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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(英文)

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

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【作者】 李军民沈杨陈方源谢毅王椿侯健洪小南吴德沛陈嘉侯明徐建民沈志祥

【Author】 LI Jun-min 1, SHEN Yang 1, CHEN Fang-yuan 2, XIE Yi 3, WANG Chun 4, HOU Jian 5, HONG Xiao-nan 6, WU De-pei 7, CHEN Jia 8, HOU Ming 9, XU Jian-min 10, SHEN Zhi-xiang 1 (1.Department of Hematology, Shanghai Institute of Hematology, Ruijin Hospital Affiliated to Shanghai Second Medical University, SHANGHAI 200025, China; 2.Department of Hematology, Renji Hospital Affiliated to Shanghai Second Medical University, SHANGHAI 200001, China; 3.Department of Hematology, Huashan Hospital Affiliated to Fudan University, SHANGHAI 200031, China; 4.Department of Hematology, The First People’s Hospital Affiliated to Shanghai Jiaotong University, SHANGHAI 200080, China; 5.Department of Hematology, Changzheng Hospital Affiliated to Second Military Medical University, SHANGHAI 200002, China; 6.Department of Chemotherapy, Cancer Hospital Affiliated to Fudan University, SHANGHAI 200032, China; 7.Department of Hematology, The First Hospital Affiliated to Suzhou University, Suzhou JIANGSU 215005, China; 8.Department of Oncology, Jiangsu Cancer Hospital, Nanjing JIANGSU 210009, China; 9.Department of Oncology, Affiliated Hospital of Shandong Medical University, Ji’nan SHANDONG 250012, China; 10.Department of Hematology, Zhongshan Hospital Affiliated to Fudan University, SHANGHAI 200032, China)

【机构】 上海第二医科大学附属瑞金医院、上海血液研究所血液科上海第二医科大学附属仁济医院血液科复旦大学附属华山医院血液科上海交通大学附属第一人民医院血液科第二军医大学附属长征医院血液科复旦大学附属肿瘤医院化疗科苏州大学附属第一医院血液科江苏肿瘤医院肿瘤科山东医科大学附属医院肿瘤科复旦大学附属中山医院血液科上海第二医科大学附属瑞金医院、上海血液研究所血液科 上海200025上海200025上海200001上海200031上海200080上海200002上海200032江苏苏州215005江苏南京210009山东济南250012上海200025

【摘要】 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 :2 0 0 2年 4月至 2 0 0 3年 2月 ,共 5 2例病人进入本研究。化疗采用标准的CHOP方案 :d 1,环磷酰胺 6 0 0mg·m- 2 ,长春新碱 1.4mg·m- 2 ,多柔比星 2 5mg·m- 2 ,泼尼松 6 0mg·m- 2 × 5d ,每 3wk一个疗程 ,共 6个疗程。利妥昔单抗静脉滴注剂量为 375mg·m- 2 ,于化疗第一个疗程前 2d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 2d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 :5 0例病人进入临床疗效评估 ,6 0 %获得完全缓解 ,总有效率为 10 0 %。其中 ,34例AnnArbor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 4 4%。 5 0例病人共随访了 (8±s 5 )wk ,2~ 30wk ,病人 16wk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 .0 5 )。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 (2 0 % )。 结论 :利妥昔单?

【Abstract】 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.

  • 【文献出处】 中国新药与临床杂志 ,Chinese Journal of New Drugs and Clinical Remedies , 编辑部邮箱 ,2004年01期
  • 【分类号】R733.1
  • 【被引频次】3
  • 【下载频次】113
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