Pfizer Inc, New York, NY, USA.
Pfizer Inc, New York, NY, USA.
Clin Ther. 2019 Mar;41(3):494-504.e1. doi: 10.1016/j.clinthera.2019.01.012. Epub 2019 Feb 18.
In addition to biomarker status, treatment selection for metastatic breast cancer (mBC) includes individual patient and clinical characteristics such as tumor burden, timing of disease recurrence, and comorbidities. Women with mBC may take medications that can increase the risk of drug-induced toxicities, including prolongation of cardiac repolarization (prolongation of QT interval). Corrected QT (QTc) prolongation, a toxicity associated with many cancer treatments, can lead to potentially life-threatening ventricular arrhythmias. As such, it is important to identify patients at risk for QTc prolongation due to comorbid conditions, concomitant medications, or electrolyte abnormalities. This real-world study estimated the proportion of women with hormone receptor‒positive (HR+)/human epidermal growth factor receptor 2‒negative (HER2‒) mBC who may be at risk of developing QTc prolongation. Results in the elderly are also included.
This retrospective, cross-sectional cohort study used the Truven Health MarketScan and Optum Clinformatics administrative claims databases. Patients' medical and pharmacy data were evaluated to assess the risk of QTc prolongation. Prescription and medication administration claims were evaluated during the 7-day period before the index date (ie, first secondary neoplasm diagnosis). In addition, International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification, codes were evaluated 12 months before the index date to describe congenital long QT syndrome, cardiac disease, and electrolyte abnormalities.
A cohort of 24,340 women with HR+/HER2‒ mBC were identified, including 5059 women aged 65-74 years and 4851 aged ≥75 years. Based on an overall analysis of risk factors (congenital long QT syndrome, cardiovascular disease, electrolyte abnormalities, or concomitant medications), 29.5% of all patients, 33.2% of patients aged 65-74 years, and 40.5% of patients aged ≥75 years had risk factors for QTc prolongation.
This analysis of real-world data indicates that almost 1 in 3 women with HR+/HER2‒ mBC had congenital long QT syndrome, cardiovascular disease, and/or electrolyte abnormalities or received a concomitant medication that could increase the risk of developing QTc prolongation. The risk factors for congenital long QT syndrome, cardiovascular disease, or electrolyte abnormalities were more common in older patients. This analysis emphasizes the importance of individualized benefit/risk assessment during treatment decisions, especially when considering drugs with known or possible QTc prolongation risk.
除了生物标志物状态外，转移性乳腺癌（mBC）的治疗选择还包括个体患者和临床特征，如肿瘤负担、疾病复发时间和合并症。患有 mBC 的女性可能会服用一些药物，这些药物会增加药物引起的毒性的风险，包括心脏复极延长（QT 间期延长）。校正的 QT（QTc）延长是许多癌症治疗相关的毒性，可导致潜在的危及生命的室性心律失常。因此，重要的是要识别出由于合并症、伴随用药或电解质异常而有发生 QTc 延长风险的患者。这项真实世界的研究估计了激素受体阳性（HR+）/人表皮生长因子受体 2 阴性（HER2-）mBC 女性中可能有发展为 QTc 延长风险的比例。也包括了老年人的结果。
这是一项回顾性、横断面队列研究，使用了 Truven Health MarketScan 和 Optum Clinformatics 行政索赔数据库。评估了患者的医疗和药物数据，以评估 QTc 延长的风险。在索引日期（即第二次恶性肿瘤诊断的第一天）前 7 天评估处方和药物管理索赔。此外，在索引日期前 12 个月评估了国际疾病分类，第九/第十修订版，临床修正码，以描述先天性长 QT 综合征、心脏病和电解质异常。
确定了 24340 名 HR+/HER2-mBC 女性的队列，其中包括 5059 名 65-74 岁的女性和 4851 名≥75 岁的女性。基于对所有患者（29.5%）、65-74 岁患者（33.2%）和≥75 岁患者（40.5%）的风险因素的总体分析，所有患者中有 29.5%、65-74 岁患者中有 33.2%、75 岁以上患者中有 40.5%存在 QTc 延长的风险因素。
这项真实世界数据的分析表明，几乎每 3 名 HR+/HER2-mBC 女性中就有 1 名患有先天性长 QT 综合征、心血管疾病和/或电解质异常，或接受了可能增加 QTc 延长风险的伴随药物。先天性长 QT 综合征、心血管疾病或电解质异常的风险因素在老年患者中更为常见。这项分析强调了在治疗决策中进行个体化获益/风险评估的重要性，特别是在考虑具有已知或可能导致 QTc 延长风险的药物时。
