Optimizing antithymocyte globulin dosing in haploidentical hematopoietic cell transplantation:long-term follow-up of a multicenter,randomized controlled trial

• 作者: Yu Wang Qi-Fa Liu Ren Lin Ting Yang Ya-Jing Xu Xiao-Dong Mo Xiao-Jun Huang
• 来源期刊: 科学通报（英文版）
• 年，卷（期）: 2021,（24）
• 所属期刊栏目: ARTICLES
• 页码范围: 2498-2505
• 页数: 8页
• 语种: 英文

摘要

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,multi-center,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 probabil-ities of moderate-to-severe chronic graft-versus-host disease (GVHD) (hazard ratio (HR):1.384,95％ con-fidence 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％Cl:0.783-1.473,P =0.658),and GVHD-free/relapse-free survival (HR:1.186,95％ CI:0.904-1.555,P =o.219) between groups (ATG-7.5 vs.ATG-10.0).The 5-year rate of late effects did not differ signifi-cantly.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.