Attenuating treatment-related toxicity in women recently diagnosed with breast cancer via a tailored physical exercise program using a mobile app “ATOPE+”: Protocol of the ATOPE trial. (Preprint)

2020 ◽  
Author(s):  
Paula Postigo-Martin ◽  
Rafael Peñafiel-Burkhardt ◽  
Tania Gallart-Aragón ◽  
Miriam Alcaide-Lucena ◽  
Francisco Artacho-Cordón ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Left Ventricular Ejection Fraction ◽  
Adverse Effects ◽  
Left Ventricular ◽  
Mobile App ◽  
Left Ventricular Ejection ◽  
Therapeutic Exercise ◽  
Main Trial ◽  
Ventricular Ejection Fraction ◽  
Recovery Strategies

BACKGROUND Therapeutic exercise is already much used as a means of ameliorating some of the side effects of cancer treatment. Recent studies have examined its preventive potential with respect to the appearance of treatment-related toxicity. Toxicity-induced cardiac damage - indeed, even temporary adverse effects on the heart - can increase the risk of functional decline, which can in turn lead to disease recurrence and death. OBJECTIVE The present trial will examine whether the ATOPE (Tailored Therapeutic Exercise and Recovery Strategies) program, performed before treatment starts for recently diagnosed breast cancer (ATOPE-B), can mitigate the onset and extent of cardiotoxicity beyond that achieved when the program is followed by similar patients who have already begun treatment (ATOPE-I), using a mobile app, ATOPE+, to determine women’s therapeutic exercise assimilation. METHODS The ATOPE intervention consists of 6 bouts of general preparatory exercise plus 12-18 bouts of tailored, high intensity exercise (whole-body and locoregional exercises), and the following of post-exercise recovery strategies (stretching and breathing exercises). A total of 120 female patients recently diagnosed with stage 1-IIIb breast cancer and awaiting surgery followed by chemotherapy and/or radiotherapy, and at risk of cardiotoxicity as described by the American Society of Clinical Oncology Guidelines, will be randomised 1:1 to either ATOPE-B or ATOPE-I. In a small feasibility study performed before the main trial, and lasting one full cycle of the ATOPE program, measurements related to recruitment rate, satisfaction with the application, satisfaction with the ATOPE-B and ATOPE-I programs, adherence to the program, the retention of subjects, safety, and adverse effects will be explored. In the main trial, which is designed to examine the efficacy of these interventions, the major outcome variable will be cardiotoxicity, assessed echocardiographically via the left ventricular ejection fraction. This, along with other clinical, physical, and anthropometric outcomes, and biological and hormonal variables, will be assessed after diagnosis, 3 days before the third chemotherapy session, 1 year after treatment ends, and 3 years after treatment ends. RESULTS Not aplicable CONCLUSIONS The left ventricular ejection fraction is modified by cancer treatment. Given its potential effect on patient survival, the mitigation of cardiotoxicity is a priority. If the ATOPE-B intervention returns better cardioprotection results than ATOPE-I, it may be recommendable that patients yet to begin treatment for breast cancer, follow this program. CLINICALTRIAL ClinicalTrials.gov, NCT03787966

Attenuating Treatment-Related Cardiotoxicity in Women Recently Diagnosed with Breast Cancer via a Tailored Therapeutic Exercise Program: Protocol of the ATOPE Trial

2021 ◽  
Author(s):  
Paula Postigo-Martin ◽  
Rafael Peñafiel-Burkhardt ◽  
Tania Gallart-Aragón ◽  
Miriam Alcaide-Lucena ◽  
Francisco Artacho-Cordón ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Functional Decline ◽  
Left Ventricular ◽  
Recruitment Rate ◽  
Left Ventricular Ejection ◽  
Therapeutic Exercise ◽  
Breast Cancer Patients ◽  
Main Trial ◽  
Ventricular Ejection Fraction ◽  
Recovery Strategies

Abstract Objective Therapeutic exercise is already used to ameliorate some of the side effects of cancer treatment. Recent studies examined its preventive potential regarding treatment-related toxicity, which can increase the risk of functional decline and lead to disease recurrence and death. This trial will examine whether the ATOPE (Tailored Therapeutic Exercise and Recovery Strategies) program, performed before treatment (ATOPE-B), can mitigate the onset and extent of cardiotoxicity beyond that achieved when the program is followed during treatment (ATOPE-I) in recently diagnosed breast cancer patients. Methods The intervention has a preparatory phase plus 12 to 18 sessions of tailored, high-intensity exercise, and post-exercise recovery strategies. 120 women recently diagnosed with breast cancer, in risk of cardiotoxicity due to anticancer treatment awaiting surgery followed by chemotherapy and/or radiotherapy, will be randomised to either group. In a feasibility study, measurements related to recruitment rate, satisfaction with the program, adherence to them, the retention of subjects, safety, and adverse effects will be explored. In the main trial, the efficacy of these interventions will be examined. The major outcome will be cardiotoxicity, assessed echocardiographically via the left ventricular ejection fraction. Other clinical, physical, anthropometric outcomes, biological and hormonal variables, will be also assessed after diagnosis, after treatment, 1 year after treatment ends, and 3 years after treatment ends. Conclusion Given its potential effect on patient survival, the mitigation of cardiotoxicity is a priority, and physiotherapists have an important role in this mitigation. If the ATOPE-B intervention returns better cardioprotection results, it may be recommendable that patients recently diagnosed follow this program.

Trastuzumab-Associated Cardiac Adverse Effects in the Herceptin Adjuvant Trial

2007 ◽  
Vol 25 (25) ◽  
pp. 3859-3865 ◽  
Author(s):  
Thomas M. Suter ◽  
Marion Procter ◽  
Dirk J. van Veldhuisen ◽  
Michael Muscholl ◽  
Jonas Bergh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Adverse Effects ◽  
Cancer Patients ◽  
Cardiac Dysfunction ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Breast Cancer Patients ◽  
Ventricular Ejection Fraction ◽  
Neo Adjuvant Chemotherapy

Purpose The purpose of this analysis was to investigate trastuzumab-associated cardiac adverse effects in breast cancer patients after completion of (neo)adjuvant chemotherapy with or without radiotherapy. Patients and Methods The Herceptin Adjuvant (HERA) trial is a three-group, multicenter, open-label randomized trial that compared 1 or 2 years of trastuzumab given once every 3 weeks with observation in patients with HER-2–positive breast cancer. Only patients who after completion of (neo)adjuvant chemotherapy with or without radiotherapy had normal left ventricular ejection fraction (LVEF ≥ 55%) were eligible. A repeat LVEF assessment was performed in case of cardiac dysfunction. Results Data were available for 1,693 patients randomly assigned to 1 year trastuzumab and 1,693 patients randomly assigned to observation. The incidence of trastuzumab discontinuation due to cardiac disorders was low (4.3%). The incidence of cardiac end points was higher in the trastuzumab group compared with observation (severe congestive heart failure [CHF], 0.60% v 0.00%; symptomatic CHF, 2.15% v 0.12%; confirmed significant LVEF drops, 3.04% v 0.53%). Most patients with cardiac dysfunction recovered in fewer than 6 months. Patients with trastuzumab-associated cardiac dysfunction were treated with higher cumulative doses of doxorubicin (287 mg/m2 v 257 mg/m2) or epirubicin (480 mg/m2 v 422 mg/m2) and had a lower screening LVEF and a higher body mass index. Conclusion Given the clear benefit in disease-free survival, the low incidence of cardiac adverse events, and the suggestion that cardiac dysfunction might be reversible, adjuvant trastuzumab should be considered for treatment of breast cancer patients who fulfill the HERA trial eligibility criteria.

P6237Clinical utility of echocardiographic left-ventricular ejection fraction monitoring for cardiotoxicity risk assessment in patients with HER2+ early breast cancer undergoing trastuzumab-based therapy

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F Posch ◽  
T Glantschnig ◽  
S Firla ◽  
M Smolle ◽  
M Balic ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Left Ventricular Ejection Fraction ◽  
Ejection Fraction ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
One Year ◽  
Over Time

Abstract Background Monitoring left-ventricular ejection fraction (LVEF) is a routinely-practiced strategy to survey patients with breast cancer (BC) towards cardiotoxic treatment effects. However, whether the LVEF as a single measurement or as a trajectory over time is truly sufficient to identify patients at high risk for cardiotoxicity is currently debated. Purpose To quantify the prognostic impact of LVEF and its change over time for predicting cardiotoxicity in women with HER2+ early BC. Methods We analyzed 1,136 echocardiography reports from 185 HER2+ early BC patients treated with trastuzumab ± chemoimmunoendocrine therapy in the neoadjuvant/adjuvant setting (Table 1). Cardiotoxicity was defined as a 10% decline in LVEF below 50%. Results Median baseline LVEF was 64% (25th-75th percentile: 60–69). Nineteen patients (10%) experienced cardiotoxicity (asymptomatic n=12, symptomatic n=7, during treatment n=19, treatment modification/termination n=14), Median time to cardiotoxicity was 6.7 months, and median LVEF decline in patients with cardiotoxicity was 18%. One-year cardiotoxicity risk was 7.6% in the 35 patients with a baseline LVEF≥60% and 24.5% in the 150 patients with a baseline LVEF<60% (Hazard Ratio (HR)=3.45, 95% CI: 1.35–8.75, Figure 1). During treatment, LVEF declined significantly faster in patients who developed cardiotoxicity than in patients without cardiotoxicity (1.3%/month vs. 0.1%/month, p<0.0001). A higher rate of LVEF decrease predicted for higher cardiotoxicity risk (HR per 0.1%/month higher LVEF decrease/month=2.50, 95% CI: 1.31–4.76, p=0.005), and cardiotoxicity risk increased by a factor of 1.7 per 5% absolute LVEF decline from baseline to first follow-up (HR=1.70, 95% CI: 1.30–2.38, p<0.0001). Thirty-six patients (19%) developed an LVEF decline of at least 5% from baseline to first follow-up (“early LVEF decline”). One-year cardiotoxicity risk was 6.8% in those without early LVEF decline and a baseline LVEF≥60% (n=117), 15.7% in those without an early LVEF decline and a baseline LVEF<60% (n=65), and 66.7% in those with an early LVEF decline and a baseline LVEF<60% (n=3), respectively (log-rank p<0.0001). Table 1. Baseline characteristics Age (years, median [IQR]) 55 [49–65] Estrogen receptor positive (n, %) 124 (67%) Neoadjuvant setting (n, %) 103 (56%) Figure 1. Risk of Cardiotoxicity. Conclusion Both a single LVEF measurement and the rate of LVEF decrease strongly predict cardiotoxicity in early BC patients undergoing HER2-targeted therapy. Routine LVEF monitoring identifies individuals at high risk of cardiotoxicity that may benefit from more sensitive screening techniques such as strain imaging.

A randomized comparison of single-agent doxorubicin and epirubicin as first-line cytotoxic therapy in advanced breast cancer.

1991 ◽  
Vol 9 (12) ◽  
pp. 2148-2152 ◽  
Author(s):  
D J Perez ◽  
V J Harvey ◽  
B A Robinson ◽  
C H Atkinson ◽  
P J Dady ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Left Ventricular Ejection Fraction ◽  
Ejection Fraction ◽  
Advanced Breast Cancer ◽  
Cardiac Failure ◽  
Response Duration ◽  
Left Ventricular ◽  
Advanced Breast ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction

One hundred forty-one patients with advanced breast cancer who had not received prior chemotherapy were randomly assigned to receive doxorubicin 60 mg/m2 or epirubicin 90 mg/m2 every 3 weeks. These doses were selected to produce equivalent toxicities. All patients were assessed for toxicity, and 138 patients were assessable for response. After a median of five treatment cycles, 47% (32 of 68) of doxorubicin-treated patients achieved a partial or complete response. Response duration and survival were 10 and 12 months for doxorubicin and 8 and 10 months for epirubicin, respectively. Noncardiac toxicities were similar for both drugs. Of 41 patients receiving doxorubicin who had serial left ventricular ejection fraction assessments, seven sustained a fall of 10% or more, and one patient developed congestive cardiac failure at a cumulative doxorubicin dose of 489 mg/m2. Of 39 patients receiving epirubicin who had serial cardiac assessments, five sustained left ventricular ejection fraction falls of 10% or more and two patients developed congestive cardiac failure at cumulative doses of 178 mg/m2 and 833 mg/m2. These data indicate that an epirubicin dose of 90 mg/m2 produces toxicity equivalent to doxorubicin 60 mg/m2 but does not improve response rates, response duration, or survival in advanced breast cancer.

Detection of doxorubicin cardiotoxicity in patients with breast cancer by 99mTc-MIBI myocardial perfusion tomography

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10775-10775
Author(s):  
F. Morales-Vasquez ◽  
S. García ◽  
H. Lopez-Basave ◽  
R. Altamirano-Ley
Keyword(s):  
Breast Cancer ◽  
Left Ventricular Ejection Fraction ◽  
Myocardial Perfusion ◽  
Ejection Fraction ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Nuclear Angiography ◽  
99Mtc Mibi ◽  
Myocardial Perfusion Tomography

10775 Background: Cardiotoxicity is a well-known side effect of several cytotoxic drugs especially of the anthracyclines and can lead to long term morbidity. Endomyocardial biopsy is the only specific test for early diagnosis of anthracycline-induce toxicity. Efforts are continuing on finding a more sensitive and reliable predictor of eventual clinic cardiac dysfunction. Therefore, it is crucial that careful monitoring to identify those patients patients who are at risk of developing unpredectible and some times-irreversible dysfunction. Serial measurement of left ventricular ejection fraction by radionuclide angiography remains a useful and widely adopted modality in monitoring patients that are receiving doxorubicin. Objective: To investigate the value of 99mTc-MIBI myocardial perfusion tomography to detect myocardial damage in patients with breast cancer under chemotherapy. Methods: Thirty patients were examined from May to December 2000 by electrocardiogram (ECG), nuclear angiography for detecting left ventricular ejection fraction (LVEF) and 99mTc-MIBI myocardial perfusion was performed before chemotherapy and after chemotherapy. Results: Fifteen patients were treated by continuos infusion over 24 hr, nine patients over 48 hr and 6 patients were treated by bolus. The patients presented with a decrease of > or = 9% in absolute ejection fraction at 200–320 mg/m2 with 99mTc-MIBI and 5% with nuclear angiography. Gated myocardial perfusion scintigraphy results were abnormal in four patients (12.9%). All patients were treated by continuos infusion and the radiotherapy was absent. Other factors were investigated: hypertension, diabetes, smoker and obesity. Conclusions: 99 mTc-MIBI studies are helpful in the assessment of doxorubicin cardiotocixity. Anthracyclines induced myocite injury symptomatic or asymptomatic; uptake at intermediate cumulative doses identifies patients at risk of cardiotoxicity before ejection fraction deteriorates. The 99-mTc-MI BI imaging may be a sensitive method for non invasive visualization of myocardial cell damage and useful in the early diagnosis of specific heart muscle disease. Doxorubicin cause silent myocardial ischemia. No significant financial relationships to disclose.

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