Despite the proven efficacy of anti-T-cell or antithymocyte globulin (ATG) for chronic graft-versus-host disease (GVHD) prevention in transplantation from an unrelated donor, dosing protocols and the effects of ATG on relapse and infection remain controversial. In the setting of transplantation from an HLA-matched sibling (MSD-T), few randomized studies have been conducted. We conducted a prospective, single-center, open-label, randomized study of low-dose thymoglobulin (2.5 mg/kg) for chronic GVHD prevention. A total of 120 patients with acute leukemia were randomly assigned in a 1:1 ratio. After a median follow-up of 27 months, the cumulative incidence of chronic GVHD in the ATG and non-ATG groups was 25.0% and 65.4% (p < 0.001), respectively. The ATG group had an increased relapse rate compared with the non-ATG-group (20.0% vs. 9.3%; p = 0.055), with risks that differed according to cytogenetic subgroup (high-risk, 29.6% vs. 9.3%, p = 0.042; non-high-risk, 12.2% vs. 9.2%, p = 0.596). Chronic GVHD-free and relapse-free survival (cGRFS) was higher in the ATG group (46.7% vs. 19.4%; p = 0.070), and the difference was significant in a cytogenetic non-high-risk subgroup (45.5% vs. 0%; p = 0.038). No differences were observed in other survival outcomes. Improved physical components in quality-of-life scores were observed in the ATG group at 12 months after transplantation. A higher rate of Epstein–Barr virus reactivation was observed in the ATG group (21.8% vs. 5.1%; p = 0.013), whereas no between-group differences for other complications. In conclusion, the low-dose thymoglobulin effectively prevented chronic GVHD in MSD-T, resulting in improvement in quality-of-life and cGRFS, whereas the necessity of caution for high-risk acute leukemia.

中文翻译：

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低剂量胸腺球蛋白预防 HLA 匹配同胞供体移植中的慢性移植物抗宿主病

尽管已证明抗 T 细胞或抗胸腺细胞球蛋白 (ATG) 可预防来自无关供体的慢性移植物抗宿主病 (GVHD)，但给药方案和 ATG 对复发和感染的影响仍存在争议。在从 HLA 匹配的兄弟姐妹 (MSD-T) 移植的情况下，很少进行随机研究。我们对低剂量胸腺球蛋白 (2.5 mg/kg) 预防慢性 GVHD 进行了一项前瞻性、单中心、开放标签、随机研究。共有 120 名急性白血病患者按 1:1 的比例随机分配。中位随访 27 个月后，ATG 组和非 ATG 组慢性 GVHD 的累积发生率分别为 25.0% 和 65.4%（p < 0.001)，分别。与非 ATG 组相比，ATG 组的复发率增加（20.0% 对 9.3%；p  = 0.055），风险因细胞遗传亚组而异（高风险，29.6% 对 9.3%，p  = 0.042；非高风险，12.2% 与 9.2%，p  = 0.596）。ATG 组的慢性无 GVHD 和无复发生存率 (cGRFS) 较高（46.7% 对 19.4%；p  = 0.070），在细胞遗传学非高风险亚组中差异显着（45.5% 对0%; p = 0.038）。在其他生存结果中没有观察到差异。在移植后 12 个月，在 ATG 组中观察到生活质量评分中物理成分的改善。在 ATG 组中观察到更高的 Epstein-Barr 病毒再激活率（21.8% 对 5.1%；p  = 0.013），而在其他并发症方面没有组间差异。总之，低剂量胸腺球蛋白有效地预防了 MSD-T 中的慢性 GVHD，从而改善了生活质量和 cGRFS，而对于高危急性白血病则需要谨慎。