Interim results of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma
Interim results of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma
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DOI：
10.1182/blood-2017-10-811224
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发表时间：
2018-03-15
期刊：
影响因子：
20.3
通讯作者：
Advani, Ranjana H.
中科院分区：
文献类型：
--
作者：
Herrera, Alex F.;Moskowitz, Alison J.;Advani, Ranjana H.
在这项1/2期研究中，brentuximab vedotin （BV）和nivolumab （Nivo）联合使用作为复发或难治性（R/R）经典霍奇金淋巴瘤（HL）患者的初始挽救治疗进行了评估。患者接受了长达4个周期的联合治疗，在第一个周期的第1天给予BV，在第8天给予Nivo。周期2至4，BV和Nivo均在第1天给予。研究治疗后，研究人员根据2014年Lugano分类评估反应，患者可以进行自体干细胞移植（ASCT）。共纳入62例患者；所有治疗患者（n=61）的完全缓解率为61%，客观缓解率为82%。在ASCT之前，98%的患者发生不良事件（ae），主要是1级和2级。44%的患者发生了输注相关反应（IRRs），其中41%的患者在至少1次BV输注期间发生了IRR。5名患者（8%）接受了系统性类固醇治疗免疫相关不良反应。首次注射BV后，观察到包括调节性T细胞在内的外周血T细胞亚群减少，首次注射BV加Nivo后，血清胸腺和激活调节趋化因子水平降低，促炎细胞因子和趋化因子水平升高。BV联合Nivo是一种积极且耐受性良好的第一挽救方案，可能为R/R HL患者提供传统化疗的替代方案。
In this phase 1/2 study, brentuximab vedotin (BV) and nivolumab (Nivo) administered in combination were evaluated as initial salvage therapy in patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (HL). Patients received up to 4 cycles of combination treatment, with BV administered on day 1 and Nivo on day 8 of the first cycle. For cycles 2 to 4, BV and Nivo were both administered on day 1. After study treatment, responses were evaluated by investigators per the 2014 Lugano classification, and patients could proceed to autologous stem cell transplantation (ASCT). Sixty-two patients were enrolled; the complete response rate among all treated patients (n=61) was 61%, with an objective response rate of 82%. Before ASCT, adverse events (AEs) occurred in 98% of patients, mostly grades 1 and 2. Infusion-related reactions (IRRs) occurred in 44% of patients overall, with 41% of patients experiencing an IRR during at least 1 infusion of BV. Five patients (8%) were treated with systemic steroids for immune-related AEs. A reduction of peripheral T-cell subsets including regulatory T cells was observed after the first dose of BV, and reduced serum levels of thymus- and activation-regulated chemokine concurrent with an increase in proinflammatory cytokines and chemokines were seen after the first BV plus Nivo infusions. The combination of BV plus Nivo was an active and well-tolerated first salvage regimen, potentially providing patients with R/R HL an alternative to traditional chemotherapy.