Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression
Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression
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DOI：
10.1182/blood-2014-09-598763
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发表时间：
2015-02-26
期刊：
影响因子：
20.3
通讯作者：
Bartlett, Nancy L.
中科院分区：
文献类型：
--
作者：
Jacobsen, Eric D.;Sharman, Jeff P.;Bartlett, Nancy L.
几种非霍奇金淋巴瘤（NHL）亚型，包括弥漫性大B细胞淋巴瘤（DLBCL），均表达CD 30。这项II期、开放标签研究评价了维布妥昔单抗（一种抗CD 30抗体-药物偶联物）在复发性/难治性CD 30（+）NHL中的疗效。这项计划的B细胞NHL亚组分析包括49例DLBCL患者和19例其他B细胞NHL患者。DLBCL的客观缓解率为44%，包括8例（17%）完全缓解（CR），迄今为止的中位持续时间为16.6个月（范围：2.7至22.7+个月）。缓解与CD 30表达水平之间无统计学相关性;然而，通过计算机辅助免疫组织化学评估，所有缓解患者均具有可定量的CD 30。DLBCL患者通常对一线（76%）和最近的治疗（82%）难治，这些难治性患者中有44%有反应（15% CR）。其他B细胞淋巴瘤患者也有反应：1例CR，2例部分反应（PR），6例灰区，1例CR，6例原发性纵隔B细胞，1例CR，3例移植后淋巴增生性疾病。不良事件与已知毒性一致。维布妥昔单抗与利妥昔单抗联合给药通常耐受性良好，活性与维布妥昔单抗单药相似。总体而言，在复发性/难治性DLBCL中观察到维布妥昔单抗的显著活性，并且在CD 30表达范围内均发生缓解。本研究在www.clinicaltrials.gov注册为#NCT01421667。
Several non-Hodgkinlymphoma (NHL) subtypes, including diffuse large B-cell lymphoma (DLBCL), variably express CD30. This phase 2, open-label study evaluated the efficacy of brentuximab vedotin, an anti-CD30 antibody-drug conjugate, in relapsed/refractory CD30(+) NHL. This planned subset analysis of B-cell NHLs includes 49 patients with DLBCL and 19 with other B-cell NHLs. Objective response rate was 44% for DLBCL, including 8 (17%) complete remissions (CRs) with a median duration of 16.6 months thus far (range, 2.7 to 22.7+ months). There was no statistical correlation between response and level of CD30 expression; however, all responding patients had quantifiable CD30 by computer assisted assessment of immunohistochemistry. DLBCL patients were generally refractory to first-line (76%) and most recent therapies (82%), and 44% of these refractory patients responded (15% CRs). Patients with other B-cell lymphomas also responded: 1 CR, 2 partial responses (PRs) of 6 with gray zone, 1 CR of 6 with primary mediastinal B-cell, and 1 CR of 3 with posttransplant lymphoproliferative disorder. Adverse events were consistent with known toxicities. The combination of brentuximab vedotin with rituximab was generally well tolerated and had activity similar to brentuximab vedotin alone. Overall, significant activity with brentuximab vedotin was observed in relapsed/refractory DLBCL, and responses occurred across a range of CD30 expression. This study was registered at www.clinicaltrials.gov as #NCT01421667.