Jehn U
Department of Hematology and Oncology, University of Munich, FRG.
Leuk Lymphoma. 1994 Sep;15(1-2):99-112. doi: 10.3109/10428199409051684.
The long-term results of postremission chemotherapy for 122 consecutive, unselected adults (15-65 years) with acute myeloid leukemia (AML) were assessed in two sequential prospective studies involving an identical 3/7-type induction regimen, and in those achieving remission, another course for early consolidation using 1 day of daunorubicin instead of three. Forty-one patients reaching C.R. during the first study period, were treated with an intensive ablative maintenance ("IM") program for a period of 9 months. They were randomized to either 6 cycles of induction-type regimen or to 6 cycles of an alternating-type regimen consisting of high-dose (HD)-Ara C/AMSA or 5-azacytidine/AMSA every 6 weeks. There was no difference in disease-free survival (DFS) or survival. Results are compared with 27 patients reaching C.R. on the subsequent protocol where IM was replaced by intensive, short-term consolidation ("IC") using 1 cycle of intermediate-dose Ara C plus AMSA and 1 cycle of HD-AraC/AMSA. Fifteen patients received both courses of IC as scheduled, 12 refused the second cycle. There was no significant difference in DFS or survival. Seventeen out of the 122 patients refused either IM or IC following early consolidation ("refusals"). They received no further treatment and served as control. Fourteen percent of all patients underwent autologous or allogeneic bone marrow transplantation (BMT) at different stages of their disease, equally distributed amongst the IM and IC-group. Median DFS was 3.3 months in the refusal group, 12.4 months in the IM-group, and 18.4 months in the IC-group when censored for BMT (p = 0.01) with 6%, 12%, and 40% in C.C.R. at 50 months. Accordingly, median survival was 5.4, 20 and 47 months (p = 0.001) with 6%, 15%, and 45% of patients alive at 5 years. There was a definite trend (p = 0.14) for a higher proportion of long-term survivors in the IM-group when BMT was performed (not censored), while long-term survival was identical in the IC-group whether BMT was considered for analyses (not censored) or not (censored). Median follow-up for both studies is 5.6 years, the longest, 10 years. In conclusion, progressive increments in the intensity of postremission therapy yields in a graded, significant improvement of remission duration and survival.
在两项连续的前瞻性研究中，对122例未经挑选的15至65岁急性髓系白血病（AML）成年患者进行缓解后化疗的长期结果进行了评估。这两项研究采用相同的3/7型诱导方案，对于达到缓解的患者，早期巩固治疗采用1天柔红霉素而非3天。在第一项研究期间达到完全缓解（C.R.）的41例患者，接受了为期9个月的强化清髓维持（“IM”）方案治疗。他们被随机分为接受6个周期的诱导型方案或6个周期的交替型方案，交替型方案为每6周使用高剂量（HD）阿糖胞苷/安吖啶或5-氮杂胞苷/安吖啶。无病生存期（DFS）或总生存期无差异。将结果与后续方案中达到C.R.的27例患者进行比较，在后续方案中，IM被使用1个周期的中剂量阿糖胞苷加安吖啶和1个周期的HD-阿糖胞苷/安吖啶的强化短期巩固（“IC”）所取代。15例患者按计划接受了两个疗程的IC治疗，12例拒绝了第二个周期。DFS或总生存期无显著差异。122例患者中有17例在早期巩固治疗后拒绝IM或IC（“拒绝者”）。他们未接受进一步治疗并作为对照。所有患者中有14%在疾病的不同阶段接受了自体或异基因骨髓移植（BMT），在IM组和IC组中分布均匀。当对BMT进行审查时，拒绝组的中位DFS为3.3个月，IM组为12.4个月，IC组为18.4个月（p = 0.01），50个月时持续完全缓解（C.C.R.）的比例分别为6%、12%和40%。相应地，中位生存期分别为5.4、20和47个月（p = 0.001），5年时存活患者的比例分别为6%、15%和45%。当进行BMT（未审查）时，IM组长期存活者的比例有明显上升趋势（p = 0.14），而无论是否考虑BMT进行分析（未审查），IC组的长期生存率相同（审查）。两项研究的中位随访时间为5.6年，最长为10年。总之，缓解后治疗强度的逐步增加可使缓解持续时间和生存期得到分级、显著改善。
