口服三氧化二砷联合全反式维甲酸和化疗治疗初诊急性早幼粒细胞白血病：一项 5 年前瞻性研究。
Oral arsenic trioxide incorporation into frontline treatment with all-trans retinoic acid and chemotherapy in newly diagnosed acute promyelocytic leukemia: A 5-year prospective study.
机构信息
Department of Medicine, University of Hong Kong, Hong Kong, China.
Department of Medicine, Tuen Mun Hospital, Hong Kong, China.
出版信息
Cancer. 2019 Sep 1;125(17):3001-3012. doi: 10.1002/cncr.32180. Epub 2019 May 15.
BACKGROUND
Strategies using oral arsenic trioxide (As O ) are efficacious in relapsed acute promyelocytic leukemia (APL), but they have not been examined in newly diagnosed cases.
METHODS
Sixty-two consecutive patients (24 men and 38 women) with a median age of 52 years (range, 22-85 years), 36% of whom had high-risk features, underwent induction with all-trans retinoic acid at 45 mg/m /d, oral As O at 10 mg/d, and ascorbic acid at 1 g/d (the all-trans retinoic acid-arsenic trioxide-ascorbic acid [AAA] regimen) for 6 weeks (with patients younger than 70 years additionally receiving daunorubicin at 50 mg/m /d × 3); they then underwent consolidation with 2 monthly cycles of daunorubicin (50 mg/m /d × 2) and cytarabine (100 mg/m /d × 5) and received AAA maintenance (2 weeks every 8 weeks) for 2 years. A contemporaneous cohort of 37 newly diagnosed patients (15 men and 22 women) with a median age of 51 years (range, 23-78 years), not consenting to oral As O induction but receiving similar induction, consolidation, and AAA maintenance, served as a comparator group; 46% of these patients had high-risk features.
RESULTS
The oral As O induction cohort showed a complete remission (CR) rate of 100%. After a median of 37 months (range, 13-82 months), there were no relapses, so conventional risks (age, leukocyte and platelet counts, and Fms-like tyrosine kinase 3 [FLT3] mutations) were not relevant. The leukemia-free survival (LFS) and overall survival (OS) rates were 100% at 3 years and 94.1% at 5 years. The non-As O induction cohort showed a CR rate of 100%. After a median of 52 months (range, 14-77 months), there were 3 relapses (8%). Comparable patients in the oral As O induction and non-As O induction cohorts showed similar OS, but LFS was significantly superior in the oral As O induction cohort.
CONCLUSIONS
The incorporation of oral As O into induction for newly diagnosed APL was safe and decreased relapses.
背景
使用口服三氧化二砷（As₂O₃）的策略在复发性急性早幼粒细胞白血病（APL）中是有效的，但尚未在新诊断的病例中进行检查。
方法
62 例连续患者（24 名男性和 38 名女性），中位年龄为 52 岁（范围为 22-85 岁），其中 36%具有高危特征，接受全反式维甲酸 45mg/m²/d、口服三氧化二砷 10mg/d 和抗坏血酸 1g/d（全反式维甲酸-三氧化二砷-抗坏血酸[AAA]方案）治疗 6 周（年龄小于 70 岁的患者另外接受达那唑 50mg/m²/d×3）；然后接受 2 个周期的巩固治疗，每个周期包括达那唑（50mg/m²/d×2）和阿糖胞苷（100mg/m²/d×5），并接受 2 年的 AAA 维持治疗（每 8 周 2 周）。一组 37 名新诊断的患者（15 名男性和 22 名女性），中位年龄为 51 岁（范围为 23-78 岁），不同意接受口服三氧化二砷诱导，但接受了类似的诱导、巩固和 AAA 维持治疗，作为对照组；其中 46%的患者具有高危特征。
结果
口服三氧化二砷诱导组的完全缓解（CR）率为 100%。中位随访 37 个月（范围 13-82 个月）后，无复发，因此常规风险（年龄、白细胞和血小板计数以及 Fms 样酪氨酸激酶 3 [FLT3]突变）不相关。3 年时无白血病生存（LFS）和总生存（OS）率为 100%，5 年时为 94.1%。非口服三氧化二砷诱导组的 CR 率为 100%。中位随访 52 个月（范围 14-77 个月）后，有 3 例复发（8%）。在口服三氧化二砷诱导组和非口服三氧化二砷诱导组中，具有可比性的患者的 OS 相似，但 LFS 在口服三氧化二砷诱导组中明显更好。
结论
将口服三氧化二砷纳入新诊断的 APL 诱导治疗是安全的，并降低了复发率。
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