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日本 AML 的真实世界数据:JALSG 临床观察研究-11(JALSG-CS-11)的结果。

Real-world data of AML in Japan: results of JALSG clinical observational study-11 (JALSG-CS-11).

机构信息

Department of Hematology, NTT Medical Center Tokyo, Higashi-Gotanda 5-9-22, Shinagawa-Ku, Tokyo, 141-8625, Japan.

Kanazawa University, Kanazawa, Japan.

出版信息

Int J Hematol. 2024 Jan;119(1):24-38. doi: 10.1007/s12185-023-03677-w. Epub 2023 Nov 28.

DOI:10.1007/s12185-023-03677-w
PMID:
38015362
Abstract

This report covers acute myeloid leukemia (AML) results from a multicenter, prospective observational study of AML, myelodysplastic syndromes, and chronic myelomonocytic leukemia in Japan. From August 2011 to January 2016, 3728 AML patients were registered. Among them, 42% were younger than 65, and the male-to-female ratio was 1.57:1. With a median follow-up time of 1807 days (95% confidence interval [CI]: 1732-1844 days), the estimated 5-year overall survival (OS) rate in AML patients (n = 3707) was 31.1% (95% CI: 29.5-32.8%). Trial-enrolled patients had a 1.7-fold higher OS rate than non-enrolled patients (5-year OS, 58.9% [95% CI: 54.5-63.1%] vs 35.5% [33.3-37.8%], p < 0.0001). Women had a higher OS rate than men (5-year OS, 34% [95% CI; 31.4-36.7%] vs 27.7% [25.7-29.7%], p < 0.0001). The OS rate was lower in patients aged 40 and older than those under 40, and even lower in those over 65 (5-year OS for ages < 40, 40-64, 65-74, ≥ 75: 74.5% [95% CI; 69.3-79.0%] vs 47.5% [44.4-50.6%] vs 19.3% [16.8-22.0%] vs 7.3% [5.5-9.4%], respectively). This is the first paper to present large-scale data on survival and clinical characteristics in Japanese AML patients.

摘要

本报告涵盖了一项多中心、前瞻性观察性研究的急性髓系白血病(AML)结果,该研究涉及日本的 AML、骨髓增生异常综合征和慢性粒单核细胞白血病。从 2011 年 8 月至 2016 年 1 月,共登记了 3728 例 AML 患者。其中,42%的患者年龄小于 65 岁,男女比例为 1.57:1。中位随访时间为 1807 天(95%置信区间[CI]:1732-1844 天),3707 例 AML 患者的估计 5 年总生存率(OS)为 31.1%(95%CI:29.5-32.8%)。入组患者的 OS 率比未入组患者高 1.7 倍(5 年 OS,58.9%[95%CI:54.5-63.1%]比 35.5%[33.3-37.8%],p<0.0001)。女性的 OS 率高于男性(5 年 OS,34%[95%CI:31.4-36.7%]比 27.7%[25.7-29.7%],p<0.0001)。40 岁及以上患者的 OS 率低于 40 岁以下患者,而 65 岁以上患者的 OS 率更低(年龄<40、40-64、65-74、≥75 岁的 5 年 OS:74.5%[95%CI:69.3-79.0%]比 47.5%[44.4-50.6%]比 19.3%[16.8-22.0%]比 7.3%[5.5-9.4%])。这是第一篇报告日本 AML 患者生存和临床特征的大型研究论文。

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