利妥昔单抗联合CHOP方案治疗弥漫大B细胞性淋巴瘤的多中心临床研究

目的:观察利妥昔单抗联合环磷酰胺、长春新碱、多柔比星及泼尼松(CHOP方案)治疗新诊断的弥漫性大B细胞性淋巴瘤(DLBL)的临床疗效. 方法:2002年4月至2003年2月,共52例病人进入本研究.化疗采用标准的CHOP方案:d 1,环磷酰胺600 mg·m-2,长春新碱1.4 mg·m-2,多柔比星25 mg·m-2,泼尼松60 mg·m-2×5 d,每3 wk一个疗程,共6个疗程.利妥昔单抗静脉滴注剂量为375 mg·m-2,于化疗第一个疗程前2 d开始,每周输注1次(连续输注),连续4次(标准剂量)或6次(增强剂量);或于每疗程的CHOP方案化疗前2 d输注,每3周1次(间隔输注),输注4次(标准剂量)或6次(增强剂量).结果:50例病人进入临床疗效评估, 60 %获得完全缓解,总有效率为 100 %.其中,34例Ann Arbor分期为Ⅲ期或Ⅳ期的病人有15例获得完全缓解,完全缓解率为44 %.50例病人共随访了(8±s 5) wk, 2～30 wk,病人16 wk的无病生存(PFS)率为87 %.标准剂量组和增强剂量组疗效无显著差异,连续输注和间隔输注疗效差异亦无显著意义(P>0.05).所有病人在治疗过程中对本方案均能较好耐受,主要的不良反应为输注相关的不良反应(32 %)和化疗相关的血液学不良反应(20 %). 结论:利妥昔单抗联合CHOP方案可有效用于治疗新诊断的弥漫性大B细胞性淋巴瘤,它具有较高的完全缓解率,而且在治疗中不良反应较小.

Rituximab in combination with cyclophosphamide, vincristine, doxorubicin and prednisone for treatment of initially diagnosed diffuse large B cell lymphoma:a multi-center clinical study

AIM: To evaluate the efficacy of rituximab combined with cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) in treating the initially diagnosed diffuse large B cell lymphoma (DLBL). METHODS: From Apr. 2002 to Feb. 2003, 52 patients were enrolled in this study. Chemotherapy was conducted with cyclophosphamide 600 mg·m-2, vincristine 1.4 mg·m-2, doorubicin 25 mg·m-2 on d 1 and prednisone 60 mg·d-1 for successive 5 d (standard CHOP). There were 6 courses, 3 wk each. Rituximab 375 mg·m-2 was infused once a week, 2 d before the first course of chemotherapy (successive infusion) for 4 times on standard dose or for 6 times on extended dose. Or rituximab was infused once every 3 wk, 2 d before each CHOP (separated infusion) for 4 times on the schedule of standard dose or for 6 times on the extended dose. RESULTS: The complete response (CR) rate (60 %) and total effective (100 %) were achieved in 50 patients who were evaluated for efficacy, respectively. And among 34 patients in Ann Arbor stage III and IV, 15 patients were completely relieved. The complete effective rate was 44 %. Fifty patients were followed-up for (8±s 5) wk, 2-30 wk and estimated progress free survival (PFS) rate of 16 wk was 87 %. Standard and extend regimen were not different in effect, as well as the separated or concentrated infusion of rituximab (P>0.05). The regimen could be well tolerated, and the major adverse reactions were infusion-related response (32 %) and hematological toxicities (20 %). CONCLUSION: Rituximab in combined with CHOP can be successfully applied to the therapy of initially diagnosed diffuse large B cell lymphoma, with high CR rate and mild adverse reactions.