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机构地区:[1]厦门大学附属第一医院肿瘤中心肿瘤内科,厦门361003
出 处:《中国临床药学杂志》2014年第1期24-27,共4页Chinese Journal of Clinical Pharmacy
摘 要:目的比较中高危、高危弥漫性大B细胞淋巴瘤(IPI≥3)化疗后加与不加口服沙利度胺维持治疗的疗效。方法经病理学证实的弥漫性大B细胞淋巴瘤行CHOPE21或CHOP14方案化疗6周期后完全缓解(CR)40例,随机分为口服沙利度胺维持组(n=20)与观察组(n=20)。主要观察终点为无进展生存(PFS),次要观察终点为总生存(OS)和不良反应。结果维持组中位PFS为10.6个月,观察组为6.7个月(P=0.036)。维持组1、2、3年OS分别为80%、55%、45%,观察组分别为75%、45%、40%(P分别为0.705、0.527、0.749)。维持组仅有轻微血液学毒性。结论中高危、高危弥漫性大B细胞淋巴瘤(IPI≥3)化疗后予口服沙利度胺维持治疗可以延长PFS,但不能提高生存率,能否改善长期生存有待临床进一步加以研究。AIM To compare the efficacy of maintenance or non-maintenance therapy with thalidomide in diffuse large B-cell lymphoma (DLBCL)( IPI t〉 3) patients after chemotherapy. METHODS A total of 40 diagnosed patients with DLBCL firstly accepted the standard CHOPE21 or CHOP14 regime treatment for 6 cycles and got complete response (CR). The 40 patients were randomly assigned to thalidomide maintenance therapy group( n = 20) or observation group (n = 20).The primary end point was progression-free survival (PFS), the secondary end points were overall survival (OS) and adverse drug reaction. RESULTS The median PFS in the maintenance group was 10.6 months, whereas 6.7 months in the observation group( P = 0.036) ; the 1-year,2-year and 3-year OS rate were 80% ,55% and 45%, respec- tively for maintenance group, while the observation group were 75 %, 45 % and 40 % ( P = 0. 705 ; P = 0. 527 ; P = 0. 749). Only mild hematological toxicity were found in the maintenance group. CONCLUSION For patients with DLB- CL(IPI 〉/3) who responded after chemotherapy, thalidomide maintenance therapy can significantly prolong PFS , but not improve OS, if the maintenance therapy can enhance long-time survival is still unknown.
关 键 词:弥漫性大B细胞淋巴瘤 沙利度胺 维持治疗
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