Hu Xin, Zeng Min, Yang Shun-E, Liang Xiao, Ding Shan-Shan, Guo Li, Li Shan, Wen Shu-Juan
Department of Lymphoma Department of Chest Radiotherapy, Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang, Urumqi, China.
Medicine (Baltimore). 2017 Nov;96(45):e8494. doi: 10.1097/MD.0000000000008494.
This study aimed to evaluate the efficacy and safety of rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for treating patients with diffuse large B-cell lymphoma (DLBCL).
A total of 144 patients with DLBCL were randomly divided into intervention group and control group, 72 patients in each group. The patients in the control group received cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy, while the participants in the intervention group received R-CHOP. The primary endpoint was relapse-free survival (RFS) and the secondary endpoints were overall survival rate (OSR) and adverse events (AEs).
One hundred thirty-four patients completed the study. The intervention with R-CHOP did not show greater efficacy than CHOP in the estimated median follow-up time (intervention group 33 months vs control group 29 months, P = .15). In addition, no significant differences in the 5-year RFS (intervention group 81% vs placebo group 76%, P = .28) or the 5-year OSR (intervention group 93% vs placebo group 91%, P = .53) were found between the 2 groups. The AEs were also similar between the 2 groups.
This study demonstrated that R-CHOP, when compared with CHOP alone, could not improve the RFS and OS of patients with DLBCL. Additionally, both groups had similar safety profiles.
本研究旨在评估利妥昔单抗联合环磷酰胺、多柔比星、长春新碱和泼尼松（R-CHOP）治疗弥漫性大B细胞淋巴瘤（DLBCL）患者的疗效和安全性。
总共144例DLBCL患者被随机分为干预组和对照组，每组72例。对照组患者接受环磷酰胺、多柔比星、长春新碱和泼尼松（CHOP）化疗，而干预组患者接受R-CHOP治疗。主要终点是无复发生存期（RFS），次要终点是总生存率（OSR）和不良事件（AE）。
134例患者完成了研究。在估计的中位随访时间内，R-CHOP干预组的疗效并不比CHOP组更好（干预组33个月，对照组29个月，P = 0.15）。此外，两组之间在5年无复发生存率（干预组81% vs 安慰剂组76%，P = 0.28）或5年总生存率（干预组93% vs 安慰剂组91%，P = 0.53）方面未发现显著差异。两组的不良事件也相似。
本研究表明，与单独使用CHOP相比，R-CHOP不能改善DLBCL患者的无复发生存期和总生存期。此外，两组的安全性概况相似。
