Martiat P, Ghilain J M, Ferrant A, Doyen C, Delannoy A, Chatelain C, Bosly A, Michaux J L, Sokal G
Department of Haematology, University of Louvain Medical School, Cliniques Universitaires Saint-Luc, Brussels.
Eur J Haematol. 1990 Sep;45(3):164-7. doi: 10.1111/j.1600-0609.1990.tb00445.x.
52 patients with refractory or relapsed acute myeloid leukaemia (AML) were randomly assigned to receive a combination of high-dose cytosine arabinoside (HD Ara-C), 3 g/m2/d and either mitoxantrone (MTX), 7 mg/m2/d (5 mg if older than 60 yr) or m-amsacrine (AMSA), 120 mg/m2/d (90 mg if older than 60 yr) for 5 d. The overall response rate was 50% and did not differ significantly in the two groups (46% for AMSA and 56% for MTX, p = 0.415). The median survival was 11 months (8 months for AMSA and 12 months for MTX, p = 0.326) and the median duration of complete remission (CR) was 11 months for AMSA and 12 months for MTX (p = 0.643). In relapsed patients, the only significant predictive factor for obtaining a complete response was the length of first complete remission. Patients with a first CR shorter than 6 months had a CR rate of 36% while it was 65% if the first CR lasted more than 6 months (p = 0.03). Severe (WHO grade III-IV) gastro-intestinal toxicity was more frequent in the AMSA group (27% vs 4%, p = 0.021). Treatment-related death occurred in 4 patients in the AMSA group and in 2 patients in the MTX group (p = 0.097). We conclude that neither of these two treatment modalities was shown to be superior in terms of CR rate and survival, with a better tolerance for MTX.
52例难治性或复发性急性髓系白血病（AML）患者被随机分配接受大剂量阿糖胞苷（HD Ara-C）联合治疗，剂量为3 g/m²/d，同时联合米托蒽醌（MTX），7 mg/m²/d（60岁以上患者为5 mg）或安吖啶（AMSA），120 mg/m²/d（60岁以上患者为90 mg），持续5天。总缓解率为50%，两组之间无显著差异（AMSA组为46%，MTX组为56%，p = 0.415）。中位生存期为11个月（AMSA组为8个月，MTX组为12个月，p = 0.326），完全缓解（CR）的中位持续时间AMSA组为11个月，MTX组为12个月（p = 0.643）。在复发患者中，获得完全缓解的唯一显著预测因素是首次完全缓解的时长。首次CR短于6个月的患者CR率为36%，而首次CR持续超过6个月时CR率为65%（p = 0.03）。严重（世界卫生组织III-IV级）胃肠道毒性在AMSA组更为常见（27%对4%，p = 0.021）。AMSA组有4例患者发生治疗相关死亡，MTX组有2例患者发生治疗相关死亡（p = 0.097）。我们得出结论，这两种治疗方式在CR率和生存率方面均未显示出优越性，MTX的耐受性更好。
