Early Detection of Cardiotoxicity from Systemic and Radiation Therapy in Breast Cancer Patients (CardioTox Breast): Protocol Design of a Multi-Institutional Prospective Study (Preprint)

2021 ◽  
Author(s):  
Giulia Borgonovo ◽  
Elen Vettus ◽  
Alessandra Greco ◽  
Laura Anna Leo ◽  
Francesco Faletra ◽  
...  

BACKGROUND Incidence of breast cancer is rising worldwide. Recent advances in systemic and local treatments have significantly improved survival rates of early breast cancer patients. In the last decade, great attention has been paid to prevention and early detection of cardiotoxicity induced by breast cancer treatments. Systemic therapy-related cardiac toxicities have been extensively studied. Radiotherapy, an essential component of breast cancer treatment, can also increase the risk of heart diseases. Consequently, it is important to balance the expected benefits of cancer treatment with cardiovascular risk and to identify strategies to prevent cardiotoxicity and improve long-term outcomes and quality of life for these patients. OBJECTIVE The Cardiotox study aims to investigate the use of cardiac magnetic resonance imaging and identify associated circulating biomarkers to assess early tissue changes in chemo- and radiation-induced cardiotoxicity in the time window of 12 months after the end of radiotherapy in breast cancer patients. METHODS The Cardiotox Breast trial is a multicenter, observational prospective longitudinal study. The aim is to identify any change in circulating biomarkers and cardiac imaging (based on cardiovascular magnetic resonance and echocardiography), to predict the incidence of cardiotoxicity and to detect it when is still subclinical and reversible. We plan to enrol 150 women with stage I-III, unilateral, breast cancer treated with breast conserving surgery and planned to receive radiotherapy with or without systemic therapy. RESULTS This study details the protocol of the CardioTox Breast trial. As of September 2020, thirteen patients have been enrolled by the Oncology Institute of Southern Switzerland and 4 patients by Fondazione IRCCS Policlinico San Matteo, Italy. Results of the present study will not be published until data are mature for the final analysis of the primary study endpoint. CONCLUSIONS The CardioTox Breast study is designed to investigate the effects of systemic and radiation therapy on myocardial function and structure, thus providing additional evidence on whether CMR is the optimal screening imaging for cardiotoxicity. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT04790266

Author(s):  
Perrine Vuagnat ◽  
Maxime Frelaut ◽  
Toulsie Ramtohul ◽  
Clémence Basse ◽  
Sarah Diakite ◽  
...  

AbstractBackgroundCancer patients have been reported to be at higher risk of COVID-19 complications and deaths. We report the characteristics and outcome of patients diagnosed with COVID-19 during breast cancer treatment at Institut Curie hospitals (ICH, Paris area, France).MethodsAn IRB-approved prospective registry was set up at ICH for all breast cancer patients with COVID-19 symptoms or radiologic signs.ResultsAmong 15,600 patients actively treated for early or metastatic breast cancer during the last 4 months at ICH, 76 patients with suspected COVID-19 infection were included in the registry and followed. Fifty-nine of these patients were diagnosed with COVID-19 based on viral RNA testing or typical radiologic signs: 37/59 (63%) COVID-19 patients were treated for metastatic breast cancer, and 13/59 (22%) of them were taking corticosteroids daily. Common clinical features mostly consisted of fever and/or cough, while ground-glass opacities were the most common radiologic sign at diagnosis. We found no association between prior radiation therapy fields or extent of radiation therapy sequelae and extent of COVID-19 lung lesions. Twenty-eight of these 59 patients (47%) were hospitalized and 6 (10%) were transferred to an intensive care unit. At the time of analysis, 45/59 (76%) patients were recovering or had been cured, 10/59 (17%) were still followed and 4/59 (7%) had died from COVID-19. All 4 patients who died had significant non-cancer comorbidities. In univariate analysis, hypertension and age (>70) were the two factors associated with a higher risk of intensive care unit admission and/or death.ConclusionsThis prospective registry analysis suggests that the COVID-19 mortality rate in breast cancer patients depends more on comorbidities than prior radiation therapy or current anti-cancer treatment. Special attention must be paid to comorbidities when estimating the risk of severe SARS-CoV-2 infection in breast cancer patients.


2018 ◽  
Vol 13 (1) ◽  
Author(s):  
Yan Lin ◽  
Michael C. Wimberly ◽  
Patricia Da Rosa ◽  
Joseph Hoover ◽  
William F. Athas

Few studies of breast cancer treatment have focused on the Northern Plains of the United States, an area with a high mastectomy rate. This study examined the association between geographic access to radiation therapy facilities and receipt of breast cancer treatments among early-stage breast cancer patients in South Dakota. Based on 4,209 early-stage breast cancer patients diagnosed between 2001 and 2012 in South Dakota, the study measured geographic proximity to radiation therapy facilities using the shortest travel time for patients to the closest radiation therapy facility. Two-level logistic regression models were used to estimate for early stage cases i) the odds of mastectomy versus breast conserving surgery (BCS); ii) the odds of not receiving radiation therapy after BCS versus receiving follow-up radiation therapy. Covariates included race/ethnicity, age at diagnosis, tumour grade, tumour sequence, year of diagnosis, census tract-level poverty rate and urban/rural residence. The spatial scan statistic method was used to identify geographic areas with significantly higher likelihood of experiencing mastectomy. The study found that geographic accessibility to radiation therapy facilities was negatively associated with the likelihood of receiving mastectomy after adjustment for other covariates, but not associated with radiation therapy use among patients receiving BCS. Compared with patients travelling less than 30 minutes to a radiation therapy facility, patients travelling more than 90 minutes were about 1.5 times more likely to receive mastectomy (odds ratio, 1.51; 95% confidence interval, 1.08-2.11) and patients travelling more than 120 minutes were 1.7 times more likely to receive mastectomy (odds ratio, 1.70; 95% confidence interval, 1.19-2.42). The study also identified a statistically significant cluster of patients receiving mastectomy who were located in south-eastern South Dakota, after adjustment for other factors. Because geographic proximity to treatment facilities plays an important role on the treatment for early-stage breast cancer patients, this study has important implications for developing targeted intervention to reduce disparities in breast cancer treatment in South Dakota.


Sign in / Sign up

Export Citation Format

Share Document