Efficacy of Brentuximab Vedotin in Relapsed or Refractory High-CD30-Expressing Non-Hodgkin Lymphomas: Results of a Multicenter, Open-Labeled Phase II Trial
Efficacy of Brentuximab Vedotin in Relapsed or Refractory High-CD30-Expressing Non-Hodgkin Lymphomas: Results of a Multicenter, Open-Labeled Phase II Trial
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DOI：
10.4143/crt.2019.198
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发表时间：
2020-04-01
影响因子：
4.6
通讯作者：
Kim, Won Seog
中科院分区：
文献类型：
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作者：
Kim, Seok Jin;Yoon, Dok Hyun;Kim, Won Seog
目的在以往的研究中，brentuximab vedotin （BV）的治疗结果与CD30表达水平无关。因此，本研究探讨了BV在高cd30表达的非霍奇金淋巴瘤（NHL）患者中最有可能受益的疗效。材料和方法该II期研究（Clinicaltrials.gov: NCT02280785）纳入复发或难治性高cd30表达的NHL患者，BV每3周静脉注射1.8 mg/kg。主要终点为40%的疾病控制率，包括完全缓解（CR）、部分缓解（PR）或疾病稳定。我们将CD30高表达定义为>= 30%的肿瘤细胞免疫组化CD30阳性。结果除间变性大细胞淋巴瘤外，共纳入高表达cd30的NHL患者33例。疾病控制率为48.5%(16/33)，其中CR 6例，PR 6例；6例患者（4CR, 2PR）在16个完整周期内保持疗效。对BV的反应和生存与CD30表达水平无关。在29.2个月的中位随访中，中位无进展生存率和总生存率分别为1.9个月和6.1个月。最常见的不良事件是发热（39%）、中性粒细胞减少（30%）、疲劳（24%）和周围感觉神经病变（27%）。在对多发性骨髓瘤癌基因1 （MUM1）与治疗结果相关性的事后分析中，MUM1阴性患者的反应（55.6%,5/9）高于MUM1阳性患者（13.3%,2/15）。结论bv单药在疾病控制率和毒性方面是可以接受的，特别是在mum1阴性患者。
PurposeThe treatment outcome of brentuximab vedotin (BV) has not been related with CD30 expression in previous studies enrolling patients with a wide range of CD30 expression level. Thus, this study explored the efficacy of BV in high-CD30-expressing non-Hodgkin lymphoma (NHL) patients most likely to benefit.Materials and MethodsThis phase II study (Clinicaltrials.gov: NCT02280785) enrolled relapsed or refractory high-CD30-expressing NHL with BV administered intravenously at 1.8 mg/kg every 3 weeks. The primary endpoint was > 40% disease control rate, consisting of complete response (CR), partial response (PR), or stable disease. We defined high CD30 expression as >= 30% tumor cells positive for CD30 by immunohistochemistry.ResultsHigh-CD30-expressing NHL patients (n=33) were enrolled except anaplastic large cell lymphoma. The disease control rate was 48.5% (16/33) including six CR and six PR; six patients (4CR, 2PR) maintained their response over 16 completed cycles. Response to BV and survival were not associated with CD30 expression levels. Over a median of 29.2 months of follow-up, the median progression-free and overall survival rates were 1.9 months and 6.1 months, respectively. The most common adverse events were fever (39%), neutropenia (30%), fatigue (24%), and peripheral sensory neuropathy (27%). In a post-hoc analysis for the association of multiple myeloma oncogene 1 (MUM1) on treatment outcome, MUM1-negative patients showed a higher response (55.6%, 5/9) than MUM1-positive patients (13.3%, 2/15).ConclusionBV performance as a single agent was acceptable in terms of disease control rates and toxicity profiles, especially MUM1-negative patients.