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联合使用依帕珠单抗和利妥昔单抗治疗取得持久完全缓解:一项针对复发性、惰性、非霍奇金淋巴瘤的国际多中心2期研究的最终结果

Durable complete responses from therapy with combined epratuzumab and rituximab: final results from an international multicenter, phase 2 study in recurrent, indolent, non-Hodgkin lymphoma.

作者信息

Leonard John P, Schuster Stephen J, Emmanouilides Christos, Couture Felix, Teoh Nick, Wegener William A, Coleman Morton, Goldenberg David M

机构信息

Center for Lymphoma and Myeloma, Division of Hematology/Oncology, Weill Cornell Medical College and New York Presbyterian Hospital, New York, New York, USA.

出版信息

Cancer. 2008 Nov 15;113(10):2714-23. doi: 10.1002/cncr.23890.

DOI:10.1002/cncr.23890
PMID:18853418
Abstract

BACKGROUND

In this international, multicenter trial, the authors evaluated rituximab (anti-CD20) plus epratuzumab (anti-CD22) in patients with postchemotherapy relapsed/refractory, indolent non-Hodgkin lymphoma (NHL), including long-term efficacy.

METHODS

Forty-nine patients with follicular NHL (FL) (N = 41) or small lymphocytic lymphoma (SLL) (N = 7) received intravenous epratuzumab 360 mg/m2 and then intravenous rituximab 375 mg/m2 weekly x4. The regimen was tolerated well.

RESULTS

Twenty-two of 41 patients with FL (54%) had an objective response (OR), including 10 (24%) complete responses (CR) (CR/unconfirmed CR [CRu]), whereas 4 of 7 patients with SLL (57%) had ORs, including 3 (43%) with CR/CRu. Rituximab-naive patients (N = 34) had an OR rate of 50% (26% CR/CRu rate), whereas patients who previously responded to rituximab (N = 14) had an OR rate of 64% (29% CR/CRu rate). An OR rate of 85% was observed in patients with FL who had Follicular Lymphoma International Prognostic Index (FLIPI) risk scores of 0 or 1 (N = 13), whereas 28 patients with intermediate or high-risk FLIPI scores (> or =2) had an OR rate of 39% (18% CR/CRu rate). In patients with FL, the median response duration was 13.4 months, and that duration increased to 29.1 months for 10 patients who had a CR/CRu, including 4 patients who had durable responses with remissions that continued for >4 years. In patients with SLL, the median response duration was 20 months, including 1 patient who had a response that continued for >3 years.

CONCLUSIONS

The combination of epratuzumab and rituximab induced durable responses in patients with recurrent, indolent NHL.

摘要

背景

在这项国际多中心试验中,作者评估了利妥昔单抗(抗CD20)联合依帕珠单抗(抗CD22)用于化疗后复发/难治性惰性非霍奇金淋巴瘤(NHL)患者的疗效,包括长期疗效。

方法

49例滤泡性NHL(FL)患者(n = 41)或小淋巴细胞淋巴瘤(SLL)患者(n = 7)接受静脉注射依帕珠单抗360mg/m²,随后静脉注射利妥昔单抗375mg/m²,每周1次,共4次。该方案耐受性良好。

结果

41例FL患者中有22例(54%)获得客观缓解(OR),包括10例(24%)完全缓解(CR)(CR/未确认的CR [CRu]),而7例SLL患者中有4例(57%)获得OR,包括3例(43%)CR/CRu。初治利妥昔单抗患者(n = 34)的OR率为50%(CR/CRu率为26%),而先前对利妥昔单抗有反应的患者(n = 14)的OR率为64%(CR/CRu率为29%)。滤泡性淋巴瘤国际预后指数(FLIPI)风险评分为0或1的FL患者(n = 13)的OR率为85%,而28例FLIPI评分中或高风险(≥2)的患者的OR率为39%(CR/CRu率为18%)。在FL患者中,中位缓解持续时间为13.4个月,10例CR/CRu患者的缓解持续时间延长至29.1个月,其中4例患者有持续超过4年的持久缓解。在SLL患者中,中位缓解持续时间为20个月,包括1例缓解持续超过3年的患者。

结论

依帕珠单抗和利妥昔单抗联合用药可使复发惰性NHL患者获得持久缓解。

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