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      Effect of Therapeutically Related Drugs on Coagulation-Anticoagulation Balance in Acute Promyelocytic Leukemia

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          Abstract

          Acute promyelocytic leukemia (APL) usually presents with a series of coagulation-anticoagulation disturbance. Early administration of All-trans retinoic acid (ATRA) can reduce the risk of bleeding, but the potential for thrombosis needs to be addressed in some cases. The role of arsenic agent in correcting coagulation disorder remains to be studied, but oral arsenic agent shows potential advantages in coagulation recovery compared with intravenous agent, and chemotherapy can aggravate the progress of coagulation disease. In addition to early application of ATRA, avoiding invasive procedures and transfusion support can reduce the risk of bleeding. Whether the administration of heparin, thrombomodulin, recombinant factor VIIa or antifibrinolytics reduces the risk of bleeding and thrombosis associated with APL remains to be further explored, and their routine use outside of clinical trials is not recommended. This article reviews the effects of related drugs on coagulation-anticoagulation balance in APL patients.

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          Management of acute promyelocytic leukemia: updated recommendations from an expert panel of the European LeukemiaNet

          Miguel Sanz, Pierre Fenaux, Martin S. Tallman … (2019)
          Since the comprehensive recommendations for the management of acute promyelocytic leukemia (APL) reported in 2009, several studies have provided important insights, particularly regarding the role of arsenic trioxide (ATO) in frontline therapy. Ten years later, a European LeukemiaNet expert panel has reviewed the recent advances in the management of APL in both frontline and relapse settings in order to develop updated evidence- and expert opinion–based recommendations on the management of this disease. Together with providing current indications on genetic diagnosis, modern risk-adapted frontline therapy, and salvage treatment, the review contains specific recommendations for the identification and management of the most important complications such as the bleeding disorder APL differentiation syndrome, QT prolongation, and other all- trans retinoic acid– and ATO-related toxicities, as well as recommendations for molecular assessment of the response to treatment. Finally, the approach to special situations is also discussed, including management of APL in children, elderly patients, and pregnant women. The most important challenges remaining in APL include early death, which still occurs before and during induction therapy, and optimizing treatment in patients with high-risk disease.
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            Efficacy and safety of recombinant human soluble thrombomodulin (ART-123) in disseminated intravascular coagulation: results of a phase III, randomized, double-blind clinical trial.

            Bruce Hirayama, Yoshio Yamamoto, T. Matsuda … (2006)
            Soluble thrombomodulin is a promising therapeutic natural anticoagulant that is comparable to antithrombin, tissue factor pathway inhibitor and activated protein C. We conducted a multicenter, double-blind, randomized, parallel-group trial to compare the efficacy and safety of recombinant human soluble thrombomodulin (ART-123) to those of low-dose heparin for the treatment of disseminated intravascular coagulation (DIC) associated with hematologic malignancy or infection. DIC patients (n = 234) were assigned to receive ART-123 (0.06 mg kg(-1) for 30 min, once daily) or heparin sodium (8 U kg(-1) h(-1) for 24 h) for 6 days, using a double-dummy method. The primary efficacy endpoint was DIC resolution rate. The secondary endpoints included clinical course of bleeding symptoms and mortality rate at 28 days. DIC was resolved in 66.1% of the ART-123 group, as compared with 49.9% of the heparin group [difference 16.2%; 95% confidence interval (CI) 3.3-29.1]. Patients in the ART-123 group also showed more marked improvement in clinical course of bleeding symptoms (P = 0.0271). The incidence of bleeding-related adverse events up to 7 days after the start of infusion was lower in the ART-123 group than in the heparin group (43.1% vs. 56.5%, P = 0.0487). When compared with heparin therapy, ART-123 therapy more significantly improves DIC and alleviates bleeding symptoms in DIC patients.
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              Acute promyelocytic leukemia: from highly fatal to highly curable.

              Zhen-Yi Wang, Zhu Chen (2008)
              Acute promyelocytic leukemia (APL) is a distinct subtype of acute myeloid leukemia. Morphologically, it is identified as the M3 subtype of acute myeloid leukemia by the French-American-British classification and cytogenetically is characterized by a balanced reciprocal translocation between chromosomes 15 and 17, which results in the fusion between promyelocytic leukemia (PML) gene and retinoic acid receptor alpha (RARalpha). It seems that the disease is the most malignant form of acute leukemia with a severe bleeding tendency and a fatal course of only weeks. Chemotherapy (CT; daunorubicin, idarubicin and cytosine arabinoside) was the front-line treatment of APL with a complete remission (CR) rate of 75% to 80% in newly diagnosed patients. Despite all these progresses, the median duration of remission ranged from 11 to 25 months and only 35% to 45% of the patients could be cured by CT. Since the introduction of all-trans retinoic acid (ATRA) in the treatment and optimization of the ATRA-based regimens, the CR rate was raised up to 90% to 95% and 5-year disease free survival (DFS) to 74%. The use of arsenic trioxide (ATO) since early 1990s further improved the clinical outcome of refractory or relapsed as well as newly diagnosed APL. In this article, we review the history of introduction of ATRA and ATO into clinical use and the mechanistic studies in understanding this model of cancer targeted therapy.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Clin Appl Thromb Hemost
                Journal ID (iso-abbrev): Clin Appl Thromb Hemost
                Journal ID (publisher-id): CAT
                Journal ID (hwp): spcat
                Title: Clinical and Applied Thrombosis/Hemostasis
                Publisher: SAGE Publications (Sage CA: Los Angeles, CA )
                ISSN (Print): 1076-0296
                ISSN (Electronic): 1938-2723
                Publication date (Electronic): 21 February 2022
                Publication date Collection: Jan-Dec 2022
                Volume: 28
                Electronic Location Identifier: 10760296221080166
                Affiliations
                [1 ]Department of Hematology, Ringgold 12636, universityZhengzhou University; People’s Hospital, Henan Provincial People’s Hospital, Zhengzhou, China
                Author notes
                [*]Kai Sun, Department of Hematology, Zhengzhou University People's Hospital, #7 Weiwu Road, Jinshui District, Zhengzhou, China. Email: sunkai@ 123456cellscience.org
                Author information
                https://orcid.org/0000-0003-3392-363X
                Article
                Publisher ID: 10.1177_10760296221080166
                DOI: 10.1177/10760296221080166
                PMC ID: 8864259
                PubMed ID: 35187963
                SO-VID: f0cfe453-82ec-46e4-b0e2-ba76719d9519
                Copyright © © The Author(s) 2022
                License:

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                Date received : 22 December 2021
                Date revision received : 21 January 2022
                Date accepted : 27 January 2022
                Funding
                Funded by: Henan Province Medical Science and Technology Tackling Program joint co-construction project;
                Award ID: No. LHGJ20190579, No. LHGJ20200049
                Funded by: National Natural Science Foundation of China, FundRef https://doi.org/10.13039/501100001809;
                Award ID: No. 81971508, No. 81471589
                Categories
                Subject: Review
                Custom metadata
                typesetter ts19
                cover-date January-December 2022

                Keywords: acute promyelocytic leukemia,coagulation,all-trans retinoic acid,chemotherapy,arsenic trioxide
                Data availability:
                Keywords: acute promyelocytic leukemia, coagulation, all-trans retinoic acid, chemotherapy, arsenic trioxide

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