二线博来霉素+本妥昔单抗治疗后自体干细胞移植治疗复发或难治性霍奇金淋巴瘤。
Autologous stem-cell transplantation after second-line brentuximab vedotin in relapsed or refractory Hodgkin lymphoma.
机构信息
Department of Hematology and Hematopoietic Cell Transplantation, Division of Biostatistics, City of Hope, Duarte, USA.
Department of Information Sciences, Division of Biostatistics, City of Hope, Duarte, USA.
出版信息
Ann Oncol. 2018 Mar 1;29(3):724-730. doi: 10.1093/annonc/mdx791.
BACKGROUND
We previously demonstrated that brentuximab vedotin (BV) used as second-line therapy in patients with Hodgkin lymphoma is a tolerable and effective bridge to autologous hematopoietic cell transplantation (AHCT). Here, we report the post-AHCT outcomes of patients treated with second-line standard/fixed-dose BV and an additional cohort of patients where positron-emission tomography adapted dose-escalation of second-line BV was utilized.
PATIENTS AND METHODS
Patients on the dose-escalation cohort received 1.8 mg/kg of BV intravenously every 3 weeks for two cycles. Patients in complete remission (CR) after two cycles received two additional cycles of BV at 1.8 mg/kg, while patients with stable disease or partial response were escalated to 2.4 mg/kg for two cycles. All patients, regardless of treatment cohort, proceeded directly to AHCT or received additional pre-AHCT therapy at the discretion of the treating physician based on remission status after second-line BV.
RESULTS
Of the 20 patients enrolled to the BV dose-escalation cohort, 8 patients underwent BV dose-escalation. BV escalation was well-tolerated, but no patients who were escalated converted to CR. Of 56 evaluable patients treated across cohorts, the overall response rate (ORR) to second-line BV was 75% with 43% CR. Twenty-eight (50%) patients proceeded directly to AHCT without post-BV chemotherapy, and a total of 50 patients proceeded to AHCT. Thirteen patients received consolidative post-AHCT therapy with either radiation, BV, or a PD-1 inhibitor. After AHCT, the 2-year progression-free survival (PFS) and overall survival were 67% and 93%, respectively. The 2-year PFS among patients in CR at the time of AHCT (n = 37) was 71% compared with 54% in patients not in CR (p = 0.12). The 2-year PFS in patients who proceeded to AHCT directly after receiving BV alone was 77%.
CONCLUSIONS
Second-line BV is an effective bridge to AHCT that produces responses of sufficient depth to provide durable remission in conjunction with AHCT (clinicaltrials.gov: NCT01393717).
背景
我们之前的研究表明，博纳吐单抗（BV）作为霍奇金淋巴瘤二线治疗药物，与自体造血细胞移植（AHCT）联合使用是一种可耐受且有效的桥接治疗。在此，我们报告了二线标准/固定剂量 BV 治疗后接受 AHCT 的患者的结果，以及另一组接受二线 BV 基于正电子发射断层扫描（PET）的剂量递增的患者的结果。
患者和方法
剂量递增组的患者每 3 周静脉注射 1.8mg/kg 的 BV，共 2 个周期。两个周期后达到完全缓解（CR）的患者接受另外两个周期 1.8mg/kg 的 BV，而病情稳定或部分缓解的患者则增加到两个周期的 2.4mg/kg。所有患者，无论治疗组如何，根据二线 BV 后缓解情况直接进行 AHCT或由主治医生根据需要接受额外的 AHCT 前治疗。
结果
20 例入组 BV 剂量递增组的患者中，有 8 例进行了 BV 剂量递增。BV 剂量递增耐受良好，但没有患者的缓解程度达到 CR。在接受二线 BV 治疗的 56 例可评估患者中，总体缓解率（ORR）为 75%，其中 43%为 CR。28 例（50%）患者在没有接受二线 BV 后化疗的情况下直接进行 AHCT，共 50 例患者进行了 AHCT。13 例患者接受了巩固性 AHCT 治疗，包括放疗、BV 或 PD-1 抑制剂。AHCT 后，2 年无进展生存率（PFS）和总生存率分别为 67%和 93%。在 AHCT 时达到 CR 的患者（n=37）2 年 PFS 为 71%，而未达到 CR 的患者（n=19）为 54%（p=0.12）。直接接受单独 BV 治疗后进行 AHCT 的患者的 2 年 PFS 为 77%。
结论
二线 BV 是 AHCT 的有效桥接治疗药物，与 AHCT 联合使用可产生足够深度的缓解，从而在结合 AHCT 的情况下提供持久的缓解（clinicaltrials.gov：NCT01393717）。
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