Article ; Online: Thrombomodulin alfa treatment in patients with acute promyelocytic leukemia and disseminated intravascular coagulation: a retrospective analysis of an open-label, multicenter, post-marketing surveillance study cohort.
2014 Volume 133, Issue 5, Page(s) 772–781
Abstract: Introduction: Patients with acute promyelocytic leukemia (APL) can develop disseminated intravascular coagulation (DIC) that results in life-threatening hemorrhagic complications. Studies regarding the safety and efficacy of thrombomodulin alfa (TM-α; ... ...
| Abstract | Introduction: Patients with acute promyelocytic leukemia (APL) can develop disseminated intravascular coagulation (DIC) that results in life-threatening hemorrhagic complications. Studies regarding the safety and efficacy of thrombomodulin alfa (TM-α; recombinant human soluble thrombomodulin) in patients with APL and DIC are limited. Materials and methods: A retrospective evaluation was performed on a cohort of 172 patients with APL from an open-label, multicenter, post-marketing surveillance study of TM-α. Results: Of the 172 patients, 31 were relapse/refractory APL patients, and 141 were newly diagnosed APL patients. Within the first 30 days, 24 patients (14.0%) died, and six of those deaths (3.5%) were due to hemorrhage. In total, 12 patients (7.0%) had severe hemorrhagic complications. Both the early death rate due to hemorrhage as well as the severe hemorrhage rate did not exceed those in some recent population-based studies of patients with APL. Forty-nine patients received TM-α prior to the initiation of antileukemic treatment, and one patient experienced hemorrhagic early death (ED), suggesting that early TM-α treatment appeared to result in a reduction in the hemorrhagic ED rate. Moreover, TM-α improved coagulopathy regardless of concomitant all-trans retinoic acid treatment. Conclusions: This study confirmed the safety and efficacy of TM-α in daily clinical practice for patients with APL and DIC. TM-α appeared to reduce hemorrhagic early deaths due to DIC in patients with APL who were receiving antileukemic treatment. |
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| MeSH term(s) | Adolescent ; Adult ; Aged ; Aged, 80 and over ; Child ; Cohort Studies ; Disseminated Intravascular Coagulation/drug therapy ; Female ; Humans ; Leukemia, Promyelocytic, Acute/blood ; Leukemia, Promyelocytic, Acute/drug therapy ; Male ; Middle Aged ; Product Surveillance, Postmarketing ; Recombinant Proteins/adverse effects ; Recombinant Proteins/therapeutic use ; Retrospective Studies ; Thrombomodulin/therapeutic use ; Young Adult |
| Chemical Substances | Recombinant Proteins ; THBD protein, human ; Thrombomodulin |
| Language | English |
| Publishing date | 2014-05 |
| Publishing country | United States |
| Document type | Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 121852-9 |
| ISSN | 1879-2472 ; 0049-3848 |
| ISSN (online) | 1879-2472 |
| ISSN | 0049-3848 |
| DOI | 10.1016/j.thromres.2014.02.025 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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