QTc Interval-Prolonging Medications Among Patients With Lung Cancer: Implications for Clinical Trial Eligibility and Clinical Care
QTc Interval-Prolonging Medications Among Patients With Lung Cancer: Implications for Clinical Trial Eligibility and Clinical Care
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DOI：
10.1016/j.cllc.2019.07.008
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发表时间：
2020-01-01
影响因子：
3.6
通讯作者：
Gerber, David E.
中科院分区：
文献类型：
--
作者：
Tri Le;Yang, Hui;Gerber, David E.
使用校正 QT (QTc) 间期延长药物是临床试验中常见的排除标准。为了探索其潜在效果，对退伍军人事务系统中的一组肺癌患者进行了研究，以确定此类药物的流行率。在 280,068 名患者中，28.4% 的患者服用了 >= 1 QTc 间期延长药物，7.3% 的患者服用了 >= 2 的 QTc 间期延长药物，需要进一步研究癌症人群 QTc 间期延长药物的实际临床风险和最佳管理。 背景：同时使用药物，包括延长校正 QT (QTc) 间期的药物，可能会导致癌症患者被排除在临床试验之外。为了估计对应计费用的潜在影响，我们确定了全国患者队列中延长 QTc 的药物处方的流行率。患者和方法：我们确定了退伍军人事务系统中 2003 年至 2016 年诊断为肺癌的成年患者。QTc 间期延长药物的使用情况和风险类别来自 CredibleMeds。我们计算了癌症诊断日期（含）之前 3 个月内已知或可能存在尖端扭转型室性心动过速风险的延长 QTc 的药物处方的流行率。使用chi(2)检验比较不同患者组的比率。结果：本研究共纳入 280,068 名患者。平均年龄为 70 岁，98% 为男性，72% 为白人。总体而言，28.4% 的患者服用了延长 QTc 的药物，7.3% 的患者在癌症诊断前 3 个月内服用了≥2 种药物。最常用的延长 QTc 的药物是抗菌药物 (14.0%)、精神药物 (10.2%)、止吐药物 (2.6%) 和心脏药物 (1.7%)。不包括抗菌药物，18.4% 的患者服用了延长 QTc 的药物。结论：很大一部分肺癌患者将接受延长 QTc 的药物治疗。这些处方可能会限制患者参加临床试验的资格，并使标准癌症治疗的实施变得复杂。有必要进一步研究癌症人群中 QTc 延长药物的实际临床风险和最佳管理。 (C) 2019 Elsevier Inc. 保留所有权利。
The use of corrected QT (QTc) interval-prolonging medications is a common exclusion criterion in clinical trials. To explore its potential effect, a cohort of patients with lung cancer in the Veterans Affairs system was studied to determine the prevalence of such drugs. Among 280,068 patients, 28.4% had been prescribed >= 1 QTc-interval prolonging medication, and 7.3% had been prescribed >= 2, warranting further research into the actual clinical risks and optimal management of QTc-prolonging medications in populations with cancer.Background: Concomitant medication use, including agents that prolong the corrected QT (QTc) interval, can result in t he exclusion of patients with cancer from clinical trials. To estimate the potential effects on accrual, we determined t he prevalence of QTc-prolonging medication prescriptions in a national patient cohort. Patients and Methods: We identified adult patients in the Veterans Affairs system with a diagnosis of lung cancer from 2003 to 2016. The use of QTc interval-prolonging medications and risk category were obtained from CredibleMeds. We calculated the preval ence of prescriptions for QTc-prolonging medications with a known or possible risk of torsade de pointes in the 3 months up to and including the date of cancer diagnosis. The rates across patient groups were compared using chi(2) test. Results: A total of 280,068 patients were included in the present study. The mean age was 70 years, 98% were male, and 72% were white. Overall, 28.4% had been prescribed a QTc-prolonging medication, and 7.3% had been prescribed >= 2 in the 3 months before the cancer diagnosis. The most commonly prescribed QTc-prolonging medications were antimicrobial agents (14.0%), psychiatric agents (10.2%), antiemetic agents (2.6%), and cardiac medications (1.7%). Excluding the antimicrobial agents, 18.4% of the patients had been prescribed a QTc-prolonging medication. Conclusions: A substantial proportion of individuals with lung cancer will be prescribed QTc-prolonging medications. These prescriptions can limit patients' eligibility for clinical trials and complicate the administration of standard cancer therapies. Further research into the actual clinical risks and optimal management of QTc-prolonging medications in cancer populations is warranted. (C) 2019 Elsevier Inc. All rights reserved.