Gemtuzumab ozogamicin (Mylotarg®) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia:: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups
Gemtuzumab ozogamicin (Mylotarg®) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia:: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups
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DOI：
10.1038/sj.leu.2403901
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发表时间：
2005-10-01
期刊：
影响因子：
11.4
通讯作者：
de Witte, T
中科院分区：
文献类型：
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作者：
Amadori, S;Suciu, S;de Witte, T
在40例年龄460岁的急性髓性白血病（AML）患者中评估了吉妥珠单抗的治疗活性和毒性特征，这些患者因高龄或体力状态差而被认为不适合常规化疗。在第1天和第15天以9 mg/m2的剂量单次静脉输注2小时。达到完全缓解（CR/CRp）的患者将接受两次相同剂量免疫毒素额外注射的巩固治疗。总体CR/CRp率为17%（95% CI，8-32%）。61-75岁患者的CR/CRp率为33%（6/18），75岁以上患者的CR/CRp率为5%（1/22）。7例患者（17%）发生诱导期死亡，年龄均在75岁以上。61-75岁患者的总生存期显著长于老年患者（P = 0.05），CD 33+患者的总生存期显著长于CD 33-患者（P = 0.05）。我们得出结论，本试验中使用的吉妥珠单抗奥佐米星剂量/方案在75岁以上年龄组中毒性太大。对于这些患者，需要进行减少免疫毒素剂量的额外研究。
The therapeutic activity and toxicity profile of gemtuzumab ozogamicin were assessed in 40 patients 460 years of age with acute myeloid leukemia (AML) who were not considered eligible for conventional chemotherapy because of advanced age or poor performance status. The drug was administered at the dose of 9mg/m(2) as a single 2-h i.v. infusion on days 1 and 15. Patients who achieved a complete remission (CR/CRp) were to receive a consolidation with two additional injections of the immunotoxin at the same dose. The overall CR/CRp rate was 17% (95% CI, 8-32%). The CR/CRp rate in patients 61-75 years old was 33% (6/18), and 5% (1/22) in patients older than 75 years. Induction death occurred in seven patients (17%), all aged above 75 years. Overall survival was significantly longer in patients aged 61-75 years than in older individuals (P = 0.05), and in CD33+ cases than in CD33- cases (P = 0.05). We conclude that the dose/schedule of gemtuzumab ozogamicin used in this trial is too toxic in the age group over 75 years. For these patients, additional studies with reduced doses of the immunotoxin are warranted.