Bradstock Kenneth F, Morley Alec, Byth Karen, Szer Jeff, Prosser Ian, Cannell Paul, Irving Ian, Seymour John F
Department of Haematology, Westmead Hospital, Sydney, New South Wales, Australia.
Flinders University and Medical Centre, Adelaide, South Australia, Australia.
Contemp Clin Trials Commun. 2016 Jun 22;4:9-13. doi: 10.1016/j.conctc.2016.06.004. eCollection 2016 Dec 15.
An intensive induction regimen, consisting of idarubicin and high dose cytarabine, was assessed in 19 adult patients, median age 44 years, with newly diagnosed precursor-B acute lymphoblastic leukemia (ALL). Patients achieving a complete response (CR) were given an attenuated consolidation course. The primary endpoints were induction death rate and incidence of serious non-hematological toxicity. Grades 3-4 diarrhoea occurred in 47% of patients during induction. Two patients (11%) died during induction therapy, and 2 were withdrawn due to resistant disease or prolonged marrow hypoplasia. Fifteen patients achieved CR (79%), but levels of minimal residual disease (MRD) after induction were comparable with those previously observed using a modified pediatric protocol. Overall survival at 5 years was 36.8% while leukemia-free survival was 44.1%. An intensive AML protocol used in adults with ALL resulted in substantial toxicity and provided similar levels of cytoreduction to conventional ALL protocols, without improving long-term outcomes.
对19例年龄中位数为44岁、新诊断为前体B细胞急性淋巴细胞白血病（ALL）的成年患者评估了由伊达比星和高剂量阿糖胞苷组成的强化诱导方案。达到完全缓解（CR）的患者接受了减强度巩固疗程。主要终点是诱导死亡率和严重非血液学毒性的发生率。诱导期间47%的患者出现3-4级腹泻。两名患者（11%）在诱导治疗期间死亡，2名患者因疾病耐药或骨髓发育不全持续时间延长而退出。15例患者达到CR（79%），但诱导后微小残留病（MRD）水平与先前使用改良儿科方案观察到的水平相当。5年总生存率为36.8%，无白血病生存率为44.1%。用于成人ALL患者的强化AML方案导致了大量毒性，并且与传统ALL方案相比提供了相似的细胞减灭水平，而没有改善长期预后。
