QTc 公式与癌症患者临床管理的关联。
Association of QTc Formula With the Clinical Management of Patients With Cancer.
机构信息
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.
Eshelman School of Pharmacy, University of North Carolina at Chapel Hill.
出版信息
JAMA Oncol. 2022 Nov 1;8(11):1616-1623. doi: 10.1001/jamaoncol.2022.4194.
IMPORTANCE
Monitoring of the corrected QT interval (QTc) for patients with cancer receiving chemotherapy is not standardized. Selection of QTc formula may be associated with adverse event grading and chemotherapy delivery.
OBJECTIVE
To describe the association of QTc formula selection with adverse event grading and chemotherapy delivery.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective observational cohort study used data from January 2010 to April 2020 and included adult patients seen at the University of North Carolina Cancer Hospital who had an electrocardiogram (ECG) performed.
EXPOSURES
Adjusted QTc using the Bazett, Fridericia, and Framingham formulae.
MAIN OUTCOMES AND MEASURES
The main outcome was QTc prolongation using the Common Terminology Criteria for Adverse Events (CTCAE). Consistency between formulae was evaluated. Subsequently, appropriateness of clinical management due to prolonged QTc was assessed for a subset of patients being treated with chemotherapy agents associated with a prolonged QT interval. We hypothesized that use of the Bazett formula would be associated with higher rates of QTc prolongation and inappropriate modifications to chemotherapy.
RESULTS
A total of 19 955 ECGs from 6881 adult patients (3055 [44.4%] women, 3826 [55.6%] men; median [IQR] age at first ECG, 60 [47-68] years) were analyzed. The percentage of ECGs with grade 3 QTc prolongation differed by formula (all patients: Framingham, 1.8%; Fridericia, 2.8%; and Bazett, 9.0%; patients receiving QT-prolonging chemotherapy [2340 ECGs]: Framingham, 2.7%; Fridericia, 4.5%; and Bazett, 12.5%). The Bazett formula resulted in a median QTc value 26.4 milliseconds higher than Fridericia and 27.8 milliseconds higher than Framingham. Of the 1786 ECGs classified as grade 3 by Bazett, 1446 (81.0%) were grade 2 or less by either Fridericia or Framingham. A total of 5 of 28 (17.9%) evaluated clinical changes associated with prolonged QTc were deemed inappropriate when using either Fridericia or Framingham formula.
CONCLUSIONS AND RELEVANCE
Findings of this cohort study suggest that the Bazett formula resulted in higher QTc values associated with a 3-fold increase in grade 3 CTCAE toxic effects compared with other common formulae. Use of the Bazett formula likely was associated with inappropriate changes in clinical management. These data support the use of a standard QTc formula (such as Fridericia or Framingham) for QTc correction in oncology.
重要性
监测接受化疗的癌症患者的校正 QT 间期（QTc）尚未标准化。QTc 公式的选择可能与不良事件分级和化疗给药有关。
目的
描述 QTc 公式选择与不良事件分级和化疗给药的关系。
设计、设置和参与者：这项回顾性观察队列研究使用了 2010 年 1 月至 2020 年 4 月的数据，纳入了在北卡罗来纳大学癌症医院就诊的成年患者，这些患者接受了心电图（ECG）检查。
暴露
使用 Bazett、Fridericia 和 Framingham 公式进行校正的 QTc。
主要结局和测量指标
主要结局是使用常见不良事件术语标准（CTCAE）进行的 QTc 延长。评估了公式之间的一致性。随后，对接受与 QT 间期延长相关的化疗药物治疗的部分患者的 QTc 延长的临床管理进行了评估。我们假设使用 Bazett 公式与 QTc 延长和化疗不适当修改的发生率更高有关。
结果
共分析了 6881 例成年患者的 19955 份心电图（3055[44.4%]例女性，3826[55.6%]例男性；首次心电图时的中位[IQR]年龄为 60[47-68]岁）。不同公式的心电图出现 3 级 QTc 延长的百分比不同（所有患者：Framingham，1.8%；Fridericia，2.8%；Bazett，9.0%；接受 QT 延长化疗的患者[2340 份心电图]：Framingham，2.7%；Fridericia，4.5%；Bazett，12.5%）。Bazett 公式得出的 QTc 值中位数比 Fridericia 高 26.4 毫秒，比 Framingham 高 27.8 毫秒。在 Bazett 分类为 3 级的 1786 份心电图中，有 1446 份（81.0%）通过 Fridericia 或 Framingham 分类为 2 级或更低。总共 28 个与延长 QTc 相关的临床变化中有 5 个（17.9%）被认为使用 Fridericia 或 Framingham 公式不适当。
结论和相关性
这项队列研究的结果表明，与其他常见公式相比，Bazett 公式导致的 QTc 值更高，与 3 级 CTCAE 毒性作用的发生率增加了 3 倍。Bazett 公式的使用可能与临床管理的不适当改变有关。这些数据支持在肿瘤学中使用标准的 QTc 公式（如 Fridericia 或 Framingham）进行 QTc 校正。
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