Epratuzumab with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated diffuse large B-cell lymphoma
Epratuzumab with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated diffuse large B-cell lymphoma
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DOI：
10.1182/blood-2011-02-336990
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发表时间：
2011-10-13
期刊：
影响因子：
20.3
通讯作者：
Witzig, Thomas E.
中科院分区：
文献类型：
--
作者：
Micallef, Ivana N. M.;Maurer, Matthew J.;Witzig, Thomas E.
大约60%的弥漫性大B细胞非霍奇金淋巴瘤(DLBCL)患者可以通过利妥昔单抗联合环磷酰胺、阿霉素、长春新碱和强的松(CHOP)化疗而治愈。Epratuzumab(E)是一种未标记的抗CD22单抗，对复发性DLBCL有疗效。这项2期试验测试了E和R-CHOP(ER-CHOP)联合治疗未经治疗的DLBCL的安全性和有效性。第二个目的是评估中期正电子发射断层扫描(PET)对DLBCL预后的预测效果。标准R-CHOP加E360 mg/m(2)静脉滴注，共6个周期。共有107名患者参加了这项研究。毒性与标准R-CHOP相似。在81例符合条件的患者中，CT扫描的总有效率为96%(CR/CRU)，PET的总有效率为88%。按意向处理分析，中位随访43个月时，107例患者3年无事件生存率(EFS)和总生存率(OS)分别为70%和80%。临时PET与EFS或OS无关。与215名接受R-CHOP治疗的患者相比，ER-CHOP患者的EFS得到了改善。ER-CHOP耐受性良好，作为一种联合治疗，结果似乎很有希望。这项研究在www.Clinicaltrials.gov上注册，编号为#NCT00301821。(血。2011；118(15)：4053-4061)
Approximately 60% of patients with diffuse large B-cell non-Hodgkin lymphoma (DLBCL) are curable with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemoimmunotherapy. Epratuzumab (E) is an unlabeled anti-CD22 monoclonal antibody with efficacy in relapsed DLBCL. This phase 2 trial tested the safety and efficacy of combining E with R-CHOP (ER-CHOP) in untreated DLBCL. A secondary aim was to assess the efficacy of interim positron emission tomography (PET) to predict outcome in DLBCL. Standard R-CHOP with the addition of E 360 mg/m(2) intravenously was administered for 6 cycles. A total of 107 patients were enrolled in the study. Toxicity was similar to standard R-CHOP. Overall response rate in the 81 eligible patients was 96% (74% CR/CRu) by computed tomography scan and 88% by PET. By intention to treat analysis, at a median follow-up of 43 months, the event-free survival (EFS) and overall survival (OS) at 3 years in all 107 patients were 70% and 80%, respectively. Interim PET was not associated with EFS or OS. Comparison with a cohort of 215 patients who were treated with R-CHOP showed an improved EFS in the ER-CHOP patients. ER-CHOP is well tolerated and results appear promising as a combination therapy. This study was registered at www.clinicaltrials.gov as #NCT00301821. (Blood. 2011; 118(15):4053-4061)