Phase II Study of Single-Agent Arsenic Trioxide for the Front-Line Therapy of Acute Promyelocytic Leukemia
Phase II Study of Single-Agent Arsenic Trioxide for the Front-Line Therapy of Acute Promyelocytic Leukemia
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DOI：
10.1200/jco.2010.32.2107
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发表时间：
2011-07-10
影响因子：
45.3
通讯作者：
Jalili, Mahdi
中科院分区：
文献类型：
--
作者：
Ghavamzadeh, Ardeshir;Alimoghaddam, Kamran;Jalili, Mahdi
目的对急性早幼粒细胞白血病（APL）患者进行长期随访，观察全反式维甲酸联合化疗的治愈率。多项研究表明，单剂三氧化二砷对新诊断的APL有很高的疗效。然而，需要长期的随访结果。患者与方法应用三氧化二砷0.15 mg/kg每日静脉滴注治疗新诊断APL患者197例，直至完全缓解（CR）。达到CR后，患者再接受1至4个疗程的三氧化二砷治疗作为巩固治疗，并每3个月进行一次外周血逆转录酶聚合酶链反应研究（以检测微小残留疾病），直至复发或死亡。结果形态学CR率为85.8%。缓解失败最常见的原因是APL分化综合征导致的早期死亡（13.2%）。早期死亡最重要的预后因素是就诊时白细胞计数高。5年无病生存率（DFS）为66.7%±4% （SE）。5年后复发的CR是罕见的。意向治疗分析的5年总生存率（OS）为64.4%±4%。在达到CR的患者中，OS和DFS相同。结论经长期随访，单药三氧化二砷治疗的新诊断APL患者的DFS和OS发生率较高。
PurposeThe long-term follow-up results of patients with acute promyelocytic leukemia (APL) treated with all-trans retinoic acid and chemotherapy show high cure rates. Several studies have shown high efficacy of single-agent arsenic trioxide in newly diagnosed APL. However, long-term follow-up results are needed.Patients and MethodsOne hundred ninety-seven patients with newly diagnosed APL were treated with arsenic trioxide 0.15 mg/kg daily intravenous infusion until complete remission (CR). After achieving CR, the patients received one to four more courses of therapy with arsenic trioxide as consolidation and were observed with reverse-transcriptase polymerase chain reaction studies from peripheral blood (to detect of minimal residual disease) every 3 months or until relapse or death.ResultsThe morphologic CR rate was 85.8%. The most common cause of remission failure was early death owing to APL differentiation syndrome (13.2%). The most important prognostic factor for early mortality was a high WBC count at presentation. The 5-year disease-free survival (DFS) rate was 66.7% +/- 4% (SE). Relapse after 5 years in CR was rare. The 5-year overall survival (OS) rate by intention-to-treat analysis was 64.4% +/- 4%. In patients who achieved CR, OS and DFS were identical.ConclusionThe long-term follow-up of newly diagnosed patients with APL treated with single-agent arsenic trioxide shows high rates of DFS and OS.