在不适合一线强化化疗的韩国 AML 患者中真实世界的治疗模式和临床结局:CURRENT 研究的一项亚分析,这是一项非干预性、回顾性图表审查。

Real-World Treatment Patterns and Clinical Outcomes in Korean Patients With AML Ineligible for First-Line Intensive Chemotherapy: A Subanalysis of the CURRENT Study, a Non-Interventional, Retrospective Chart Review.

机构信息

Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.

Division of Hematology and Oncology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.

出版信息

J Korean Med Sci. 2023 Nov 13;38(44):e345. doi: 10.3346/jkms.2023.38.e345.

Abstract

BACKGROUND

Although most elderly patients with acute myeloid leukemia (AML) are ineligible for intensive chemotherapy (ICT), treatment options remain limited. CURRENT (UMIN000037786), a real-world, non-interventional, retrospective chart review, evaluated clinical outcomes, clinicopathologic characteristics, and treatment patterns in these patients. We present results from a subanalysis of Korean patients in this study.

METHODS

Patients were aged ≥ 18 years with primary or secondary AML ineligible for ICT who initiated first-line systemic therapy or best supportive care (BSC) between 2015 and 2018 across four centers in Korea. Primary endpoint was overall survival (OS) from diagnosis. Secondary endpoints included progression-free survival (PFS), time to treatment failure, and response rates. Data analyses were primarily descriptive, with time-to-event outcomes estimated using the Kaplan-Meier method, and Cox regression used to determine prognostic factors for survival.

RESULTS

Among 194 patients enrolled, 84.0% received systemic therapy and 16.0% received BSC. Median age at diagnosis was 74 and 78 years, and Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 was reported in 73.0% and 48.4% of patients, respectively; poor cytogenetic risk was reported in 30.1% and 16.1% of patients. Median OS was 7.83 vs. 4.50 months, and median PFS was 6.73 vs. 4.50 months in the systemic therapy vs. BSC groups. Prognostic factors affecting OS included secondary AML (hazard ratio, 1.67 [95% confidence interval, 1.13-2.45]), ECOG performance status ≥ 2 (2.41 [1.51-3.83]), poor cytogenetic risk (2.10 [1.36-3.24]), and Charlson comorbidity index ≥ 1 (2.26 [1.43-3.58]).

CONCLUSION

Clinical outcomes are poor in Korean patients with AML ineligible for ICT who are prescribed current systemic therapies or BSC. There is a substantial unmet need for novel agents (monotherapy or in combination) to improve clinical outcomes in this patient population.

摘要

背景

虽然大多数患有急性髓细胞白血病(AML)的老年患者不适合强化化疗(ICT),但治疗选择仍然有限。CURRENT(UMIN000037786)是一项真实世界、非干预性、回顾性图表审查,评估了这些患者的临床结果、临床病理特征和治疗模式。我们从该研究的韩国患者亚分析中呈现结果。

方法

2015 年至 2018 年间,韩国的四个中心共纳入年龄≥18 岁、不适合 ICT 的原发性或继发性 AML 患者,这些患者开始接受一线系统治疗或最佳支持治疗(BSC)。主要终点是从诊断开始的总生存期(OS)。次要终点包括无进展生存期(PFS)、治疗失败时间和反应率。数据分析主要是描述性的,使用 Kaplan-Meier 方法估计时间事件结果,使用 Cox 回归确定生存的预后因素。

结果

在纳入的 194 名患者中,84.0%接受了系统治疗,16.0%接受了 BSC。诊断时的中位年龄为 74 岁和 78 岁,分别有 73.0%和 48.4%的患者报告了东部合作肿瘤学组(ECOG)表现状态 0 或 1;分别有 30.1%和 16.1%的患者报告了不良细胞遗传学风险。系统治疗组的中位 OS 为 7.83 个月,BSC 组为 4.50 个月;系统治疗组的中位 PFS 为 6.73 个月,BSC 组为 4.50 个月。影响 OS 的预后因素包括继发性 AML(危险比,1.67 [95%置信区间,1.13-2.45])、ECOG 表现状态≥2(2.41 [1.51-3.83])、不良细胞遗传学风险(2.10 [1.36-3.24])和 Charlson 合并症指数≥1(2.26 [1.43-3.58])。

结论

不适合 ICT 的韩国 AML 患者接受当前系统治疗或 BSC 治疗,临床结局较差。迫切需要新型药物(单药或联合用药)来改善这部分患者的临床结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f47e/10643247/6ad1bcba4ad1/jkms-38-e345-g001.jpg

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