Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma
Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma
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DOI：
10.1182/blood-2016-02-699850
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发表时间：
2016-09-22
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：
Chen, Robert;Gopal, Ajay K.;Younes, Anas
这里介绍的是 brentuximab vedotin 在造血自体干细胞移植失败后复发/难治性 (R/R) 霍奇金淋巴瘤 (HL) 患者中进行的关键 2 期试验的 5 年研究结束结果。 5 年时，总体患者群体 (N = 102) 的估计总生存 (OS) 率为 41%（95% 置信区间 [CI]：31-51），无进展生存 (PFS) 率为 22%（95% CI：13-31）。对 brentuximab vedotin 实现完全缓解 (CR) 的患者 (N = 34) 估计 OS 和 PFS 率分别为 64% (95% CI: 48-80%) 和 52% (95% CI: 34-69%)。 CR 患者尚未达到中位 OS 和 PFS，其中 13 名患者（占所有 CR 患者的 38%）仍在随访中，并在研究结束时处于缓解状态。在 13 名患者中，4 名接受了巩固性造血同种异体干细胞移植，9 名（占所有入组患者的 9%）在使用 brentuximab vedotin 治疗后未接受任何进一步的抗癌治疗，仍保持持续 CR。在经历治疗引起的周围神经病变的患者中，88% 的症状得到缓解 (73%) 或改善 (14%)。这些 5 年随访数据表明，部分 R/R HL 患者通过单药 brentuximab vedotin 获得 CR，实现了长期疾病控制，并有可能治愈。该试验在 www.clinicaltrials.gov 上注册为#NCT00848926。
Presented here are the 5-year end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) after failed hematopoietic autologous stem cell transplantation. At 5 years, the overall patient population (N = 102) had an estimated overall survival (OS) rate of 41% (95% confidence interval [CI]: 31-51) and progression-free survival (PFS) rate of 22% (95% CI: 13-31). Patients who achieved a complete response (CR) to brentuximab vedotin (N = 34) had estimated OS and PFS rates of 64% (95% CI: 48-80%) and 52% (95% CI: 34-69%), respectively. The median OS and PFS were not reached in CR patients, with 13 patients (38% of all CR patients) remaining in follow-up and in remission at study closure. Of the 13 patients, 4 received consolidative hematopoietic allogeneic stem cell transplant, and 9 (9% of all enrolled patients) remain in sustained CR without receiving any further anticancer therapy after treatment with brentuximab vedotin. Of the patients who experienced treatment-emergent peripheral neuropathy, 88% experienced either resolution (73%) or improvement (14%) in symptoms. These 5-year follow-up data demonstrate that a subset of patients with R/R HL who obtained CR with single-agent brentuximab vedotin achieved long-term disease control and may potentially be cured. The trial was registered at www.clinicaltrials.gov as #NCT00848926.