Chang Ying-Jun, Xu Lan-Ping, Wang Yu, Zhang Xiao-Hui, Chen Huan, Chen Yu-Hong, Wang Feng-Rong, Han Wei, Sun Yu-Qian, Yan Chen-Hua, Tang Fei-Fei, Huo Ming-Rui, Zhao Xiang-Yu, Mo Xiao-Dong, Liu Kai-Yan, Huang Xiao-Jun
Peking University People's Hospital & Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, China.
Peking-Tsinghua Center for Life Sciences, Beijing, 100871, China.
Bone Marrow Transplant. 2020 Jul;55(7):1326-1336. doi: 10.1038/s41409-020-0928-z. Epub 2020 May 8.
To define the efficacy of a single dose of 375 mg/m rituximab for DSA-positive patients with 2000 ≤ MFI < 10,000, we enrolled a prospective clinical cohort including patients with positive DSA treated with rituximab (n = 55, cohort A), a matched-pair cohort including cases with negative DSA (n = 110, cohort B) and a historical cohort including subjects with 2000 ≤ MFI < 10,000 without receiving any treatment for DSA (n = 22, cohort C). The incidences of primary poor graft function (PGF) in cohort A and cohort B were 5% and 1% (P = 0.076), respectively, both of which were lower than that in cohort C (27%, P < 0.001, for all). Rituximab was associated with a reduced incidence of primary PGF (HR 0.200, P = 0.023). The 3-year nonrelapse mortality of patients in cohort A and cohort B were 23% and 24%, respectively, both of which were lower than that in the cohort C (37%), although no statistical significance was observed. These results led to a low 3-year overall survival in patients in the cohort C (58%) compared with those in the cohort A (71%) and the cohort B (73%). We suggest that a single dose of rituximab could be effectively used to prevent the onset of primary PGF. The prospective cohort of this study is registered at http://www.chictr.org.cn/ChiCTR-OPC-15006672.
为确定单剂量375mg/m利妥昔单抗对DSA阳性且2000≤MFI＜10000患者的疗效，我们纳入了一个前瞻性临床队列，其中包括接受利妥昔单抗治疗的DSA阳性患者（n = 55，队列A）、一个匹配对队列，其中包括DSA阴性病例（n = 110，队列B）以及一个历史队列，其中包括2000≤MFI＜10000且未接受任何DSA治疗的受试者（n = 22，队列C）。队列A和队列B中原发性移植物功能不良（PGF）的发生率分别为5%和1%（P = 0.076），两者均低于队列C中的发生率（27%，P＜0.001，所有比较均如此）。利妥昔单抗与原发性PGF发生率降低相关（HR 0.200，P = 0.023）。队列A和队列B中患者的3年无复发生存率分别为23%和24%，两者均低于队列C中的发生率（37%），尽管未观察到统计学显著性。这些结果导致队列C中患者的3年总生存率较低（58%），相比之下队列A中患者为71%，队列B中患者为73%。我们建议单剂量利妥昔单抗可有效用于预防原发性PGF的发生。本研究的前瞻性队列已在http://www.chictr.org.cn/ChiCTR-OPC-15006672注册。
