Jehn U, Zittoun R
Onkologie. 1985 Apr;8(2):94-5. doi: 10.1159/000215627.
Twenty-five institutions are participating in a randomized trial of the E.O.R.T.C. for improvement of remission incidence, disease-free interval and survival in adult acute non-lymphocytic leukemia. In order to delay the time of relapse, an intensive cyclic therapy is employed early after achievement of complete remission (C.R.) using either the same drugs of the induction regimen or rotating combinations of alternative drugs, e.g. mAMSA, 5-AZA and HD-Ara C. So far 266 patients entered the trial with a median age of 45 yrs. The overall C.R. rate is 71%; 52% of the responders reached C.R. after 1 cycle of induction treatment. 10% of the patients died within the first 7 days of induction or due to hypoplasia, 13% were absolute resistant to this regimen. Fifty-eight patients are randomized to 'maintenance' arm I, 54 to arm II, 79/112 patients are still under study. Treatment toxicity is tolerable. In 7% and 3% excessive toxicity was a reason for going off study during induction or 'maintenance'. As far as remission duration or survival within the two treatment arms is concerned, it is too early to draw any conclusions.
25家机构正在参与欧洲癌症研究与治疗组织（E.O.R.T.C.）开展的一项随机试验，以提高成人急性非淋巴细胞白血病的缓解率、无病生存期和生存率。为了延迟复发时间，在完全缓解（C.R.）达成后早期采用强化循环疗法，使用诱导方案中的相同药物或交替药物的轮换组合，如米托蒽醌、5-氮杂胞苷和大剂量阿糖胞苷。到目前为止，266例患者进入试验，中位年龄为45岁。总体缓解率为71%；52%的缓解者在1个周期的诱导治疗后达到完全缓解。10%的患者在诱导的前7天内死亡或因发育不全死亡，13%的患者对该方案完全耐药。58例患者被随机分配到“维持”治疗组I，54例分配到治疗组II，79/112例患者仍在研究中。治疗毒性是可耐受的。在7%和3%的患者中，过度毒性是在诱导或“维持”治疗期间退出研究的原因。就两个治疗组的缓解持续时间或生存率而言，现在得出任何结论都为时过早。
