Risk of heart failure after systemic treatment for early breast cancer: results of a cohort study

Jacobse, Judy N.; Schaapveld, Michael; Boekel, Naomi B.; Hooning, Maartje J.; Jager, Agnes; Baaijens, Margreet H.A.; Hauptmann, Michael; Russell, Nicola S.; Rutgers, Emiel J.; Aleman, Berthe M.P.; Sonke, Gabe S.; Leeuwen, Flora E. van

doi:10.1007/s10549-020-05930-w

Cited by 24 publications

(40 citation statements)

References 30 publications

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“…These results are consistent with those reported by a meta-analysis of eight RCTs comparing upfront adjuvant aromatase inhibitors to tamoxifen, which showed a 19% (7–34%) increased risk of CV events in women treated with aromatase inhibitors, as well as with those of other “real life” registers reported in the recent literature [ 25 ]. A recent study conducted in the UK showed that breast cancer women without previous CV diseases treated with aromatase inhibitors had higher risk of heart failure (HR = 2.80, 1.29 to 6.08) than those treated with tamoxifen.…”

Section: Discussionsupporting

confidence: 92%

Adjuvant Hormonotherapy and Cardiovascular Risk in Post-Menopausal Women with Breast Cancer: A Large Population-Based Cohort Study

Franchi

Tritto

Tarantini

et al. 2021

Cancers

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Background: Whether aromatase inhibitors (AIs) increase the risk of cardiovascular (CV) events, compared to tamoxifen, in women with breast cancer is still debated. We evaluated the association between AI and CV outcomes in a large population-based cohort of breast cancer women. Methods: By using healthcare utilization databases of Lombardy (Italy), we identified women ≥50 years, with new diagnosis of breast cancer between 2009 and 2015, who started adjuvant therapy with either AI or tamoxifen. We estimated the association between exposure to AI and CV outcomes (including myocardial infarction, ischemic stroke, heart failure or any CV event) by a Cox proportional hazard model with inverse probability of treatment and censoring weighting. Results: The study cohort included 26,009 women starting treatment with AI and 7937 with tamoxifen. Over a median follow-up of 5.8 years, a positive association was found between AI and heart failure (Hazard Ratio = 1.20, 95% CI: 1.02 to 1.42) and any CV event (1.14, 1.00 to 1.29). The CV risk increased in women with previous CV risk factors, including hypertension, diabetes and dyslipidemia. Conclusions: Adjuvant therapy with AI in breast cancer women aged more than 50 years is associated with increased risk of heart failure and combined CV events.

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Section: Discussionsupporting

confidence: 92%

Adjuvant Hormonotherapy and Cardiovascular Risk in Post-Menopausal Women with Breast Cancer: A Large Population-Based Cohort Study

Franchi

Tritto

Tarantini

et al. 2021

Cancers

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“…Reversibility of cardiac toxicity in our patients was lower than reported in the adjuvant trastuzumab trials [ [1] , [2] , [3] , [4] ]. The principal explanation for this discrepancy could rely on slight inconsistency in the definition of cardiac recovery in the medical literature, as consensus on the definition for cardiotoxicity is still lacking [ [11] , [12] , [13] ]. The adjuvant trastuzumab trials themselves used slightly different definitions of cardiac recovery [ 3 , 14 , 15 ].…”

Section: Discussionmentioning

confidence: 99%

“…As a matter of fact, the proportion of patients who recovered in our study is closer to the one described in the real-world study OHERA (67.3%; “patients with significant LVEF drop who achieved resolution” in Table 2 ). Furthermore, a recent cohort study reported that one-third of the population who developed cardiac toxicity after trastuzumab had long-term impaired cardiac function [ 12 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical predictors of cardiac toxicity in HER2-positive early breast cancer patients treated with adjuvant s.c. versus i.v. trastuzumab

et al. 2021

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Background Few data are available about real-life cardiotoxicity associated with s.c. versus i.v. trastuzumab treatment of early-stage, HER2-positive breast cancer, and little is known about its predisposing factors. Patients and methods We retrospectively reviewed data of 363 adult patients treated with adjuvant trastuzumab for HER2-positive breast cancer. Univariate statistical analysis was performed, and a multivariable logistic model was developed to identify independent risk factors of cardiac toxicity. Results Within 5 years, the overall incidence of events meeting our criteria was 11.8%, and an early discontinuation of trastuzumab was recorded in 20 patients (5.5%). No cases of congestive heart failure occurred, neither multiple events per patient were observed. A total of 184 patients received i.v. and 179 received s.c. trastuzumab. Compared with the s.c. formulation, a higher cardiotoxicity rate for the i.v. administration (15.2% vs 8.4%) was found, and particularly in those patients with cardiovascular risk factors (19.3% vs 8.7%), at the univariate and multivariate analyses. Although more patients with prior anthracycline-based chemotherapy experienced cardiac events, the association of this therapy with cardiac events was not significant. The incidence of cardiac events was not influenced by anthropometric data (e.g. body mass index) or a diagnosis of diabetes mellitus. 5-year event-free survival was 91.7% in the overall population; event-free survival rates were similar between the s.c. and the i.v. groups. Conclusion Our study shows a more favorable safety profile of s.c. versus i.v trastuzumab administration. The use of s.c. trastuzumab could be advisable in at-risk patients.

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“…In the analysis with tamoxifen exposure as comparator, AI exposure was associated with increased risk for coronary artery disease, arrhythmias, and heart failure, whereas this relationship was diminished when no endocrine therapy was used as comparator [14]. On the other hand, Jacobse et al investigated the risk for heart failure in a population-based cohort of 10 209 breast cancer patients and found that AI exposure was associated with increased risk for heart failure compared to no endocrine therapy [12]. Our results, showing lack of association between AI exposure and CVD outcomes in the analysis including the whole study cohort, are consistent with most of the previously published observational studies comparing AI with no endocrine treatment [12e14].…”

Section: Discussionmentioning

confidence: 99%

“…Meta-analyses of RCTs investigating toxicity of extended adjuvant AI compared with no treatment have shown conflicting results with increased risk for CVD with AIs in one [ 9 ], but no difference in two other meta-analyses [ 10 , 11 ]. Regarding real-world evidence on CVD risk due to AIs compared to patients without endocrine therapy, few studies are published so far, with conflicting evidence [ [12] , [13] , [14] ].…”

Section: Introductionmentioning

confidence: 99%

Aromatase inhibitors use and risk for cardiovascular disease in breast cancer patients: A population-based cohort study

et al. 2021

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Background: Prior studies regarding use of Aromatase inhibitors (AIs) and risk for cardiovascular disease (CVD) have shown conflicting results. This retrospective cohort study aimed to investigate whether AIs use affects risk for CVD events in postmenopausal breast cancer survivors. Methods: Using a retrospective cohort study design, four CVD outcomes; heart failure or cardiomyopathy, arrhythmia, acute ischemic heart disease and ischemic stroke or Transient Ischemic Attack were compared with uni-and multivariate Cox regression analyses according to exposure to endocrine therapy (use of AI, tamoxifen or AI/tamoxifen sequentially) or no endocrine therapy. Results: In total 15815 postmenopausal women, surgically treated to early breast cancer during 2006 e2012, were included. No significantly increased risk for CVD events was observed in patients with AI use in the whole cohort. However, two subgroup analyses showed increased risk for CVD events in the AI/tamoxifen sequential group; heart failure in patients older than 75 years (Hazard Ratio (HR) 2.44; 95% Confidence Interval (CI): 1.32e4.54) and arrhythmia in patients without prior CVD (HR 1.45; 95% CI: 1.01 e2.10). An increased risk for arrhythmia and acute ischemic heart disease in patients with at least four years of AI treatment compared with no or short-time exposure was observed (HR 2.12; 95% CI: 1.40 e3.25 for arrhythmia; HR 2.03; 95% CI: 1.15e3.58 for ischemic heart disease). Conclusion:Our results indicate an increased risk for ischemic heart disease and arrhythmia in patients treated for more than four years with AIs. This should be considered in the risk-benefit assessment concerning endocrine therapy.

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Risk of heart failure after systemic treatment for early breast cancer: results of a cohort study

Cited by 24 publications

References 30 publications

Adjuvant Hormonotherapy and Cardiovascular Risk in Post-Menopausal Women with Breast Cancer: A Large Population-Based Cohort Study

Adjuvant Hormonotherapy and Cardiovascular Risk in Post-Menopausal Women with Breast Cancer: A Large Population-Based Cohort Study

Clinical predictors of cardiac toxicity in HER2-positive early breast cancer patients treated with adjuvant s.c. versus i.v. trastuzumab

Aromatase inhibitors use and risk for cardiovascular disease in breast cancer patients: A population-based cohort study

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