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.