期刊
SCIENCE BULLETIN
卷 66, 期 24, 页码 2498-2505出版社
ELSEVIER
DOI: 10.1016/j.scib.2021.06.002
关键词
Haematopoietic cell transplantation; Haploidentical; Chronic graft-versus-host disease; Late effects; Antithymocyte globulin; GVHD-free; relapse-free survival
资金
- National Key Research and Development Program of China [2019YFC0840606]
- Ministry of Science and Technology
- National Natural Science Foundation of China [82070189, 81770189, 81621001, 81530046]
- Science and Technology Project of Guangdong Province of China [2016B030230003]
- Project of Health Collaborative Innovation of Guangzhou City [201704020214]
Randomized trial results indicate that a dosage of 7.5 mg/kg of ATG is more beneficial compared to 10 mg/kg in haplo-HCT patients, providing a better balance between GVHD and infection control.
Given that randomized studies testing the long-term impact of antithymocyte globulin (ATG) dosing are scarce, we report the results of an extended follow-up from the original trial. In our prospective, multicenter, randomized trial, 408 leukemia patients 14-65 years of age who underwent haploidentical hematopoietic cell transplantation (haplo-HCT) under our original Beijing Protocol were randomly assigned one-to-one to ATG doses of 7.5 mg/kg (n = 203, ATG-7.5) or 10 mg/kg (n = 205, ATG-10.0) at four sites. Extended follow-up (median 1968 d (range: 1300-2710 d) indicated comparable 5-year probabilities of moderate-to-severe chronic graft-versus-host disease (GVHD) (hazard ratio (HR): 1.384, 95% confidence interval (CI): 0.876-2.189, P = 0.164), nonrelapse mortality (HR: 0.814, 95% CI: 0.526-1.261, P = 0.357), relapse (HR: 1.521, 95% CI: 0.919-2.518, P = 0.103), disease-free survival (HR: 1.074, 95% CI: 0.783-1.473, P = 0.658), and GVHD-free/relapse-free survival (HR: 1.186, 95% CI: 0.904-1.555, P = 0.219) between groups (ATG-7.5 vs. ATG-10.0). The 5-year rate of late effects did not differ significantly. However, the cytomegalovirus/Epstein-Barr virus-related death rate was much higher in the ATG-10.0 cohort than in the ATG-7.5 cohort (9.8% vs. 1.5%; P = 0.003). In summary, patients undergoing haplo-HCT benefit from 7.5 mg/kg ATG compared to 10.0 mg/kg ATG based on a balance between GVHD and infection control. ATG (7.5 mg/kg) is potentially regarded as the standard regimen in the platform. These results support the optimization of ATG use in the Beijing Protocol, especially considering the potential economic advantage in developing countries. (c) 2021 Science China Press. Published by Elsevier B.V. and Science China Press. All rights reserved.
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