Fenton Caroline, Perry Caroline M
Adis International Limited, Auckland, New Zealand.
BioDrugs. 2006;20(2):137-9. doi: 10.2165/00063030-200620020-00007.
Gemtuzumab ozogamicin (Mylotarg) is a conjugate of a monoclonal antibody and calicheamicin, which targets the membrane antigen CD33 in CD33-positive acute myeloid leukaemia (AML) and, after cell internalization, releases a derivative of the cytotoxic calicheamicin component. In the US, it is approved as monotherapy in patients aged>or=60 years with a first relapse of AML who are ineligible for other cytotoxic therapy. Monotherapy with gemtuzumab ozogamicin results in complete remission (CR) or CR with incomplete platelet recovery (CRp) in approximate, equals 25% of adults (including those aged>or=60 years) with CD33-positive AML in first relapse. Preliminary data indicate a potential role for gemtuzumab ozogamicin as a component of induction or consolidation regimens in adults and, based on an early study, in the treatment of children with AML, although randomized, controlled studies are needed. Serious adverse events, notably hepatotoxicity, characterize its tolerability profile, but gemtuzumab ozogamicin is comparatively well tolerated by most patients. Gemtuzumab ozogamicin is a valuable new treatment option for patients aged>or=60 years with CD33-positive AML in first relapse for whom other cytotoxic chemotherapy is not considered appropriate; patients with a first CR (CR1) of >12 months are likely to have the best outcome.
吉妥单抗（Mylotarg）是一种单克隆抗体与卡奇霉素的偶联物，它靶向CD33阳性急性髓系白血病（AML）中的膜抗原CD33，在细胞内化后释放出细胞毒性卡奇霉素成分的衍生物。在美国，它被批准用于年龄≥60岁、首次复发且不适合其他细胞毒性疗法的AML患者的单药治疗。吉妥单抗单药治疗可使约25%的首次复发的CD33阳性AML成人患者（包括年龄≥60岁者）达到完全缓解（CR）或伴有血小板未完全恢复的CR（CRp）。初步数据表明，吉妥单抗在成人诱导或巩固治疗方案中可能发挥作用，并且根据一项早期研究，在儿童AML治疗中也可能有作用，不过仍需要随机对照研究。严重不良事件，尤其是肝毒性，是其耐受性方面的特征，但大多数患者对吉妥单抗的耐受性相对较好。对于年龄≥60岁、首次复发且不适合其他细胞毒性化疗的CD33阳性AML患者，吉妥单抗是一种有价值的新治疗选择；首次完全缓解（CR1）超过12个月的患者可能预后最佳。
