Freigeiro D, Scaglione C, Santarelli M T, Sackmann Muriel F, Jiménez E, Pavlovsky S, Bustelo P, Richard L, Kohan R, Kvicala R
Sangre (Barc). 1989 Jun;34(3):221-8.
Three hundred and seventy-one children below 16 years, with newly diagnosed acute myeloid leukaemia, were included in six consecutive GATLA/GLATHEM protocols, from November 1967 to December 1987. The study was divided in three periods: 1967 to 1975, 1976 to 1982, and 1983 to 1987. Three induction schedules were used during the first two periods, and different maintenance schemes alternating with monthly consolidations were explored; the value of immunotherapy with C. Parvum and androgen therapy with stanozolol was also tested. Protocol 3-AML-83, representing the third period, included a four-week induction phase with vincristine, adriamycin, cytosine-arabinoside, prednisone and 6-mercaptopurine, followed by a consolidation phase with cyclophosphamide, cytosine-arabinoside and 6-mercaptopurine for four weeks. Maintenance phase included daily, oral 6-mercaptopurine, and monthly cytosine-arabinoside, both during two years, and adriamycin every eighth week, for one year. Complete remission rates for the first two periods of therapy were 40% and 55%, whereas that of the last period was 74%. The overall results of the period 1967-1982, showed actuarial duration rates of complete remission, event-free survival and survival, at 60 months, between 2% and 6%, their median duration being of 9, 8 and 10 months respectively. No significant difference was observed between the first two periods or protocols. Protocol 3-AML-83, activated in March 1983, achieved actuarial rates of continuous complete remission, event-free survival, and survival of 51%, 37% and 39% respectively, at 48 months. The difference between the first two periods and the last one was highly significant (P less than 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)
1967年11月至1987年12月期间,371名16岁以下新诊断为急性髓细胞白血病的儿童被纳入连续六个GATLA/GLATHEM方案。该研究分为三个阶段:1967年至1975年、1976年至1982年以及1983年至1987年。在前两个阶段使用了三种诱导方案,并探索了与每月强化交替的不同维持方案;还测试了微小棒状杆菌免疫疗法和司坦唑醇雄激素疗法的效果。代表第三阶段的方案3-AML-83包括一个为期四周的诱导期,使用长春新碱、阿霉素、阿糖胞苷、泼尼松和6-巯基嘌呤,随后是一个为期四周的强化期,使用环磷酰胺、阿糖胞苷和6-巯基嘌呤。维持期包括两年内每日口服6-巯基嘌呤和每月注射阿糖胞苷,以及一年内每八周注射一次阿霉素。前两个治疗阶段的完全缓解率分别为40%和55%,而最后一个阶段为74%。1967 - 1982年期间的总体结果显示,60个月时完全缓解、无事件生存和总生存的精算持续率在2%至6%之间,它们的中位持续时间分别为9个月、8个月和10个月。前两个阶段或方案之间未观察到显著差异。1983年3月启动的方案3-AML-83在48个月时的持续完全缓解、无事件生存和总生存的精算率分别为51%、37%和39%。前两个阶段与最后一个阶段之间的差异非常显著(P小于0.0001)。(摘要截断于250字)