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Abstract：
BACKGROUND: Myocardial infarction is a cardiac adverse event associated with 5-fluorouracil (5-FU). There are limited data on the incidence, risk, and prognosis of 5-FU-associated myocardial infarction.
OBJECTIVE: The aim of this study was to examine the risk for myocardial infarction in patients with gastrointestinal (GI) cancer treated with 5-FU compared with age- and sex-matched population control subjects without cancer (1:2 ratio).
METHODS: Patients with GI cancer treated with 5-FU between 2004 and 2016 were identified within the Danish National Patient Registry. Prevalent ischemic heart disease in both groups was excluded. Cumulative incidences were calculated, and multivariable regression and competing risk analyses were performed.
RESULTS: A total of 30,870 patients were included in the final analysis, of whom 10,290 had GI cancer and were treated with 5-FU and 20,580 were population control subjects without cancer. Differences in comorbid conditions and select antianginal medications were nonsignificant (P > 0.05 for all). The 6-month cumulative incidence of myocardial infarction was significantly higher for 5-FU patients at 0.7% (95% CI: 0.5%-0.9%) versus 0.3% (95% CI: 0.3%-0.4%) in population control subjects, with a competing risk for death of 12.1% versus 0.6%. The 1-year cumulative incidence of myocardial infarction for 5-FU patients was 0.9% (95% CI: 0.7%-1.0%) versus 0.6% (95% CI: 0.5%-0.7%) among population control subjects, with a competing risk for death of 26.5% versus 1.4%. When accounting for competing risks, the corresponding subdistribution hazard ratios suggested an increased risk for myocardial infarction in 5-FU patients, compared with control subjects, at both 6 months (hazard ratio: 2.10; 95% CI: 1.50-2.95; P < 0.001) and 12 months (hazard ratio: 1.39; 95% CI: 1.05-1.84; P = 0.022).
CONCLUSIONS: Despite a statistically significantly higher 6- and 12-month risk for myocardial infarction among 5-FU patients compared with population control subjects, the absolute risk for myocardial infarction was low, and the clinical significance of these differences appears to be limited in the context of the significant competing risk for death in this population.
OBJECTIVE: The aim of this study was to examine the risk for myocardial infarction in patients with gastrointestinal (GI) cancer treated with 5-FU compared with age- and sex-matched population control subjects without cancer (1:2 ratio).
METHODS: Patients with GI cancer treated with 5-FU between 2004 and 2016 were identified within the Danish National Patient Registry. Prevalent ischemic heart disease in both groups was excluded. Cumulative incidences were calculated, and multivariable regression and competing risk analyses were performed.
RESULTS: A total of 30,870 patients were included in the final analysis, of whom 10,290 had GI cancer and were treated with 5-FU and 20,580 were population control subjects without cancer. Differences in comorbid conditions and select antianginal medications were nonsignificant (P > 0.05 for all). The 6-month cumulative incidence of myocardial infarction was significantly higher for 5-FU patients at 0.7% (95% CI: 0.5%-0.9%) versus 0.3% (95% CI: 0.3%-0.4%) in population control subjects, with a competing risk for death of 12.1% versus 0.6%. The 1-year cumulative incidence of myocardial infarction for 5-FU patients was 0.9% (95% CI: 0.7%-1.0%) versus 0.6% (95% CI: 0.5%-0.7%) among population control subjects, with a competing risk for death of 26.5% versus 1.4%. When accounting for competing risks, the corresponding subdistribution hazard ratios suggested an increased risk for myocardial infarction in 5-FU patients, compared with control subjects, at both 6 months (hazard ratio: 2.10; 95% CI: 1.50-2.95; P < 0.001) and 12 months (hazard ratio: 1.39; 95% CI: 1.05-1.84; P = 0.022).
CONCLUSIONS: Despite a statistically significantly higher 6- and 12-month risk for myocardial infarction among 5-FU patients compared with population control subjects, the absolute risk for myocardial infarction was low, and the clinical significance of these differences appears to be limited in the context of the significant competing risk for death in this population.
摘要：
背景：心肌梗死是与5-氟尿嘧啶（5-FU）相关的心脏不良事件。关于发病率的数据有限，风险，5-FU相关心肌梗死的预后。
目的：本研究的目的是研究接受5-FU治疗的胃肠道（GI）癌症患者与年龄和性别相匹配的无癌症对照受试者（比例为1:2）发生心肌梗死的风险。
方法：在2004年至2016年期间使用5-FU治疗的胃肠道癌症患者在丹麦国家患者注册中心进行了鉴定。排除两组中常见的缺血性心脏病。计算了累积发生率，进行多元回归和竞争风险分析.
结果：共有30,870名患者被纳入最终分析，其中10,290人患有胃肠道癌症，接受5-FU治疗，20,580人是没有癌症的人口对照组。共病条件和选择抗心绞痛药物的差异无统计学意义（均P>0.05）。5-FU患者的6个月累积心肌梗死发生率为0.7％（95％CI：0.5％-0.9％），而人口对照组为0.3％（95％CI：0.3％-0.4％），死亡的竞争风险为12.1%和0.6%。5-FU患者的1年累积心肌梗死发生率为0.9%（95%CI：0.7%-1.0%），而人口对照组为0.6%（95%CI：0.5%-0.7%），死亡的竞争风险为26.5%和1.4%。在考虑竞争风险时，相应的亚分布风险比提示5-FU患者心肌梗死风险增加，与对照组相比，在6个月（风险比：2.10;95％CI：1.50-2.95;P<0.001）和12个月（风险比：1.39;95％CI：1.05-1.84;P=0.022）。
结论：尽管与人群对照组相比，5-FU患者的6个月和12个月心肌梗死风险在统计学上明显更高，心肌梗死的绝对风险较低,这些差异的临床意义在这一人群中显著的死亡竞争风险的背景下似乎是有限的.
目的：本研究的目的是研究接受5-FU治疗的胃肠道（GI）癌症患者与年龄和性别相匹配的无癌症对照受试者（比例为1:2）发生心肌梗死的风险。
方法：在2004年至2016年期间使用5-FU治疗的胃肠道癌症患者在丹麦国家患者注册中心进行了鉴定。排除两组中常见的缺血性心脏病。计算了累积发生率，进行多元回归和竞争风险分析.
结果：共有30,870名患者被纳入最终分析，其中10,290人患有胃肠道癌症，接受5-FU治疗，20,580人是没有癌症的人口对照组。共病条件和选择抗心绞痛药物的差异无统计学意义（均P>0.05）。5-FU患者的6个月累积心肌梗死发生率为0.7％（95％CI：0.5％-0.9％），而人口对照组为0.3％（95％CI：0.3％-0.4％），死亡的竞争风险为12.1%和0.6%。5-FU患者的1年累积心肌梗死发生率为0.9%（95%CI：0.7%-1.0%），而人口对照组为0.6%（95%CI：0.5%-0.7%），死亡的竞争风险为26.5%和1.4%。在考虑竞争风险时，相应的亚分布风险比提示5-FU患者心肌梗死风险增加，与对照组相比，在6个月（风险比：2.10;95％CI：1.50-2.95;P<0.001）和12个月（风险比：1.39;95％CI：1.05-1.84;P=0.022）。
结论：尽管与人群对照组相比，5-FU患者的6个月和12个月心肌梗死风险在统计学上明显更高，心肌梗死的绝对风险较低,这些差异的临床意义在这一人群中显著的死亡竞争风险的背景下似乎是有限的.
