利妥昔单抗联合CHOP与单用CHOP方案治疗初治弥漫大B细胞型淋巴瘤的对比研究

CHOP chemotherapy plus rituximab compared with CHOP alone in patients with previously untreated diffuse large-B-cell lymphoma

目的:比较利妥昔单抗(商品名:美罗华)联合CHOP(环磷酰胺,阿霉素,长春新碱和泼尼松)与单用CHOP方案化疗治疗弥漫大B细胞淋巴瘤(diffuse large B cell lymphoma,DLBCL)的临床疗效。方法:根据患者的意愿,49例DLBCL患者分别接受6疗程CHOP方案或CHOP加利妥昔单抗方案化疗,每3周1疗程,共6个疗程。结果:R-CHOP组的CR率高于CHOP组,但差异无统计学意义(82.6%VS 65.4%,P=0.173)。中位随访时间为35月(4-66月),R-CHOP组及CHOP组的3年OS分别为75.0%±19.6%,54.9%±20.4%,P=0.043;而3年EFS分别为69.7%±20.9%,45.8%±20.6%,P=0.029。R-CHOP组的3年OS及EFS优于CHOP组,差异有统计学意义。两组患者的不良反应无明显差别。结论:与单用CHOP方案相比,利妥昔单抗联合CHOP方案明显提高DLBCL患者的EFS及OS,而不良反应无明显增加。

Objective：To compare the clinical outcome of cyclophosphamide,doxorubicin,vincristine,and prednisone（CHOP） to rituximab plus CHOP（R-CHOP） in adult patients with diffuse large-B-cell lymphoma.Methods： Previously untreated patients with diffuse large-B-cell lymphoma were assigned according to the Patients＇ intention to receive either six cycles of CHOP every three weeks or six cycles of CHOP plus rituximab chemotherapy regimen.Results： The rate of complete response was higher in the group that received CHOP plus rituximab than in the group that received CHOP alone（82.6% VS 65.4%,P=0.173）,but no statistical difference was found between the groups.With a median follow-up of 35 months,the 3-year overall survival rate and disease-free rate were significantly higher in the CHOP-plus-rituximab group（P=0.043 and P=0.029,respectively）.Clinically relevant toxicity was not significantly greater in group of CHOP plus rituximab.Conclusion： The combination of rituximab to the CHOP regimen significantly prolongs disease-free and overall survival in adult patients with diffuse large-B-cell lymphoma,without a clinically significant increase in toxicity.