Park Sung-Soo, Eom Hyeon-Seok, Kim Jin Seok, Koh Youngil, Choi Chul Won, Lee Je-Jung, Kim Kihyun, Suh Cheolwon, Lee Jae Hoon, Min Chang-Ki
Department of Hematology, Seoul St. Mary's Hematology Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Leukemia Research Institute, The Catholic University of Korea, Seoul, Korea.
Jpn J Clin Oncol. 2019 Jan 1;49(1):92-95. doi: 10.1093/jjco/hyy177.
Despite the recently reported efficacy of daratumumab monotherapy for patients with relapsed or refractory multiple myeloma, outcomes in real practice following daratumumab monotherapy have yet to be investigated. A multi-center retrospective study of 16 Korean patients receiving daratumumab monotherapy for relapsed or refractory multiple myeloma was conducted. The overall response rate was 56.3%. Three patients with creatinine clearance <30 ml/min even achieved an overall response. The median progression-free survival was 2.7 months with 28.9% (95% CI, 9.0-52.8) of 6-month progression-free survival. All infusion-related reactions, including ≥Grade 3 back pain (6.3%) and dyspnea (6.3%), were manageable. The most common hematologic and non-hematological adverse events were anemia (62.5%) and upper respiratory infection (43.8%). ≥Grade 3 bacterial infectious adverse events were identified, including upper and lower respiratory infection (12.5% and 18.8%) and death following sepsis (6.3%). We observed acceptable outcomes of daratumumab monotherapy on relapsed or refractory multiple myeloma patients including even a few subjects with high comorbidity, despite relatively frequent infectious adverse events.
尽管近期有报道称达雷妥尤单抗单药治疗对复发或难治性多发性骨髓瘤患者有效，但达雷妥尤单抗单药治疗后的实际疗效尚未得到研究。我们开展了一项多中心回顾性研究，纳入了16例接受达雷妥尤单抗单药治疗的复发或难治性多发性骨髓瘤韩国患者。总体缓解率为56.3%。3例肌酐清除率<30 ml/min的患者甚至实现了总体缓解。中位无进展生存期为2.7个月，6个月无进展生存率为28.9%（95%CI，9.0-52.8）。所有输液相关反应，包括≥3级背痛（6.3%）和呼吸困难（6.3%），均可控。最常见的血液学和非血液学不良事件分别为贫血（62.5%）和上呼吸道感染（43.8%）。确定了≥3级细菌感染性不良事件，包括上、下呼吸道感染（分别为12.5%和18.8%）以及败血症后死亡（6.3%）。我们观察到达雷妥尤单抗单药治疗复发或难治性多发性骨髓瘤患者的疗效尚可，即使是一些合并症较多的患者，尽管感染性不良事件相对频繁。
