All-trans retinoic acid in acute promyelocytic leukemia:: long-term outcome and prognostic factor analysis from the North American Intergroup protocol
All-trans retinoic acid in acute promyelocytic leukemia:: long-term outcome and prognostic factor analysis from the North American Intergroup protocol
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DOI：
10.1182/blood-2002-02-0632
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发表时间：
2002-12-15
期刊：
影响因子：
20.3
通讯作者：
Wiernik, PH
中科院分区：
文献类型：
--
作者：
Tallman, MS;Andersen, JW;Wiernik, PH
我们先前报道了全反式维甲酸（ATRA）在急性早幼粒细胞白血病（APL）患者诱导和维持治疗中的获益。为了确定这种益处的持久性并确定重要的预后因素，报告了北美组间APL试验的长期随访。共有350例新诊断的APL患者随机接受柔红霉素和阿糖胞苷（DA）或ATRA诱导，然后ATRA维持或观察巩固化疗。完全缓解（CR）率在ATRA和DA组之间没有显著差异（分别为70%和73%）。然而，5年无病生存率（DFS）和总生存率（OS）在诱导时ATRA组比DA组长（分别为69%和29%，69%和45%）。基于诱导和维持随机化，随机分配至DA和观察组的患者的5年DFS为16%，DA和ATRA组为47%，ATRA和观察组为55%，ATRA和ATRA组为74%。当仅考虑CR时，任何诱导方案在任何亚组中均无优势。然而，女性、经典的M3形态（与微粒变体[M3 v]相比）和治疗-白细胞计数（WBC）相互作用（ATRA/WBC低于2 × 10（9）/L [2000/穆尔]最好，DA/WBC高于2 × 10（9）/L最差）均与DFS改善显著相关（P
We previously reported a benefit for all-trans retinoic acid (ATRA) in both induction and maintenance therapy in patients with acute promyelocytic leukemia (APL). To determine the durability of this benefit and identify important prognostic factors, long-term follow-up of the North American Intergroup APL trial is reported. A total of 350 patients with newly diagnosed APL were randomized to either daunorubicin and cytarabine (DA) or ATRA for induction and then either ATRA maintenance or observation following consolidation chemotherapy. The complete remission (CR) rates were not significantly different between the ATRA and DA groups (70% and 73%, respectively). However, the 5-year disease-free survival (DFS) and overall survival (OS) were longer with ATRA than with DA for induction (69% vs 29% and 69% vs 45%, respectively). Based on both induction and maintenance randomizations, the 5-year DFS was 16% for patients randomized to DA and observation, 47% for DA and ATRA, 55% for ATRA and observation, and 74% for ATRA and ATRA. There was no advantage of either induction regimen among any subgroups when CR alone was considered. However, female sex, classical M3 morphology (vs the microgranular variant [M3v]), and treatment-white blood cell count (WBC) interaction (ATRA/WBC below 2 x 10(9)/L [2000/muL] best, DA/WBC above 2 x 10(9)/L worst) were each significantly associated with improved DFS (P