Department of Hematology and Oncology, University of Fukui, 23-3, Shimoaizuki, Fukui, Matsuoka, 910-1193, Japan.
Int J Hematol. 2021 Mar;113(3):362-369. doi: 10.1007/s12185-020-03023-4. Epub 2020 Nov 20.
We retrospectively evaluated the clinical efficacy and toxicity of gemtuzumab ozogamicin (GO) in patients with relapsed acute myeloid leukemia (AML). Nineteen patients (median 70 years) received GO (9 mg/m, days 1 and 15) as salvage therapy in our institution between 2006 and 2017. The primary endpoint was the response rate. The secondary endpoint was the occurrence of adverse events. Thirteen patients had de novo AML, and 6 patients had secondary AML. Most of the patients had received salvage treatments more than once prior to GO. Six patients responded to the treatment (31.6%) with 3 complete remissions (15.8%). Five patients had stable disease, and 8 patients did not show any response. GO was more efficacious among the patients with fewer numbers of prior salvage treatments. CD33 positivity of leukemic cells was higher in responders than in nonresponders. Peripheral WT1 mRNA levels mostly decreased over time in the responders. The adverse event most commonly seen was febrile neutropenia (84%). No patient presented with veno-occlusive disease. Three patients died by day 30 (mortality rate 15.8%), one due to acute respiratory distress syndrome and the other two due to sepsis. GO remains an effective salvage treatment.
我们回顾性评估了吉妥珠单抗奥佐米星（GO）在复发性急性髓系白血病（AML）患者中的临床疗效和毒性。2006 年至 2017 年期间，19 例（中位年龄 70 岁）患者在我院接受 GO（9mg/m，第 1 天和第 15 天）作为挽救性治疗。主要终点是反应率。次要终点是不良事件的发生。13 例患者为初发性 AML，6 例患者为继发性 AML。大多数患者在接受 GO 治疗前已接受过多次挽救性治疗。6 例患者对治疗有反应（31.6%），其中 3 例完全缓解（15.8%）。5 例患者病情稳定，8 例患者无反应。GO 在接受较少次数挽救性治疗的患者中更有效。GO 对白血病细胞 CD33 阳性的患者更有效。GO 治疗后，反应者外周血 WT1 mRNA 水平大多随时间下降。最常见的不良反应是发热性中性粒细胞减少症（84%）。无患者出现静脉阻塞性疾病。3 例患者在第 30 天死亡（死亡率 15.8%），1 例死于急性呼吸窘迫综合征，另 2 例死于败血症。GO 仍然是一种有效的挽救性治疗方法。
