Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies.
Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies.
复制标题
DOI：
10.1186/1756-8722-7-24
复制
发表时间：
2014-03-19
影响因子：
28.5
通讯作者：
Forero-Torres A
中科院分区：
文献类型：
--
作者：
Bartlett NL;Chen R;Fanale MA;Brice P;Gopal A;Smith SE;Advani R;Matous JV;Ramchandren R;Rosenblatt JD;Huebner D;Levine P;Grove L;Forero-Torres A
维布妥昔单抗是一种针对CD 30的抗体-药物偶联物。在先前的一项研究（ClinicalTrials.gov NCT 00947856）中，在接受初始维布妥昔单抗治疗后达到完全或部分缓解（CR或PR）后复发的CD 30阳性霍奇金淋巴瘤（HL）或系统性间变性大细胞淋巴瘤（ALCL）患者中研究了维布妥昔单抗单药治疗的再治疗。21例HL患者和8例系统性ALCL患者接受了再治疗; 3例系统性ALCL患者接受了两次再治疗。患者通常接受维布妥昔单抗1.8 mg/kg静脉输注，约每3周一次，持续30分钟，作为门诊输注。本研究的主要目的是评估维布妥昔单抗重新开始治疗的安全性并估计其抗肿瘤活性。HL患者的客观缓解率为60%（30% CR），系统性ALCL患者的客观缓解率为88%（63% CR）。研究结束时，客观缓解患者的估计中位缓解持续时间为9.5个月（范围：0.0+至28.0+个月）。在19例达到客观缓解的患者中，7例患者在研究结束时未发生疾病进展或死亡事件;这些患者的缓解持续时间范围为3.5 - 28个月。在11例CR患者中，45%的缓解持续时间超过1年。重新开始治疗期间≥25%患者发生的不良事件（AE）的类型和频率与维布妥昔单抗单药治疗关键性试验中观察到的不良事件的类型和频率基本相似，但周围神经病变除外，已知其具有累积效应。在48%的患者中观察到3级或以上事件;这些事件通常是一过性的，通过剂量调整或延迟进行管理。3例HL患者因AE死亡;认为均与维布妥昔单抗重新开始治疗无关。除了周围运动神经病变的发生率较高外，维布妥昔单抗重新治疗与关键试验中观察到的相似副作用相关。维布妥昔单抗单药重新治疗与68%（39% CR）复发性HL和系统性ALCL患者的缓解率相关。美国登记和结果数据库ClinicalTrials.gov NCT 00947856。
Brentuximab vedotin is a CD30-directed antibody-drug conjugate. Retreatment with brentuximab vedotin monotherapy was investigated in patients with CD30-positive Hodgkin lymphoma (HL) or systemic anaplastic large cell lymphoma (ALCL) who relapsed after achieving complete or partial remission (CR or PR) with initial brentuximab vedotin therapy in a previous study (ClinicalTrials.gov NCT00947856). Twenty-one patients with HL and 8 patients with systemic ALCL were retreated; 3 patients with systemic ALCL were retreated twice. Patients generally received brentuximab vedotin 1.8 mg/kg intravenously approximately every 3 weeks over 30 minutes as an outpatient infusion. The primary objectives of this study were to assess safety and to estimate antitumor activity of brentuximab vedotin retreatment. The objective response rate was 60% (30% CR) in HL patients and 88% (63% CR) in systemic ALCL patients. The estimated median duration of response for patients with an objective response was 9.5 months (range, 0.0+ to 28.0+ months) at the time of study closure. Of the 19 patients with objective response, 7 patients had not had an event of disease progression or death at the time of study closure; duration of response for these patients ranged from 3.5 to 28 months. Of the 11 patients with CR, 45% had response durations of over 1 year. Adverse events (AEs) occurring in ≥25% of patients during the retreatment period were generally similar in type and frequency to those observed in the pivotal trials of brentuximab vedotin monotherapy, with the exception of peripheral neuropathy, which is known to have a cumulative effect. Grade 3 or higher events were observed in 48% of patients; these were generally transient and managed by dose modifications or delays. Deaths due to AEs occurred in 3 HL patients; none were considered to be related to brentuximab vedotin retreatment. With the exception of a higher rate of peripheral motor neuropathy, retreatment with brentuximab vedotin was associated with similar side effects seen in the pivotal trials. Retreatment with brentuximab vedotin monotherapy is associated with response rates in 68% (39% CR) of patients with relapsed HL and systemic ALCL. United States registry and results database ClinicalTrials.gov NCT00947856.
登录
查看更多内容
影响因子：
10.1
作者：
Gibb, Adam;Jones, Craig;Radford, John
通讯作者：
Radford, John
影响因子：
45.3
作者：
Pro, Barbara;Advani, Ranjana;Shustov, Andrei
通讯作者：
Shustov, Andrei
影响因子：
45.3
作者：
Davis, TA;Grillo-López, AJ;Levy, R
通讯作者：
Levy, R
影响因子：
10.1
作者：
Schmitz, Norbert;Dreger, Peter;Sureda, Anna
通讯作者：
Sureda, Anna
影响因子：
45.3
作者：
Younes, Anas;Gopal, Ajay K.;Chen, Robert
通讯作者：
Chen, Robert