Medical Clinic and Policlinic I, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany; NCT Trial Center, National Center of Tumor Diseases, German Cancer Research Center (DKFZ), Heidelberg.
NCT Trial Center, National Center of Tumor Diseases, German Cancer Research Center (DKFZ), Heidelberg; Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg.
Haematologica. 2021 Dec 1;106(12):3100-3106. doi: 10.3324/haematol.2021.278722.
The aim of this study was to characterize a large series of 154 patients with acute promyelocytic leukemia (median age, 53 years; range, 18-90 years) and evaluate real-life outcome after up-front treatment with arsenic trioxide and all-trans retinoic acid. All patients were included in the prospective NAPOLEON registry (NCT02192619) between 2013 and 2019. The acute promyelocytic leukemia was de novo in 91% (n=140) and therapy-related in 9% (n=14); 13% (n=20) of the patients were older than 70 years. At diagnosis bleeding/hemorrhage was present in 38% and thrombosis in 3%. Complete remission was achieved in 152 patients (99%), whereas two patients (1%) experienced induction death within 18 days after starting therapy. With a median follow-up of 1.99 years (95% confidence interval: 1.61-2.30 years) 1-year and 2-year overall survival rates were 97% (95% confidence interval: 94-100%) and 95% (95% confidence interval: 91-99%), respectively. Age above 70 years was associated with a significantly shorter overall survival (P<0.001) compared to that of younger patients. So far no relapses have been observed. Six patients (4%) died in complete remission at a median of 0.95 years after diagnosis (range, 0.18-2.38 years). Our data confirm the efficiency and durability of arsenic trioxide and all-trans retinoic acid therapy in the primary management of adults with low-/intermediate-risk acute promyelocytic leukemia in the real-life setting, irrespective of age.
本研究旨在对 154 例急性早幼粒细胞白血病患者（中位年龄为 53 岁，范围为 18-90 岁）进行特征分析，并评估三氧化二砷和全反式维甲酸一线治疗的真实临床结局。所有患者均于 2013 年至 2019 年纳入前瞻性 NAPOLEON 登记研究（NCT02192619）。新发急性早幼粒细胞白血病占 91%（n=140），治疗相关性占 9%（n=14）；13%（n=20）的患者年龄>70 岁。诊断时存在出血/出血的患者占 38%，存在血栓的患者占 3%。152 例患者（99%）获得完全缓解，而 2 例患者（1%）在开始治疗后 18 天内发生诱导性死亡。中位随访时间为 1.99 年（95%置信区间：1.61-2.30 年），1 年和 2 年总生存率分别为 97%（95%置信区间：94-100%）和 95%（95%置信区间：91-99%）。与年轻患者相比，年龄>70 岁与总生存时间显著缩短相关（P<0.001）。迄今为止，未观察到复发。6 例患者（4%）在完全缓解后中位时间为 0.95 年死亡（范围为 0.18-2.38 年）。我们的数据证实了三氧化二砷和全反式维甲酸在真实环境中治疗低/中危急性早幼粒细胞白血病成人患者中的疗效和持久性，与年龄无关。
