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新诊断多发性骨髓瘤患者心血管不良事件的真实世界分析

A real-world analysis of cardiovascular adverse events in newly diagnosed multiple myeloma

    摘要
  • 摘要:
    目的 探讨中国新诊断多发性骨髓瘤（newly diagnosed multiple myeloma, NDMM）患者在现行治疗模式下，发生心血管不良事件（cardiovascular adverse events, CVAE）的临床特征、相关药物、危险因素及预后情况。
    方法 回顾性分析2013年1月至2021月10月于复旦大学附属中山医院诊治的NDMM患者。采用1:1倾向评分匹配平衡组间混杂因素，比较不同治疗组与对照组间CVAE的差异。通过Fine-Gray竞争风险模型识别CVAE的独立危险因素。采用Kaplan-Meier生存曲线和log-rank检验评估患者的总生存期和无进展生存期。
    结果 共纳入829例NDMM患者，中位随访时间为33.1个月。一线治疗期间，共65例（7.8%）患者发生CVAE，累计记录74例不良事件，其中52.7%为3级及以上。常见类型包括心律失常（以心房颤动为主）、血栓事件和心力衰竭。从治疗开始至首次发生CVAE的中位时间为26 d，其中血栓事件的中位发生时间显著晚于其他不良事件（76 d vs 19 d, P＝0.003）。免疫调节剂暴露与较高的血栓事件发生率相关，而硼替佐米等治疗方案未表现出明显心血管毒性。多因素分析显示，美国东部肿瘤协作组体能状态评分＞2分、治疗前3个月内存在症状性心脏病、估算肾小球滤过率≤50 mL·min−1·(1.73m2)−1为CVAE的独立危险因素。与未发生CVAE的患者相比，发生CVAE的患者无进展生存期和总生存期均显著缩短（P＜0.001），且心血管相关死亡率更高。
    结论  NDMM患者一线治疗期间CVAE发生率较高，发生CVAE的患者预后较差。合并心血管基础疾病者CVAE风险显著增高。

     

    Abstract:
    Objective To evaluate the characteristics, related therapeutic regimens, risk factors, and prognosis of cardiovascular adverse events (CVAEs) in the current therapy of newly diagnosed multiple myeloma (NDMM) patients in China.
    Methods A retrospective observational study was performed on patients with NDMM treated at Zhongshan Hospital, Fudan University, from January 2013 to October 2021. A 1:1 propensity score matching was employed to balance baseline confounders between the therapeutic group and the control group, and differences of CVAE were compared between the corresponding groups. Independent risk factors for CVAEs were identified through Fine-Gray competing risk regression models. Kaplan-Meier survival curves and log-rank tests were used to assess overall survival and progression-free survival of patients.
    Results A total of 829 patients with NDMM were analyzed, with a median of 33.1 months of follow-up for survivors. CVAEs occurred in 65 of 829 NDMM patients (7.8%) during first-line treatment, and a total of 74 events were recorded, with 52.7% grade 3 or greater in severity. Arrhythmia (particularly atrial fibrillation), thrombotic events (TEs), and heart failure were the most common types. The median time from treatment to the first occurrence of CVAEs was 26 days, while the medium occurrence time of TEs was later than the other events (76 d vs 19 d, P＝0.003). The exposure to immunomodulatory drugs was related to a higher incidence of TEs, whereas other therapeutic regimens, including Bortezomib, didn’t show the effect of cardiovascular toxicity. Results of multivariate analysis showed that Eastern Cooperative Oncology Group performance status ＞2, symptomatic heart diseases within three months before treatment, and estimated glomerular filtration rate≤50 mL·min−1·(1.73m2)−1 were independent risk factors for CVAEs. Compared with patients without CVAE, patients who experienced CVAEs had significantly inferior progression free survival (P＜0.001) and overall survival (P＜0.001), and higher cardiovascular mortality.
    Conclusions The incidence of CVAE is relatively high during first-line treatment in NDMM patients, and the prognosis of CVAE patients is poor. The risk of CVAE is significantly increased in patients with underlying cardiovascular diseases.

     

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