Amadori S, Meloni G, Petti M C, Papa G, Miniero R, Mandelli F
Institute of Hematology, Universities of Rome La Sapienza, Italy.
Leukemia. 1989 Feb;3(2):112-4.
Forty-seven patients with primary refractory, relapsed, and previously untreated, poor risk AML were entered into a phase II study of intermediate dose ARA-C (IDAC) (1 g/m2 i.v. over 6 hr, daily for 6 days) with sequential mitoxantrone (MITOX) (6 mg/m2 i.v. bolus 3 hr after the end of each ARA-C infusion). Overall, complete remission was induced in 31 patients (66%), and 1 additional patient entered a partial remission. Seven patients (15%) died of infection during marrow hypoplasia. Response to IDAC + MITOX was influenced by sensitivity to previous therapy: patients with primary refractory and early relapse AML responded less well to the regimen (CR rate 28% and 33%, respectively), as compared to those with previously untreated (CR rate 64%) or late relapse disease (CR rate 85%). Sixteen patients continue in CR at 1-12+ months. Except for the expected severe myelosuppression, the regimen was well tolerated with minimal extramedullary toxicity. The data indicate that the sequential combination of IDAC and MITOX is an effective and tolerable regimen for AML. Consideration should be given to applying this program at earlier stages of AML therapy.
47例原发性难治性、复发性以及既往未治疗的高危急性髓细胞白血病（AML）患者进入了一项关于中等剂量阿糖胞苷（IDAC）（1 g/m²静脉滴注6小时，每日1次，共6天）序贯米托蒽醌（MITOX）（每次阿糖胞苷输注结束后3小时静脉推注6 mg/m²）的II期研究。总体而言，31例患者（66%）诱导获得完全缓解，另有1例患者进入部分缓解。7例患者（15%）在骨髓增生低下期间死于感染。对IDAC + MITOX的反应受既往治疗敏感性的影响：原发性难治性和早期复发AML患者对该方案的反应较差（完全缓解率分别为28%和33%），而既往未治疗患者（完全缓解率64%）或晚期复发患者（完全缓解率85%）则较好。16例患者在1至12 +个月时持续处于完全缓解状态。除了预期的严重骨髓抑制外，该方案耐受性良好，髓外毒性极小。数据表明，IDAC和MITOX序贯联合是一种治疗AML有效且耐受性良好的方案。应考虑在AML治疗的早期阶段应用该方案。
