Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA Group
Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA Group
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DOI：
10.1182/blood-2010-03-276196
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发表时间：
2010-10-28
期刊：
影响因子：
20.3
通讯作者：
Mandelli, Franco
中科院分区：
文献类型：
--
作者：
Lo-Coco, Francesco;Avvisati, Giuseppe;Mandelli, Franco
在确定急性早幼粒细胞白血病（APL）患者接受全反式视黄酸和依达柔比星（AIDA）样治疗的离散复发风险类别后，意大利Gruppo Malattie Ematologiche dell'Adulto （GIMEMA）为新诊断的APL （AIDA-2000）设计了一种方案，其中缓解后治疗是风险适应的。低/中等风险患者在3个基于蒽环类药物的巩固疗程中获得缓解，而高风险患者接受与先前非风险适应性的AIDA-0493试验相同的时间表，包括阿糖胞苷。此外，AIDA-2000中的所有患者在每次巩固期间接受全反式维甲酸（ATRA）治疗15天。诱导后，636例患者中有600例（94.3%）和445例患者中有420例（94.4%）分别在AIDA-0493和AIDA-2000中获得完全缓解。6年总生存率和累计复发率（CIR）分别为78.1%对87.4% （P = 0.001）和27.7%对10.7% （P < 0.001）。AIDA-2000患者的CIR显著降低在高危组最为明显（分别为49.7%和9.3%,P < 0.0001）。我们的数据证实，对于低/中危患者，基于蒽环类药物的巩固至少与含阿糖胞苷的方案同样有效，并表明包括ATRA在内的风险适应策略可改善新诊断APL的预后。此外，我们的研究结果强调了阿糖胞苷联用蒽环类药物和ATRA在高危人群巩固中的作用。该试验在www.clinicaltrials.gov上注册为#NCT 001064570。[血液，2010;116(17):3171-3179]
After the identification of discrete relapse-risk categories in patients with acute promyelocytic leukemia (APL) receiving all-trans retinoic and idarubicin (AIDA)-like therapies, the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) designed a protocol for newly diagnosed APL (AIDA-2000) in which postremission treatment was risk-adapted. Patients with low/intermediate risk received remission at 3 anthracycline-based consolidation courses, whereas high-risk patients received the same schedule as in the previous, non-risk-adapted AIDA-0493 trial including cytarabine. In addition, all patients in the AIDA-2000 received all-trans retinoic acid (ATRA) for 15 days during each consolidation. After induction, 600 of 636 (94.3%) and 420 of 445 (94.4%) patients achieved complete remission in the AIDA-0493 and AIDA-2000, respectively. The 6-year overall survival and cumulative incidence of relapse (CIR) rates were 78.1% versus 87.4% (P = .001) and 27.7% versus 10.7% (P < .0001). Significantly lower CIR rates for patients in the AIDA-2000 were most evident in the high-risk group (49.7% vs 9.3%, respectively, P < .0001). Our data confirm that anthracycline-based consolidation is at least equally effective as cytarabine-containing regimens for low-/intermediate-risk patients and suggest that a risk-adapted strategy including ATRA for consolidation improves outcome in newly diagnosed APL. Furthermore, our results highlight the role of cytarabine coupled to anthracyclines and ATRA during consolidation in the high-risk group. This trial was registered at www.clinicaltrials.gov as #NCT 001064570. (Blood. 2010; 116(17): 3171-3179)