Giles Francis, Estey Elihu, O'Brien Susan
Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA.
Cancer. 2003 Nov 15;98(10):2095-104. doi: 10.1002/cncr.11791.
Gemtuzumab ozogamicin (GO) is a chemotherapeutic agent that consists of a humanized anti-CD33 antibody (hP67.6) linked to N-acetyl-gamma calicheamicin 1,2-dimethyl hydrazine dichloride, a potent enediyne antitumor antibiotic. GO was approved conditionally by the Federal Drug Administration in May 2000 as single-agent therapy for first recurrence of acute myeloid leukemia (AML) in a subset of older patients. Data on studies in AML with GO-based regimens have been reported rapidly in addition to new observations on the target antigen, CD33. These data indicate promising new areas of investigation with GO, including its application as maintenance therapy in patients with AML and as an induction and/or maintenance agent in patients with acute promyelocytic leukemia;, and they also have highlighted challenges in the development of GO, particularly its association with hepatic venoocclusive disease. In vitro data on the mechanism of action of GO may be particularly helpful in the design of future clinical studies.
吉妥单抗奥唑米星（GO）是一种化疗药物，它由一种人源化抗CD33抗体（hP67.6）与N - 乙酰 - γ - 加利车霉素1,2 - 二甲基肼二氯化物连接而成，后者是一种强效的烯二炔类抗肿瘤抗生素。2000年5月，GO被美国食品药品监督管理局有条件批准，作为老年患者亚组中急性髓系白血病（AML）首次复发的单药治疗。除了关于靶抗原CD33的新观察结果外，基于GO方案治疗AML的研究数据也迅速得到了报道。这些数据表明GO有前景广阔的新研究领域，包括其作为AML患者维持治疗以及急性早幼粒细胞白血病患者诱导和/或维持治疗药物的应用；它们还凸显了GO开发过程中的挑战，尤其是其与肝静脉闭塞性疾病的关联。关于GO作用机制的体外数据可能对未来临床研究的设计特别有帮助。
