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Improved Outcome of a Reduced Toxicity-Fludarabine, Cyclophosphamide, plus Antithymocyte Globulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia: Comparison of 2 Multicenter Prospective Studies.
Biol Blood Marrow Transplant. 2016 08; 22(8):1455-1459.BB

Abstract

Hematopoietic stem cell transplantation (HSCT) is a curative therapy for severe aplastic anemia (SAA); however, the optimal conditioning regimen for HSCT with an unrelated donor has not yet been defined. A previous study using a fludarabine (FLU), cyclophosphamide (Cy), and antithymocyte globulin (ATG) conditioning regimen (study A: 50 mg/kg Cy once daily i.v. on days -9, -8, -7, and -6; 30 mg/m(2) FLU once daily i.v. on days -5, -4, -3, and -2; and 2.5 mg/kg of ATG once daily i.v. on days -3, -2, and -1) demonstrated successful engraftment (100%) but had a high treatment-related mortality rate (32.1%). Therefore, given that Cy is more toxic than FLU, we performed a new phase II prospective study with a reduced-toxicity regimen (study B: 60 mg/kg Cy once daily i.v. on days -8 and -7; 40 mg/m(2) FLU once daily i.v. on days -6, -5, -4, -3, and -2; and 2.5 mg/kg ATG once daily i.v. on 3 days). Fifty-seven patients were enrolled in studies A (n = 28) and B (n = 29), and donor type hematologic recovery was achieved in all patients in both studies. The overall survival (OS) and event-free survival (EFS) rates of patients in study B was markedly improved compared with those in study A (OS: 96.7% versus 67.9%, respectively, P = .004; EFS: 93.3% versus 64.3%, respectively, P = .008). These data show that a reduced-toxicity conditioning regimen with FLU, Cy, and ATG may be an optimal regimen for SAA patients receiving unrelated donor HSCT.

Authors+Show Affiliations

Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Pediatrics, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.Department of Pediatrics, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.Department of Pediatrics, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.Department of Pediatrics, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.Department of Pediatrics, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.Department of Pediatrics, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.Department of Pediatrics, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.Department of Pediatrics, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.Department of Pediatrics, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.Department of Pediatrics, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.Department of Pediatrics, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.Department of Pediatrics, Ajou University School of Medicine, Suwon, Republic of Korea.Department of Pediatrics, Ajou University School of Medicine, Suwon, Republic of Korea.Department of Pediatrics, Hanyang University College of Medicine, Seoul, Republic of Korea.Department of Pediatrics, Pusan National University School of Medicine, Pusan, Republic of Korea.Department of Pediatrics, Chungnam National University College of Medicine, Daejeon, Republic of Korea.Department of Pediatrics, Chungnam National University College of Medicine, Daejeon, Republic of Korea.Department of Pediatrics, Ewha Woman's University School of Medicine, Seoul, Republic of Korea.Department of Pediatrics, Ewha Woman's University School of Medicine, Seoul, Republic of Korea.Department of Pediatrics, Chung-Ang University Hospital, Seoul, Republic of Korea.Department of Pediatrics, Inje University Haeundae Paik Hospital, Pusan, Republic of Korea.Department of Pediatrics, University of Ulsan College of Medicine, Ulsan University Hospital, Ulsan, Republic of Korea.Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: hsahn@snu.ac.kr.No affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Comparative Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27090956

Citation

Kang, Hyoung Jin, et al. "Improved Outcome of a Reduced Toxicity-Fludarabine, Cyclophosphamide, Plus Antithymocyte Globulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia: Comparison of 2 Multicenter Prospective Studies." Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation, vol. 22, no. 8, 2016, pp. 1455-1459.
Kang HJ, Hong KT, Lee JW, et al. Improved Outcome of a Reduced Toxicity-Fludarabine, Cyclophosphamide, plus Antithymocyte Globulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia: Comparison of 2 Multicenter Prospective Studies. Biol Blood Marrow Transplant. 2016;22(8):1455-1459.
Kang, H. J., Hong, K. T., Lee, J. W., Kim, H., Park, K. D., Shin, H. Y., Lee, S. H., Yoo, K. H., Sung, K. W., Koo, H. H., Lee, J. W., Chung, N. G., Cho, B., Kim, H. K., Koh, K. N., Im, H. J., Seo, J. J., Jung, H. J., Park, J. E., ... Ahn, H. S. (2016). Improved Outcome of a Reduced Toxicity-Fludarabine, Cyclophosphamide, plus Antithymocyte Globulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia: Comparison of 2 Multicenter Prospective Studies. Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation, 22(8), 1455-1459. https://doi.org/10.1016/j.bbmt.2016.04.003
Kang HJ, et al. Improved Outcome of a Reduced Toxicity-Fludarabine, Cyclophosphamide, Plus Antithymocyte Globulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia: Comparison of 2 Multicenter Prospective Studies. Biol Blood Marrow Transplant. 2016;22(8):1455-1459. PubMed PMID: 27090956.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improved Outcome of a Reduced Toxicity-Fludarabine, Cyclophosphamide, plus Antithymocyte Globulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia: Comparison of 2 Multicenter Prospective Studies. AU - Kang,Hyoung Jin, AU - Hong,Kyung Taek, AU - Lee,Ji Won, AU - Kim,Hyery, AU - Park,Kyung Duk, AU - Shin,Hee Young, AU - Lee,Soo Hyun, AU - Yoo,Keon Hee, AU - Sung,Ki Woong, AU - Koo,Hong Hoe, AU - Lee,Jae Wook, AU - Chung,Nak Gyun, AU - Cho,Bin, AU - Kim,Hack Ki, AU - Koh,Kyung Nam, AU - Im,Ho Joon, AU - Seo,Jong Jin, AU - Jung,Hyun Joo, AU - Park,Jun Eun, AU - Lee,Young Ho, AU - Lim,Young Tak, AU - Lim,Yeon Jung, AU - Kim,Sun Young, AU - Yoo,Eun Sun, AU - Ryu,Kyung Ha, AU - Lee,Jae Hee, AU - Park,Jeong-A, AU - Park,Sang Kyu, AU - Ahn,Hyo Seop, AU - ,, Y1 - 2016/05/08/ PY - 2016/02/14/received PY - 2016/04/04/accepted PY - 2016/4/20/entrez PY - 2016/4/20/pubmed PY - 2018/1/27/medline KW - Antithymocyte globulin (ATG) KW - Cyclophosphamide KW - Fludarabine KW - Severe aplastic anemia KW - Thymoglobulin KW - Unrelated donor SP - 1455 EP - 1459 JF - Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation JO - Biol. Blood Marrow Transplant. VL - 22 IS - 8 N2 - Hematopoietic stem cell transplantation (HSCT) is a curative therapy for severe aplastic anemia (SAA); however, the optimal conditioning regimen for HSCT with an unrelated donor has not yet been defined. A previous study using a fludarabine (FLU), cyclophosphamide (Cy), and antithymocyte globulin (ATG) conditioning regimen (study A: 50 mg/kg Cy once daily i.v. on days -9, -8, -7, and -6; 30 mg/m(2) FLU once daily i.v. on days -5, -4, -3, and -2; and 2.5 mg/kg of ATG once daily i.v. on days -3, -2, and -1) demonstrated successful engraftment (100%) but had a high treatment-related mortality rate (32.1%). Therefore, given that Cy is more toxic than FLU, we performed a new phase II prospective study with a reduced-toxicity regimen (study B: 60 mg/kg Cy once daily i.v. on days -8 and -7; 40 mg/m(2) FLU once daily i.v. on days -6, -5, -4, -3, and -2; and 2.5 mg/kg ATG once daily i.v. on 3 days). Fifty-seven patients were enrolled in studies A (n = 28) and B (n = 29), and donor type hematologic recovery was achieved in all patients in both studies. The overall survival (OS) and event-free survival (EFS) rates of patients in study B was markedly improved compared with those in study A (OS: 96.7% versus 67.9%, respectively, P = .004; EFS: 93.3% versus 64.3%, respectively, P = .008). These data show that a reduced-toxicity conditioning regimen with FLU, Cy, and ATG may be an optimal regimen for SAA patients receiving unrelated donor HSCT. SN - 1523-6536 UR - https://www.unboundmedicine.com/medline/citation/27090956/Improved_Outcome_of_a_Reduced_Toxicity_Fludarabine_Cyclophosphamide_plus_Antithymocyte_Globulin_Conditioning_Regimen_for_Unrelated_Donor_Transplantation_in_Severe_Aplastic_Anemia:_Comparison_of_2_Multicenter_Prospective_Studies_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1083-8791(16)30021-0 DB - PRIME DP - Unbound Medicine ER -