga Kuroi

    Department of Hematology, Chugoku Central Hospital, Fukuyama, Hiroshima, 7200001, Japan

    ,
    Noriyoshi Iriyama

    Division of Hematology and Rheumatology, Department of Medicine, Nihon University School of Medicine, Tokyo, 1738610, Japan

    ,
    Tatsuro Jo

    Department of Hematology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, 8528511, Japan

    ,
    Masaaki Adachi

    Department of Hematology, JCHO Sapporo Hokushin Hospital, Sapporo, Hokkaido, 0048618, Japan

    ,
    Daigo Akahane

    Department of Hematology, Tokyo Medical University Hospital, Tokyo, 1600023, Japan

    ,
    Tatsuyuki Kai

    Division of Hematology, Kita-Fukushima Medical Center, Fukushima, 9600502, Japan

    ,
    Yoichi Kohara

    Department of Hematology, Showa Inan General Hospital, Nagano, 3994117, Japan

    ,
    Norimitsu Kadowaki

    Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine, Faculty of Medicine, Kagawa University, Kagawa, 7610793, Japan

    &
    Teruaki Katayama

    *Author for correspondence: Tel.: +81 662 635 670;

    E-mail Address: t.katayama@ono-pharma.com

    Oncology Medical Affairs, Ono Pharmaceutical Co., Ltd, Osaka, 5418564, Japan

    Published Online:https://doi.org/10.2217/fon-2023-0834

    Background: The ARROW study demonstrated that once-weekly carfilzomib and dexamethasone (wKd) therapy significantly prolonged progression-free survival compared with twice-weekly carfilzomib and dexamethasone therapy in relapsed or refractory multiple myeloma patients. Aim: To describe the treatment patterns, effectiveness and safety of wKd therapy in real-world settings in Japan. Methods: We investigated data from the medical records of 126 Japanese patients with relapsed or refractory multiple myeloma. Results: The overall response rate was 66.3%. The median progression-free survival was 9.5 months. The incidence of treatment-emergent adverse events of any grade and grade ≥3 were 45.8 and 20.8%, respectively. Conclusion: There were no new or unexpected safety signals in this study. This study demonstrated the effectiveness and safety profiles of wKd therapy in Japan.

    Plain language summary

    Carfilzomib became available for daily clinical practice as a drug for cancer of bone marrow (multiple myeloma) that comes back or does not respond to previous drug (relapsed or refractory). This drug was approved in the USA in 2012, and in Japan in 2016. In this study, we looked at how once-weekly carfilzomib works and how safe it is in real-life situations in Japan. We screened 126 patients with relapsed or refractory multiple myeloma in Japan. The median age of the patients was 70 years, with 25% being over 75 years. This study also included some patients who were not in the best overall health, had a history of many treatments or had heart complications. In 66.3% of patients, the cancer had disappeared or the extent of the cancer had reduced after treatment. Side effects and serious side effects occurred in 45.8 and 14.2% of patients, respectively. The most common side effects were low levels of blood platelets (9.2%), high blood pressure (5.8%), loose or watery stools (5.0%), fever (5.0%), and low levels of red blood cells (4.2%). Heart disorders occurred in five patients. But all patients recovered or improved with treatment such as blood pressure lowering drugs and diuretics. These results showed that once-weekly carfilzomib works well and is safe in real-world settings in Japan. This information can help us think about how to pick the right patients and handle heart disease risks when using carfilzomib treatment.

    Papers of special note have been highlighted as: • of interest; •• of considerable interest

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