Risk of heart failure in breast cancer patients after anthracycline and trastuzumab treatment: a retrospective cohort study.
Risk of heart failure in breast cancer patients after anthracycline and trastuzumab treatment: a retrospective cohort study.
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DOI：
10.1093/jnci/djs317
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发表时间：
2012-09-05
期刊：
影响因子：
--
通讯作者：
Pharmacovigilance Study Team
中科院分区：
文献类型：
--
作者：
Bowles EJ;Wellman R;Feigelson HS;Onitilo AA;Freedman AN;Delate T;Allen LA;Nekhlyudov L;Goddard KA;Davis RL;Habel LA;Yood MU;McCarty C;Magid DJ;Wagner EH;Pharmacovigilance Study Team
临床试验表明，接受蒽环类药物或曲妥珠单抗治疗乳腺癌的女性患心力衰竭和/或心肌病 (HF/CM) 的风险增加，但这些发现的普遍性尚不清楚。我们估计了现实世界辅助蒽环类药物和曲妥珠单抗的使用及其与心衰/CM 事件的关联。我们对 1999 年 1 月 1 日至 2007 年 12 月 31 日期间在八个综合癌症研究网络卫生系统中被诊断患有侵袭性乳腺癌的 12 500 名女性进行了一项以人群为基础的回顾性队列研究。使用行政程序和药房代码，我们确定了蒽环类药物、曲妥珠单抗和其他化疗药物的使用。我们确定了化疗开始后的 HF/CM 事件，并评估了随时间变化的化疗暴露与未化疗相比的 HF/CM 风险。使用多变量 Cox 比例风险回归模型来估计风险比 (HR) 和 95% 置信区间 (CI)，并根据诊断年龄、分期、癌症研究网络站点、诊断年份、放射治疗和合并症进行调整。 在 12500 名女性中（平均年龄 = 60 岁，范围 = 22-99 岁），29.6% 接受单独蒽环类药物治疗，0.9% 接受单独曲妥珠单抗治疗，3.5% 接受蒽环类药物联合曲妥珠单抗治疗，19.5% 接受其他化疗，46.5% 未接受化疗。接受蒽环类药物和曲妥珠单抗治疗的患者比接受其他化疗或没有接受其他化疗的患者更年轻，合并症更少。与未接受化疗相比，单独接受蒽环类药物治疗的患者发生心衰/CM的风险较高（调整后HR = 1.40，95% CI = 1.11至1.76），尽管增加的风险与其他化疗相似（调整后HR = 1.49，95% CI = 1.25至1.77）；单独使用曲妥珠单抗（调整后的 HR = 4.12，95% CI = 2.30 至 7.42）或蒽环类药物联合曲妥珠单抗（调整后的 HR = 7.19，95% CI = 5.00 至 10.35）治疗的患者的风险显着增加。蒽环类药物和曲妥珠单抗主要用于年轻、健康的女性，与不化疗相比，与心衰/CM 风险增加相关。这项基于人群的观察性研究补充了癌症治疗安全性临床试验的结果。
Clinical trials demonstrated that women treated for breast cancer with anthracycline or trastuzumab are at increased risk for heart failure and/or cardiomyopathy (HF/CM), but the generalizability of these findings is unknown. We estimated real-world adjuvant anthracycline and trastuzumab use and their associations with incident HF/CM. We conducted a population-based, retrospective cohort study of 12 500 women diagnosed with incident, invasive breast cancer from January 1, 1999 through December 31, 2007, at eight integrated Cancer Research Network health systems. Using administrative procedure and pharmacy codes, we identified anthracycline, trastuzumab, and other chemotherapy use. We identified incident HF/CM following chemotherapy initiation and assessed risk of HF/CM with time-varying chemotherapy exposures vs no chemotherapy. Multivariable Cox proportional hazards regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) with adjustment for age at diagnosis, stage, Cancer Research Network site, year of diagnosis, radiation therapy, and comorbidities. Among 12 500 women (mean age = 60 years, range = 22–99 years), 29.6% received anthracycline alone, 0.9% received trastuzumab alone, 3.5% received anthracycline plus trastuzumab, 19.5% received other chemotherapy, and 46.5% received no chemotherapy. Anthracycline and trastuzumab recipients were younger, with fewer comorbidities than recipients of other chemotherapy or none. Compared with no chemotherapy, the risk of HF/CM was higher in patients treated with anthracycline alone (adjusted HR = 1.40, 95% CI = 1.11 to 1.76), although the increased risk was similar to other chemotherapy (adjusted HR = 1.49, 95% CI = 1.25 to 1.77); the risk was highly increased in patients treated with trastuzumab alone (adjusted HR = 4.12, 95% CI = 2.30 to 7.42) or anthracycline plus trastuzumab (adjusted HR = 7.19, 95% CI = 5.00 to 10.35). Anthracycline and trastuzumab were primarily used in younger, healthier women and associated with increased HF/CM risk compared with no chemotherapy. This population-based observational study complements findings from clinical trials on cancer treatment safety.
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影响因子：
7.2
作者：
DEYO, RA;CHERKIN, DC;CIOL, MA
通讯作者：
CIOL, MA
影响因子：
45.3
作者：
Perez, Edith A.;Romond, Edward H.;Wolmark, Norman
通讯作者：
Wolmark, Norman
影响因子：
45.3
作者：
Guarneri, Valentina;Lenihan, Daniel J.;Esteva, Francisco J.
通讯作者：
Esteva, Francisco J.
影响因子：
2.6
作者：
Mackey, J. R.;Clemons, M.;Verma, S.
通讯作者：
Verma, S.
DOI：
10.1136/bmj.d1828
发表时间：
2011-04-05
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Blümle A;Meerpohl JJ;Rücker G;Antes G;Schumacher M;von Elm E
通讯作者：
von Elm E