Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma
Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma
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DOI：
10.1182/blood-2014-08-595801
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发表时间：
2015-02-19
期刊：
影响因子：
20.3
通讯作者：
Younes, Anas
中科院分区：
文献类型：
--
作者：
Gopal, Ajay K.;Chen, Robert;Younes, Anas
我们介绍了一项在自体干细胞移植后复发性/难治性霍奇金淋巴瘤患者（N = 102）中进行的抗体-药物偶联物维布妥昔单抗关键II期试验的缓解和生存结局，中位观察期约为3年。中位总生存期和无进展生存期估计分别为40.5个月和9.3个月。在维布妥昔单抗治疗后达到完全缓解（CR）的患者中观察到结局改善，该组的估计3年总生存期和无进展生存率分别为73%（95%置信区间[CI]：57%，88%）和58%（95% CI：41%，76%）（未达到中位数）。在获得CR的34例患者中，16例（47%）在中位观察期53.3个月（范围29.0 - 56.2个月）后保持无进展; 12例患者在未进行巩固性同种异体干细胞移植的情况下保持无进展。较年轻的年龄、良好的体能状态和基线时较低的疾病负担是达到CR的患者的特征，也是总生存期的有利预后因素。这些结果表明，维布妥昔单抗治疗应答的患者中有相当一部分可以实现长期疾病控制。
We present response and survival outcomes of a pivotal phase 2 trial of the antibody-drug conjugate brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant (N = 102) after a median observation period of approximately 3 years. Median overall survival and progression-free survival were estimated at 40.5 months and 9.3 months, respectively. Improved outcomes were observed in patients who achieved a complete remission (CR) on brentuximab vedotin, with estimated 3-year overall survival and progression-free survival rates of 73% (95% confidence interval [Cl]: 57%, 88%) and 58% (95% Cl: 41%, 76%), respectively, in this group (medians not reached). Of the 34 patients who obtained CR, 16 (47%) remain progression-free after a median of 53.3 months (range, 29.0 to 56.2 months) of observation; 12 patients remain progression-free without a consolidative allogeneic stem cell transplant. Younger age, good performance status, and lower disease burden at baseline were characteristic of patients who achieved a CR and were favorable prognostic factors for overall survival. These results suggest that a significant proportion of patients who respond to brentuximab vedotin can achieve prolonged disease control.