Ruutu T, Almqvist A, Hallman H, Honkanen T, Järvenpää E, Järventie G, Koistinen P, Koivunen E, Lahtinen R, Lehtinen M
Third Department of Medicine, Helsinki University Central Hospital, Finland.
Leukemia. 1994 Jan;8(1):11-5.
In order to study the efficacy of an oral induction and consolidation regimen in the treatment of acute myeloid leukemia (AML) in elderly patients assessed not to tolerate full-scale intensive chemotherapy, 51 patients over 65 years of age with newly diagnosed AML were randomized to receive two cycles of either totally oral ETI (25 patients) or conventional 5-day TAD (26 patients). The median age of the patients was 73 years, range 65-87 years. Thirty-eight patients had de novo AML and the remaining patients AML subsequent to myelodysplastic syndrome ((n = 11) or treatment related AML (n = 2)). ETI consisted of etoposide 80 mg/m2 and thioguanine 100 mg/m2 twice a day on days 1-5, and idarubicin 15 mg/m2 on days 1-3, all given orally. TAD consisted of oral thioguanine and i.v. cytarabine, both in the dose of 100 mg/m2 twice a day on days 1-5, and daunorubicin 60 mg/m2 on day 5. The maintenance treatment was daily oral mercaptopurine 70 mg/m2 and weekly oral methotrexate 12 mg/m2. In the ETI group complete remission (CR) was achieved in six patients after the first cycle and in nine more patients after the second cycle. The CR rate was 15/25 = 60%. The corresponding figures for the TAD group were four and two remissions, CR rate 6/26 = 23% (p = 0.007). The survival was significantly longer in the ETI arm (p = 0.042). The median survival was 9.9 months in the ETI group and 3.7 months in the TAD group. There were no significant differences in the side effects between the two arms. In conclusion, the totally oral ETI regimen resulted in a significantly higher remission rate and longer survival than the 5-day TAD regimen in elderly patients with AML, with no more toxicity.
为研究口服诱导和巩固方案对评估为无法耐受全面强化化疗的老年急性髓系白血病（AML）患者的疗效，将51例65岁以上新诊断为AML的患者随机分为两组，分别接受两个周期的全口服ETI方案（25例患者）或传统的5天TAD方案（26例患者）。患者的中位年龄为73岁，范围在65至87岁之间。38例患者为初发AML，其余患者为骨髓增生异常综合征后发生的AML（n = 11）或治疗相关AML（n = 2）。ETI方案包括第1 - 5天口服依托泊苷80 mg/m²和硫鸟嘌呤100 mg/m²，每日两次，第1 - 3天口服伊达比星15 mg/m²。TAD方案包括口服硫鸟嘌呤和静脉注射阿糖胞苷，剂量均为100 mg/m²，每日两次，第1 - 5天使用，第5天使用柔红霉素60 mg/m²。维持治疗为每日口服巯嘌呤70 mg/m²和每周口服甲氨蝶呤12 mg/m²。在ETI组中，6例患者在第一个周期后达到完全缓解（CR），另有9例患者在第二个周期后达到完全缓解。CR率为15/25 = 60%。TAD组相应的数据为4例和2例缓解，CR率为6/26 = 23%（p = 0.007）。ETI组的生存期明显更长（p = 0.042）。ETI组的中位生存期为9.9个月，TAD组为3.7个月。两组之间的副作用无显著差异。总之，对于老年AML患者，全口服ETI方案比5天TAD方案的缓解率显著更高，生存期更长，且毒性更小。
