Department of Haematology, Royal North Shore Hospital, St. Leonards, Australia.
Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Leuk Lymphoma. 2020 Sep;61(9):2103-2112. doi: 10.1080/10428194.2020.1759055. Epub 2020 Jun 16.
The phase 2 portion of this open-label phase 2/3 study assessed the efficacy and safety of blinatumomab as second salvage for aggressive relapsed or refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (B-NHL) following platinum-based first salvage chemotherapy. Forty-one patients with aggressive disease (32% relapsed; 68% refractory) enrolled and received stepwise blinatumomab (9-28-112 μg/day) in a 70-day cycle 1 and an optional 28-day cycle 2; 19 (46%) completed cycle 1 and 3 (7%) completed cycle 2. The overall response rate after 12 weeks was 37%, including 9 (22%) complete metabolic responses. Eight (20%) patients (all responders) subsequently received stem cell transplants. Grade ≥3 adverse events were reported in 29 (71%) patients. Grade 3 cytokine release syndrome occurred in one patient. Grade 3 neurologic events occurred in 10 (24%) patients; all resolved. Blinatumomab monotherapy appears effective as second salvage therapy in patients with r/r aggressive B-NHL. NCT02910063.
本 2/3 期开放标签 2 期研究的 2 期部分评估了blinatumomab 作为二线挽救治疗用于接受基于铂类的一线挽救化疗后复发或难治性（r/r）侵袭性 B 细胞非霍奇金淋巴瘤（B-NHL）患者的疗效和安全性。41 名侵袭性疾病患者（32%复发；68%难治）入组并接受逐步blinatumomab（9-28-112μg/天）治疗，1 个 70 天周期和 1 个可选的 28 天周期 2；19 名（46%）完成周期 1，3 名（7%）完成周期 2。12 周后的总体缓解率为 37%，包括 9 名（22%）完全代谢缓解。随后，8 名（20%）患者（所有应答者）接受了干细胞移植。29 名（71%）患者报告了≥3 级不良事件。1 名患者发生 3 级细胞因子释放综合征。10 名（24%）患者发生 3 级神经事件；均已解决。blinatumomab 单药治疗似乎对 r/r 侵袭性 B-NHL 患者作为二线挽救治疗有效。NCT02910063。
