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苯达莫司汀、来那度胺和利妥昔单抗用于复发和难治性淋巴瘤的I期研究。

A phase I study of bendamustine, lenalidomide and rituximab in relapsed and refractory lymphomas.

作者信息

Cheson Bruce D, Crawford Jeanette

机构信息

Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC, USA.

出版信息

Br J Haematol. 2015 May;169(4):528-33. doi: 10.1111/bjh.13321. Epub 2015 Mar 7.

DOI:10.1111/bjh.13321
PMID:25752751
Abstract

Many patients with non-Hodgkin (NHL) or Hodgkin lymphoma (HL) relapse or are refractory to initial therapy and require additional options. Bendamustine (B), lenalidomide (L) and rituximab (R) each have activity in this setting. This study was performed to determine the safety of BLR and its optimal phase II dose. Patients with NHL or HL failing standard therapies received B (90 mg/m(2)  days 1, 2 every 28 days), and L (escalating from 5 mg 21/28 days) for six cycles, followed by 6 months of L. At the highest dose R 375 mg/m(2) on day one of each cycle was added for patients with B-NHL. Histologies included diffuse large B-cell lymphoma (DLBCL, 11), marginal zone lymphoma (3), HL (2), and one each of transformed follicular lymphoma, Sézary syndrome, Waldenström macroglobulinaemia and mantle cell lymphoma. Neutropenia was the most common grade 3 and 4 toxicity, but no maximum tolerated dose was identified. Of 20 patients, seven responded (35%), including four complete remissions, with five unmaintained responses from 28+ to 37+ months, including 2 DLBCL. BR with 20 mg l at, 21/28 days achieved durable responses; however, in light of its modest activity, and the availability of newer targeted therapies, the future of BLR is uncertain.

摘要

许多非霍奇金淋巴瘤(NHL)或霍奇金淋巴瘤(HL)患者会复发或对初始治疗耐药,需要更多治疗选择。苯达莫司汀(B)、来那度胺(L)和利妥昔单抗(R)在此种情况下均有活性。本研究旨在确定BLR方案的安全性及其最佳II期剂量。标准治疗失败的NHL或HL患者接受B(90mg/m²,第1、2天,每28天一次)和L(从5mg开始,21/28天递增),共六个周期,随后接受6个月的L治疗。对于B-NHL患者,在每个周期的第1天添加最高剂量为375mg/m²的R。组织学类型包括弥漫性大B细胞淋巴瘤(DLBCL,11例)、边缘区淋巴瘤(3例)、HL(2例),以及转化滤泡性淋巴瘤、塞扎里综合征、华氏巨球蛋白血症和套细胞淋巴瘤各1例。中性粒细胞减少是最常见的3级和4级毒性反应,但未确定最大耐受剂量。20例患者中,7例有反应(35%),包括4例完全缓解,5例未维持反应持续28 +至37 +个月,其中包括2例DLBCL。20mg l at,21/28天的BR方案取得了持久反应;然而,鉴于其活性一般,且有更新的靶向治疗药物可用,BLR方案的前景尚不确定。

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