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      Antithymocyte Globulin for Matched Sibling Donor Transplantation in Patients With Hematologic Malignancies: A Multicenter, Open-Label, Randomized Controlled Study

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          Abstract

          PURPOSE

          The role of antithymocyte globulin (ATG) in preventing acute graft-versus-host disease (aGVHD) after HLA-matched sibling donor transplantation (MSDT) is still controversial.

          PATIENTS AND METHODS

          We performed a prospective, multicenter, open-label, randomized controlled trial (RCT) across 23 transplantation centers in China. Patients ages 40-60 years with standard-risk hematologic malignancies with an HLA-matched sibling donor were randomly assigned to an ATG group (4.5 mg/kg thymoglobulin plus cyclosporine [CsA], methotrexate [MTX], and mycophenolate mofetil [MMF]) and a control group (CsA, MTX, and MMF). The primary end point of this study was grade 2-4 aGVHD on day 100.

          RESULTS

          From November 2013 to April 2018, 263 patients were enrolled. The cumulative incidence rate of grade 2-4 aGVHD was significantly reduced in the ATG group (13.7%; 95% CI, 13.5% to 13.9%) compared with the control group (27.0%; 95% CI, 26.7% to 27.3%; P = .007). The ATG group had significantly lower incidences of 2-year overall chronic GVHD (27.9% [95% CI, 27.6% to 28.2%] v 52.5% [95% CI, 52.1% to 52.9%]; P < .001) and 2-year extensive chronic GVHD (8.5% [95% CI, 8.4% to 8.6%] v 23.2% [95% CI, 22.9% to 23.5%]; P = .029) than the control group. There were no differences between the ATG and control groups with regard to cytomegalovirus reactivation, Epstein-Barr virus reactivation, 3-year nonrelapse mortality (NRM), 3-year cumulative incidence of relapse (CIR), 3-year overall survival, or 3-year leukemia-free survival. Three-year GVHD relapse-free survival was significantly improved in the ATG group (38.7%; 95% CI, 29.9% to 47.5%) compared with the control group (24.5%; 95% CI, 16.9% to 32.1%; P = .003).

          CONCLUSION

          Our study is the first prospective RCT in our knowledge to demonstrate that ATG can effectively decrease the incidence of aGVHD after MSDT in the CsA era without affecting the CIR or NRM.

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          Graft-versus-host disease.

          James LM Ferrara, John Levine, Pavan Reddy … (2009)
          Haemopoietic-cell transplantation (HCT) is an intensive therapy used to treat high-risk haematological malignant disorders and other life-threatening haematological and genetic diseases. The main complication of HCT is graft-versus-host disease (GVHD), an immunological disorder that affects many organ systems, including the gastrointestinal tract, liver, skin, and lungs. The number of patients with this complication continues to grow, and many return home from transplant centres after HCT requiring continued treatment with immunosuppressive drugs that increases their risks for serious infections and other complications. In this Seminar, we review our understanding of the risk factors and causes of GHVD, the cellular and cytokine networks implicated in its pathophysiology, and current strategies to prevent and treat the disease. We also summarise supportive-care measures that are essential for management of this medically fragile population.
          Article 0 comments Cited 676 times – based on 0 reviews     Review now
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            Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group.

            Ben De Pauw, Thomas Walsh, J. Peter Donnelly … (2008)
            Invasive fungal diseases are important causes of morbidity and mortality. Clarity and uniformity in defining these infections are important factors in improving the quality of clinical studies. A standard set of definitions strengthens the consistency and reproducibility of such studies. After the introduction of the original European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group definitions, advances in diagnostic technology and the recognition of areas in need of improvement led to a revision of this document. The revision process started with a meeting of participants in 2003, to decide on the process and to draft the proposal. This was followed by several rounds of consultation until a final draft was approved in 2005. This was made available for 6 months to allow public comment, and then the manuscript was prepared and approved. The revised definitions retain the original classifications of "proven," "probable," and "possible" invasive fungal disease, but the definition of "probable" has been expanded, whereas the scope of the category "possible" has been diminished. The category of proven invasive fungal disease can apply to any patient, regardless of whether the patient is immunocompromised, whereas the probable and possible categories are proposed for immunocompromised patients only. These revised definitions of invasive fungal disease are intended to advance clinical and epidemiological research and may serve as a useful model for defining other infections in high-risk patients.
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              Mechanisms of action of antithymocyte globulin: T-cell depletion and beyond.

              M Mohty (2007)
              The success of allogeneic stem cell transplantation and solid-organ transplantation owes much to improvements in the immunosuppressive regimens that prevent graft-versus-host disease (GVHD) or suppress allograft rejection. A better understanding of the immune mechanisms underlying induction of immunological tolerance is the key to successful transplantation. Polyclonal antibodies such as antithymocyte globulins (ATG) have been used for decades. The common belief is that ATG efficacy relies on its capacity to deplete T lymphocytes. The aim of this review is to offer an overview of the recent findings that have been demonstrated in ATG's immunomodulatory activity. The polyclonal nature of ATG is reflected in its diverse effects on the immune system: (1) T-cell depletion in blood and peripheral lymphoid tissues through complement-dependent lysis and T-cell activation and apoptosis; (2) modulation of key cell surface molecules that mediate leukocyte/endothelium interactions; (3) induction of apoptosis in B-cell lineages; (4) interference with dendritic cell functional properties; and (5) induction of regulatory T and natural killer T cells. As a consequence, ATG provides multifaceted immunomodulation paving the way for future applications and suggesting that the use of ATG should be included in the immunosuppression therapeutic armamentarium to help reduce the incidence of organ rejection and GVHD.
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                Author and article information

                Journal
                Title: Journal of Clinical Oncology
                Abbreviated Title: JCO
                Publisher: American Society of Clinical Oncology (ASCO)
                ISSN (Print): 0732-183X
                ISSN (Electronic): 1527-7755
                Publication date Created: October 10 2020
                Publication date (Print): October 10 2020
                Volume: 38
                Issue: 29
                Pages: 3367-3376
                Affiliations
                [1 ]Peking University People’s Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, and Peking-Tsinghua Center for Life Sciences, Beijing, China
                [2 ]Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China
                [3 ]Department of Hematology, First Affiliated Hospital of Guangxi Medical University, Nanning, China
                [4 ]Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China
                [5 ]State Key Laboratory for Medical Genomics, Department of Hematology, Shanghai Institute of Hematology, and Collaborative Innovation Center of Hematology, Rui-Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
                [6 ]Union Hospital Affiliated With Huazhong University of Science and Technology, Wuhan, China
                [7 ]Department of Hematology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China
                [8 ]Department of Hematology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
                [9 ]Department of Hematology, Guangzhou First People’s Hospital, School of Medicine, South China University of Technology, Guangzhou, China
                [10 ]The First Hospital of Jilin University, Changchun, China
                [11 ]Guangdong General Hospital, Guangzhou, China
                [12 ]Third Hospital of Sun Yat-sen University, Guangzhou, China
                [13 ]Department of Hematology, Peking University First Hospital, Beijing, China
                [14 ]Department of Hematology, Xiangya Hospital, Central South University, Changsha, China
                [15 ]Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, China
                [16 ]Xinqiao Hospital Affiliated to Third Military Medical University, Chongqing, China
                [17 ]Bone Marrow Transplantation Center, The First Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang, China
                [18 ]The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China
                [19 ]The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China
                [20 ]Fujian Medical University Union Hospital, Fuzhou, China
                [21 ]Tangdu Hospital Air Force Medical University, Xi’an, China
                [22 ]Aerospace Center Hospital, Beijing, China
                [23 ]Southern Theater General Hospital of the Chinese People’s Liberation Army, Guangzhou, China
                Article
                DOI: 10.1200/JCO.20.00150
                PubMed ID: 32650683
                SO-VID: 9baa37b2-254d-4844-a8c5-0b8b78669f21
                Copyright © © 2020
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