Shi Yi-Fen, Zhou Shu-Juan, Sun Lan, Yu Kang, Chen Yi
Department of Hematology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325015, China.
Department of Hematology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325015, China.
Med Clin (Barc). 2020 Sep 25;155(6):235-241. doi: 10.1016/j.medcli.2019.11.009. Epub 2020 Mar 12.
The aim of this study was to evaluate the efficacy and toxicity of high-dose rituximab (HD-R) in combination with autologous stem cell transplantation (auto-SCT) in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL).
There were 22 patients in the HD-R group, to whom rituximab was administered during stem cell mobilization (375mg/m 1 day before and 7 days after chemotherapy) and after transplantation (1000mg/m on days +1 and +8). In the control group, the procedure was the same as that in the HD-R group but without rituximab. We observed the safety, tolerability, adverse effects and immune reconstitution of HD-R therapy. The log-rank test, univariate analysis and multivariate Cox regression analysis were used to evaluate the effect of HD-R on survival.
In total, 22 relapsed or refractory DLBCL patients were treated with HD-R. No dose-limiting toxicities were observed except for CD19 B cell reconstruction in the first 6 months after SCT. There were 20 relapsed or refractory DLBCL patients in the control group. The 3-year progression-free survival (PFS) and overall survival (OS) greatly improved in the HD-R group compared to that in the control group (63.8% vs. 35.0%, P=0.028 and 80.1% vs. 50.0%, P=0.035, respectively). The univariate and multivariate analyses demonstrated that HD-R and the time to relapse were independent prognostic factors for OS and PFS.
HD-R in combination with auto-SCT is a feasible and promising treatment for patients with relapsed or refractory DLBCL.
本研究旨在评估大剂量利妥昔单抗（HD-R）联合自体干细胞移植（auto-SCT）治疗复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）患者的疗效和毒性。
HD-R组有22例患者，在干细胞动员期间（化疗前1天和化疗后7天给予利妥昔单抗375mg/m²）及移植后（第+1天和第+8天给予1000mg/m²）给予利妥昔单抗。对照组的操作与HD-R组相同，但未使用利妥昔单抗。我们观察了HD-R治疗的安全性、耐受性、不良反应和免疫重建情况。采用对数秩检验、单因素分析和多因素Cox回归分析评估HD-R对生存的影响。
共有22例复发或难治性DLBCL患者接受了HD-R治疗。除了SCT后前6个月的CD19+B细胞重建外，未观察到剂量限制性毒性。对照组有20例复发或难治性DLBCL患者。与对照组相比，HD-R组的3年无进展生存期（PFS）和总生存期（OS）有显著改善（分别为63.8%对35.0%，P=0.028；80.1%对50.0%，P=0.035）。单因素和多因素分析表明，HD-R和复发时间是OS和PFS的独立预后因素。
HD-R联合auto-SCT是复发或难治性DLBCL患者一种可行且有前景的治疗方法。
