Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma: Results of a Phase II Study
Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma: Results of a Phase II Study
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DOI：
10.1200/jco.2011.38.0402
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发表时间：
2012-06-20
影响因子：
45.3
通讯作者：
Shustov, Andrei
中科院分区：
文献类型：
--
作者：
Pro, Barbara;Advani, Ranjana;Shustov, Andrei
目的系统性间变性大细胞淋巴瘤(ALCL)是T细胞淋巴瘤的一种侵袭性亚型，以CD30均匀表达为特征。抗体-药物结合物布妥昔单抗维多丁为CD30阳性的恶性肿瘤细胞提供了有效的抗微管剂单甲基尿素E。采用II期多中心临床试验评价布妥昔单抗维多丁治疗复发性或难治性系统性ALCL的疗效和安全性。患者和方法系统性ALCL患者在至少一次治疗后，每3周静脉滴注布妥昔单抗维多丁1.8 mg/kg，30分钟为门诊输液。结果在接受研究的58例患者中，50例(86%)达到客观缓解，33例(57%)达到完全缓解(CR)，17例(29%)达到部分缓解。中位有效和完全缓解时间分别为12.6个月和13.2个月。10%的患者出现3级或4级不良反应，包括中性粒细胞减少症(21%)、血小板减少症(14%)和周围感觉神经病(12%)。结论布妥昔单抗维多丁在大多数复发全身性ALCL患者中引起客观反应，在一半以上的复发全身性ALCL患者中出现CRS。这种CD30导向的抗体-药物结合物的靶向治疗对于复发或难治性系统性ALCL可能是一种有效的治疗方法，值得在一线治疗方面进行进一步研究。J Clin Oncol30：2190-2196。(C)2012年美国临床肿瘤学会
PurposeSystemic anaplastic large-cell lymphoma (ALCL) is an aggressive subtype of T-cell lymphoma characterized by the uniform expression of CD30. The antibody-drug conjugate brentuximab vedotin delivers the potent antimicrotubule agent monomethylauristatin E to CD30-positive malignant cells. A phase II multicenter trial was conducted to evaluate the efficacy and safety of brentuximab vedotin in patients with relapsed or refractory systemic ALCL.Patients and MethodsPatients with systemic ALCL and recurrent disease after at least one prior therapy received brentuximab vedotin 1.8 mg/kg intravenously every 3 weeks over 30 minutes as an outpatient infusion. The primary end point of the study was overall objective response rate as assessed by independent central review.ResultsOf 58 patients treated in the study, 50 patients (86%) achieved an objective response, 33 patients (57%) achieved a complete remission (CR), and 17 patients (29%) achieved a partial remission. The median durations of overall response and CR were 12.6 and 13.2 months, respectively. Grade 3 or 4 adverse events in >= 10% of patients were neutropenia (21%), thrombocytopenia (14%), and peripheral sensory neuropathy (12%).ConclusionBrentuximab vedotin induced objective responses in the majority of patients and CRs in more than half of patients with recurrent systemic ALCL. Targeted therapy with this CD30-directed antibody-drug conjugate may be an effective treatment for relapsed or refractory systemic ALCL and warrants further studies in front-line therapy. J Clin Oncol 30:2190-2196. (c) 2012 by American Society of Clinical Oncology