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三氧化二砷一线治疗老年初诊急性早幼粒细胞白血病的长期疗效和安全性。

Long-term efficacy and safety of arsenic trioxide for first-line treatment of elderly patients with newly diagnosed acute promyelocytic leukemia.

机构信息

Central Laboratory, the First Affiliated Hospital, Harbin Medical University, Heilongjiang, China.

出版信息

Cancer. 2013 Jan 1;119(1):115-25. doi: 10.1002/cncr.27650. Epub 2012 Aug 28.

DOI:10.1002/cncr.27650
PMID:22930197
Abstract

BACKGROUND

The prognosis of acute promyelocytic leukemia (APL) in the elderly is poorer than that of younger patients after treatment with all-trans retinoic acid plus chemotherapy, which is the current standard therapy for APL. A significantly higher mortality during consolidation therapy was found, which is mainly due to deaths from sepsis following chemotherapy-induced myelosuppression.

METHODS

A total of 33 patients aged 60 years or older with de novo APL were treated with single-agent arsenic trioxide (ATO) for remission induction and postremission therapy. The postremission therapy continued for up to 4 years.

RESULTS

Twenty-nine patients (87.9%) achieved a hematologic complete remission, and the most common adverse event during remission induction was leukocytosis (63.6%). Definite differentiation syndrome was observed in 5 patients. Nonhematologic adverse events were all manageable and reversible. Twenty-eight patients proceeded to postremission therapy. Adverse effects during postremission therapy were mild, transient, and no treatment was required. No patients died from ATO-related toxicities. With a median follow-up of 99 months, the 10-year cumulative incidence of relapse, overall survival, disease-free survival, and cause-specific survival were 10.3%, 69.3%, 64.8%, and 84.8%, respectively, which are comparable with those in the younger APL partners. No significant risks for development of chronic arsenicosis or second malignancy were observed during the follow-up period.

CONCLUSIONS

The results indicate that the single-agent ATO regimen is safe and effective with long-term durable remission, and could be used as first-line treatment for elderly patients with de novo APL.

摘要

背景

与全反式维甲酸联合化疗相比,老年急性早幼粒细胞白血病(APL)患者在接受治疗后的预后较差,这是目前治疗 APL 的标准疗法。在巩固治疗期间发现死亡率明显更高,这主要是由于化疗引起的骨髓抑制后败血症导致的死亡。

方法

共对 33 名 60 岁或以上的初治 APL 患者采用单药三氧化二砷(ATO)进行缓解诱导和缓解后治疗。缓解后治疗最长持续 4 年。

结果

29 名患者(87.9%)达到血液学完全缓解,缓解诱导期间最常见的不良事件是白细胞增多(63.6%)。5 名患者出现明确的分化综合征。非血液学不良事件均为可管理和可逆的。28 名患者接受缓解后治疗。缓解后治疗期间的不良反应轻微、短暂,无需治疗。没有患者因 ATO 相关毒性而死亡。中位随访 99 个月后,10 年累积复发率、总生存率、无病生存率和特异性生存率分别为 10.3%、69.3%、64.8%和 84.8%,与年轻的 APL 患者相当。在随访期间,未观察到发生慢性砷中毒或第二恶性肿瘤的显著风险。

结论

结果表明,单药 ATO 方案安全有效,长期缓解持久,可作为初治老年 APL 患者的一线治疗方法。

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