Study population
This prospective observational study screened more than 100 breast cancer patients from April 2019 to May 2020 and plans to receive anthracycline chemotherapy at the first affiliated Hospital of Wenzhou Medical University. A detailed questionnaire was gathered, including the presence of clinical history, electrocardiogram, an echocardiogram, and blood sampling, at the recruitment. This study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Wen Zhou Medical University.
Inclusion criteria were: at least 18 years of age; have not received chemotherapy and (or) radiotherapy before; electrocardiogram (ECG), kidney and liver function, blood routine tests were standard; breast cancer was diagnosed by histopathology in our hospital, and at least four cycles of chemotherapy were completed in our hospital.
Exclusion criteria were: pregnant or nursing women; metastatic breast cancer; congenital heart disease; valvular disease; severe arrhythmia; standard echo images of inadequate quality and echocardiographic EF<50% before chemotherapy.
The primary end-point was patients with significant LVEF decline without congestive heart failure symptoms or mild symptoms (NYHA heart function class I), LVEF decreased by at least 10% and LVEF<53%; Patients with symptoms of congestive heart failure (NYHA heart function grade II, III or IV grade), LVEF decreased by at least 5% and LVEF<53%; GLS decreased by more than 15% compared with the baseline value before chemotherapy according to the ASE/EACVI Expert Consensus[13-15].
Finally, 56 patients met the criteria for enrollment. All patients will be informed of the study aim and design and signed informed consent. Each patient was then studied before chemotherapy, after the first chemotherapy, and completion of anthracyclines therapy. The ATN dose, heart rate, height and weight of the patients were recorded at the same time of each study.