caa a22 4500 605491321 CHVBK 20210128100509.0 cr unu---uuuuu 210128e20150801xx s 000 0 eng 10.1007/s10147-014-0768-1 doi (NATIONALLICENCE)springer-10.1007/s10147-014-0768-1 Recombinant human soluble thrombomodulin (thrombomodulin alfa) to treat disseminated intravascular coagulation in solid tumors: results of a one-arm prospective trial [Elektronische Daten] [Kazuo Tamura, Hidehiko Saito, Hidesaku Asakura, Kohji Okamoto, Jun Tagawa, Toru Hayakawa, Nobuo Aoki] Abstract : Background: Disseminated intravascular coagulation (DIC) associated with solid tumors (DIC-ST) is often encountered in clinical practice. Patients with DIC-ST are usually in poor condition and have bleeding diathesis due to advanced or metastatic diseases. Although some affected patients are treated with heparin, this strategy has not been prospectively studied. Recombinant human soluble thrombomodulin (thrombomodulin alfa, TM-α) is a new anticoagulant developed in Japan. We conducted a prospective study that evaluated the efficacy and safety of TM-α in patients with DIC-ST. Methods: A prospective one-arm study with TM-α was conducted for DIC-ST. TM-α (380U/kg) was given for 30min intravenously once daily for 6-14days. The primary efficacy endpoint was the DIC resolution rate. Change in DIC scores and improvement in bleeding symptoms and outcomes were also evaluated. Safety endpoints included the incidence of bleeding-related adverse events. Results: A total of 101 patients were treated with TM-α. The three main underlying malignant diseases were lung, stomach, and breast cancer, which accounted for 60% of all patients. The DIC resolution rate was 34.0% at the end of TM-α treatment. Improvement in DIC scores was seen in 55.2% of patients, while only 22.9% of patients had worsening of DIC scores. The overall survival rate was 55.4% on day 28. The incidence of hemorrhage related to TM-α was 12.9% until day 28. Cases of severe hemorrhage related to TM-α did not occur. Conclusions: TM-α is effective and safe for DIC-ST. This agent is the treatment of choice for the management of DIC-ST. Japan Society of Clinical Oncology, 2014 Disseminated intravascular coagulation nationallicence Solid tumors nationallicence Anticoagulants nationallicence Thrombomodulin nationallicence Clinical trial nationallicence Tamura Kazuo Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicine, Fukuoka University Hospital, Nanakuma, Jonan-ku, 7-45-1, 814-0180, Fukuoka, Fukuoka, Japan aut Saito Hidehiko National Hospital Organization Nagoya Medical Center, Sannomaru, Naka-ku, 4-1-1, 460-0001, Nagoya, Aichi, Japan aut Asakura Hidesaku Third Department of Internal Medicine, Kanazawa University Graduate School of Medical Science, Takaramachi, 13-1, 920-8641, Kanazawa, Ishikawa, Japan aut Okamoto Kohji Center for Gastroenterology and Liver Disease, Kitakyushu Municipal Yahata Hospital, Nishihonmachi,Yahatahigashi-ku, 4-18-1, 805-0061, Kitakyushu, Fukuoka, Japan aut Tagawa Jun Clinical Development Center, Asahi Kasei Pharma Corporation, Kanda Jinbocho, Chiyoda-ku, 1-105, 101-8101, Tokyo, Japan aut Hayakawa Toru Clinical Development Center, Asahi Kasei Pharma Corporation, Kanda Jinbocho, Chiyoda-ku, 1-105, 101-8101, Tokyo, Japan aut Aoki Nobuo Tokyo Medical and Dental University, Yushima, Bunkyo-ku, 1-5-45, 113-8510, Tokyo, Japan aut International Journal of Clinical Oncology Springer Japan 20/4(2015-08-01), 821-828 1341-9625 20:4<821 2015 20 10147 https://doi.org/10.1007/s10147-014-0768-1 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-014-0768-1 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Tamura Kazuo Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicine, Fukuoka University Hospital, Nanakuma, Jonan-ku, 7-45-1, 814-0180, Fukuoka, Fukuoka, Japan aut NATIONALLICENCE 700 1- Saito Hidehiko National Hospital Organization Nagoya Medical Center, Sannomaru, Naka-ku, 4-1-1, 460-0001, Nagoya, Aichi, Japan aut NATIONALLICENCE 700 1- Asakura Hidesaku Third Department of Internal Medicine, Kanazawa University Graduate School of Medical Science, Takaramachi, 13-1, 920-8641, Kanazawa, Ishikawa, Japan aut NATIONALLICENCE 700 1- Okamoto Kohji Center for Gastroenterology and Liver Disease, Kitakyushu Municipal Yahata Hospital, Nishihonmachi,Yahatahigashi-ku, 4-18-1, 805-0061, Kitakyushu, Fukuoka, Japan aut NATIONALLICENCE 700 1- Tagawa Jun Clinical Development Center, Asahi Kasei Pharma Corporation, Kanda Jinbocho, Chiyoda-ku, 1-105, 101-8101, Tokyo, Japan aut NATIONALLICENCE 700 1- Hayakawa Toru Clinical Development Center, Asahi Kasei Pharma Corporation, Kanda Jinbocho, Chiyoda-ku, 1-105, 101-8101, Tokyo, Japan aut NATIONALLICENCE 700 1- Aoki Nobuo Tokyo Medical and Dental University, Yushima, Bunkyo-ku, 1-5-45, 113-8510, Tokyo, Japan aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/4(2015-08-01), 821-828 1341-9625 20:4<821 2015 20 10147