Department I of Internal Medicine and German Hodgkin Study Group (GHSG), University Hospital of Cologne, Cologne, Germany.
Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Eur J Haematol. 2017 Dec;99(6):553-558. doi: 10.1111/ejh.12973. Epub 2017 Oct 16.
Brentuximab vedotin (BV) is an anti-CD30 antibody-drug conjugate licensed for the treatment of relapsed/refractory Hodgkin lymphoma (rrHL) following autologous stem cell transplant (ASCT) or at least two prior therapies when ASCT or multiagent chemotherapy is not an option. The objective of this study was to describe real-world outcomes with BV in patients with rrHL considered ASCT ineligible or who refuse ASCT.
This was a retrospective medical chart review study that enrolled patients ≥18 years old who were initially diagnosed with HL between January 1, 2008 and June 30, 2014, considered ASCT ineligible, and treated in routine care with BV for progressive disease after multidrug chemotherapy regimens. Clinical outcomes included best response to treatment, progression-free survival (PFS), overall survival (OS), and adverse events.
A total of 136 patients were included, with a median age of 70 years at initial HL diagnosis. The most common reasons for ASCT ineligibility were comorbidities (74%) and age (57%). Overall response rate was 74%, and PFS and OS were 15.1 and 17.8 months, respectively. Peripheral neuropathy was observed in 9.6% of patients.
The results of this study provide real-world evidence on the feasibility and effectiveness of BV in elderly or frail ASCT-ineligible patients with rrHL in a real-world setting.
本研究旨在描述在不符合自体干细胞移植（ASCT）条件或拒绝 ASCT 的复发/难治性霍奇金淋巴瘤（rrHL）患者中，应用 Brentuximab vedotin（BV）的真实世界疗效。BV 是一种抗 CD30 抗体药物偶联物，获批用于 ASCT 后或至少接受过两种前期治疗（当 ASCT 或多药化疗不是选择时）的 rrHL 治疗。
这是一项回顾性病历审查研究，纳入了 2008 年 1 月 1 日至 2014 年 6 月 30 日期间初始诊断为 HL 的年龄≥18 岁患者，这些患者被认为不符合 ASCT 条件，并在多药化疗方案后疾病进展时，接受常规护理中应用 BV 治疗。临床结局包括最佳治疗反应、无进展生存期（PFS）、总生存期（OS）和不良事件。
共纳入了 136 例患者，在初始 HL 诊断时的中位年龄为 70 岁。不符合 ASCT 的最常见原因是合并症（74%）和年龄（57%）。总体缓解率为 74%，PFS 和 OS 分别为 15.1 和 17.8 个月。9.6%的患者出现周围神经病。
这项研究结果提供了在真实世界环境中，对于不适合接受 ASCT 的老年或体弱 rrHL 患者，应用 BV 的可行性和有效性的真实世界证据。
