Kobayashi T, Miyawaki S, Tanimoto M, Kuriyama K, Murakami H, Yoshida M, Minami S, Minato K, Tsubaki K, Ohmoto E, Oh H, Jinnai I, Sakamaki H, Hiraoka A, Kanamaru A, Takahashi I, Saito K, Naoe T, Yamada O, Asou N, Kageyama S, Emi N, Matsuoka A, Tomonaga M, Ohno R
Second Department of Internal Medicine, Mie University School of Medicine, Tsu, Japan.
J Clin Oncol. 1996 Jan;14(1):204-13. doi: 10.1200/JCO.1996.14.1.204.
We analyzed complete remission (CR), disease-free survival (DFS), and event-free survival (EFS) rates in two groups of patients treated with either N4-behenoyl-1-beta-D-arabinosylcytosine (BHAC) or cytarabine, and analyzed DFS with or without ubenimex, a biologic response modifier.
Newly diagnosed patients with acute myeloid leukemia (AML) were randomized to receive either BHAC or cytarabine as remission-induction combination chemotherapy and two courses of consolidation therapy. After maintenance/intensification therapy, patients in CR were randomized to receive either ubenimex and no drug.
Of 341 patients registered, 326 were assessable. The age of assessable patients ranged from 15 to 82 years (median, 48). The overall CR rate was 77%: 72% in the BHAC group and 81% in the cytarabine group, and there was a significant difference between the two groups (P = .035, chi 2 test). The predicted 55-month EFS rate of all patients was 30%: 23% in the BHAC group and 35% in the cytarabine group, with a significant difference between groups (P = .0253). The predicted 55-month DFS rate of all CR patients was 38% and that of CR patients less than 50 years of age was 47%. There was no significant difference in DFS between the ubenimex group and the group that did not receive ubenimex.
Analyses of our clinical trial showed that the use of BHAC in remission-induction therapy and in consolidation therapy resulted in poorer CR and EFS rates in adult AML patients compared with the use of cytarabine at the doses and schedules tested. Immunotherapy with ubenimex after the end of all chemotherapy did not improve DFS.
我们分析了两组分别接受N4-山嵛酰-1-β-D-阿拉伯糖胞苷（BHAC）或阿糖胞苷治疗的患者的完全缓解（CR）率、无病生存率（DFS）和无事件生存率（EFS），并分析了联合或不联合生物反应调节剂乌苯美司的DFS情况。
新诊断的急性髓系白血病（AML）患者被随机分配接受BHAC或阿糖胞苷作为缓解诱导联合化疗及两个疗程的巩固治疗。在维持/强化治疗后，处于CR的患者被随机分配接受乌苯美司或不接受任何药物治疗。
在登记的341例患者中，326例可进行评估。可评估患者的年龄范围为15至82岁（中位数为48岁）。总体CR率为77%：BHAC组为72%，阿糖胞苷组为81%，两组之间存在显著差异（P = 0.035，卡方检验）。所有患者预计的55个月EFS率为30%：BHAC组为23%，阿糖胞苷组为35%，组间差异显著（P = 0.0253）。所有CR患者预计的55个月DFS率为38%，年龄小于50岁的CR患者为47%。乌苯美司组与未接受乌苯美司的组之间的DFS无显著差异。
我们的临床试验分析表明，在测试的剂量和疗程下，与使用阿糖胞苷相比，在缓解诱导治疗和巩固治疗中使用BHAC会导致成人AML患者的CR率和EFS率更低。在所有化疗结束后使用乌苯美司进行免疫治疗并未改善DFS。
