高龄初治急性髓系白血病VA方案与传统方案的近远期疗效比较

Comparison of short- and long-term efficacy of venetoclax combined with azacitidine and traditional regimens in older patients with newly diagnosed acute myeloid leukemia

    摘要
  • 摘要:
    目的 分析高龄（年龄≥75岁）急性髓系白血病（acute myeloid leukemia，AML）的临床特征，并比较维奈克拉联合阿扎胞苷（VA）方案与传统方案在高龄初治AML患者中的疗效和生存差异。
    方法 回顾性分析2016年5月至2025年4月于北京大学国际医院收治的42例高龄初治AML患者资料。最终接受治疗的患者共34例，其中15例接受VA方案治疗，19例接受传统方案治疗。评估两组完全缓解率（complete response，CR）或形态学完全缓解伴血细胞计数未完全恢复（complete remission with incomplete hematologic recovery，CRi）、无白血病生存期（leukemia-free survival，LFS）和总生存期（overall survival，OS）。
    结果 患者中位年龄80.0（77.0～82.5）岁。88.1%患者合并有慢性基础疾病，28.6%有前驱血液病史，19.9%合并其他恶性肿瘤。最终有34例可评估疗效，19例（55.9%）患者经诱导获得CR/CRi，1例（2.9%）部分缓解（partial remission，PR），未缓解14例（41.2%）。VA方案组的CR/CRi率为66.7%（10/15），显著高于传统方案组47.4%（9/19）（χ2=4.72，P=0.03）。中位随访48（1～96）个月，总体中位生存12个月（95%CI：7.416～16.584）；VA方案组的中位OS为27个月（95%CI：9.722～44.278），显著优于传统方案组的8个月（95%CI：2.622～13.378），P=0.045。安全性方面，85.3%的患者出现感染并发症，VA方案组未报告早期死亡，而传统方案组发生3例早期死亡。
    结论 在高龄初治AML患者中，VA方案较传统治疗方案显著延长总生存期，且安全性可控，可作为一线治疗选择。

     

    Abstract:
    Objective  To investigate the clinical characteristics of acute myeloid leukemia (AML) in older patients (≥75 years) and compare the efficacy and survival outcomes of venetoclax combined with azacitidine (VA regimen) and traditional treatment regimens in older patients with newly diagnosed AML.
    Methods A retrospective analysis was conducted on 42 older patients with newly diagnosed AML who were treated in Peking University International Hospital, between May 2016 and April 2025. Among them, 15 patients received the VA regimen, and 19 received traditional regimens. The complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) rate, leukemia-free survival (LFS), and overall survival (OS) were compared between the two groups.
    Results The median patient age was 80 years (range, 77.0‒82.5). Thirty-seven patients (88.1%) had chronic comorbidities, 12 (28.6%) had a history of antecedent hematologic disorders, and eight (19.9%) had other malignancies. Among the 34 evaluable patients, 19 (55.9%) achieved CR/CRi, one (2.9%) achieved partial remission (PR), and 14 (41.2%) showed no response. The CR/CRi rate was 66.7% (10/15) in the VA group versus 47.4% (9/19) in the traditional group (χ2=4.72, P=0.03). With a median follow-up of 48 months (range, 1–96 months), the median OS was 12 months (95% confidence interval CI:7.416–16.584) for the entire cohort. The VA group had a significantly longer median OS (27 months; 95%CI: 9.722–44.278) than the traditional group (8 months; 95%CI: 2.622–13.378) (P=0.045). Regarding safety, 85.3% of patients experienced infectious complications; no early deaths occurred in the VA group, whereas three occurred in the traditional group.
    Conclusions In older patients with newly diagnosed AML, the VA regimen can markedly prolong OS with manageable safety compared with traditional treatment regimens, supporting its use as a first-line treatment option.

     

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