We compared relapse incidence (RI) post-unrelated transplantation with post-transplant cyclophosphamide (PTCy) versus no PTCy graft-versus-host disease (GVHD) prophylaxis, in 7049 acute myeloid leukemia (AML) patients in remission, 707 with PTCy, and 6342 without (No PTCy). The patients in the PTCy group were younger, 52.7 versus 56.6 years (p < .001). There were more 9/10 donors in the PTCy group, 33.8% versus 16.4% (p < .001), and more received myeloablative conditioning, 61.7% versus 50.2% (p < .001). In the No PTCy group, 87.7% of patients received in vivo T-cell depletion. Neutrophil and platelet engraftment were lower in the PTCy versus No PTCy group, 93.8% and 80.9% versus 97.6% and 92.6% (p < .001). RI was not significantly different in the PTCy versus the No PTCy group, hazard ratio (HR) of 1.11 (95% confidence interval [CI] 0.9–1.37) (p = .31). Acute GVHD grades II–IV and III–IV, were significantly lower in the PTCy versus the No PTCy group, HR of 0.74 (95% CI 0.59–0.92, p = .007) and HR = 0.56 (95% CI 0.38–0.83, p = .004), as were total and extensive chronic GVHD, HRs of 0.5 (95% CI 0.41–0.62, p < .001) and HR = 0.31 (95% CI 0.22–0.42, p < .001). Non-relapse mortality (NRM) was significantly lower with PTCy versus the No PTCy group, HR of 0.67 (95% CI 0.5–0.91, p = .007). GVHD-free, relapse-free survival (GRFS) was higher in the PTCy versus the No PTCy group, HR of 0.69 (95% CI 0.59–0.81, p = .001). Leukemia-free survival (LFS) and overall survival (OS) did not differ between the groups. In summary, we observed comparable RI, OS, and LFS, significantly lower incidences of GVHD and NRM, and significantly higher GRFS in AML patients undergoing unrelated donor-hematopoietic stem cell transplantation with PTCy versus No PTCy GVHD prophylaxis.

中文翻译：

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急性髓系白血病患者进行无关同种异体干细胞移植后环磷酰胺与传统抗移植物抗宿主病预防的复发率相当：代表欧洲血液和骨髓移植学会急性白血病工作组的一项研究


我们比较了 7049 名缓解期急性髓系白血病 (AML) 患者、707 名接受 PTCy 的患者和 707 名接受移植后环磷酰胺 (PTCy) 预防的非相关移植患者的复发率 (RI) 与不接受 PTCy 移植物抗宿主病 (GVHD) 预防的情况。 6342 无（无 PTCy）。 PTCy 组的患者更年轻，分别为 52.7 岁和 56.6 岁 ( p < .001)。 PTCy 组中有更多的 9/10 捐献者，分别为 33.8% 与 16.4% ( p < .001)，并且接受清髓性调理的人数更多，分别为 61.7% 与 50.2% ( p < .001)。在无 PTCy 组中，87.7% 的患者接受了体内 T 细胞去除。与无 PTCy 组相比，PTCy 组的中性粒细胞和血小板植入较低，分别为 93.8% 和 80.9% vs 97.6% 和 92.6% ( p < .001)。 PTCy 组与无 PTCy 组的 RI 没有显着差异，风险比 (HR) 为 1.11（95% 置信区间 [CI] 0.9–1.37）（ p = .31）。 PTCy 组与无 PTCy 组相比，II-IV 级和 III-IV 级急性 GVHD 显着降低，HR 为 0.74（95% CI 0.59-0.92， p = 0.007），HR = 0.56（95% CI 0.38-0.83） ， p = .004），总体和广泛的慢性 GVHD 也是如此，HR 为 0.5（95% CI 0.41–0.62， p < .001），HR = 0.31（95% CI 0.22–0.42， p < .001）。与无 PTCy 组相比，PTCy 组的非复发死亡率 (NRM) 显着降低，HR 为 0.67（95% CI 0.5–0.91， p = .007）。 PTCy 组的无 GVHD、无复发生存期 (GRFS) 高于无 PTCy 组，HR 为 0.69 (95% CI 0.59–0.81， p = .001)。各组之间无白血病生存期（LFS）和总生存期（OS）没有差异。 总之，我们观察到接受非亲缘供体造血干细胞移植并接受 PTCy 预防的 AML 患者与不接受 PTCy GVHD 预防的患者 RI、OS 和 LFS 相当，GVHD 和 NRM 发生率显着降低，GRFS 显着升高。