Evaluation of cardiotoxicity of anthracycline‐containing chemotherapy regimens in patients with bone and soft tissue sarcomas: A study of the FDA adverse event reporting system joint single‐center real‐world experience

Abstract

ObjectivesTo assess the occurrence of cardiotoxicity in patients with tumors receiving anthracycline‐based chemotherapy, especially for sarcomas.MethodsThis study summarized the types and frequency of adverse events (AEs) for three anthracyclines from the FDA adverse event reporting system (FAERS) database. FAERS data from January 2004 to June 2022 were collected and analyzed. Disproportionality analyses, logistic regression, and descriptive analysis were used to compare the differences in cardiac disorders. A retrospective cohort study was conducted in a single center between December 2008 and May 2022. Our hospital‐treated patients with bone and soft tissue sarcomas (BSTSs) with anthracycline‐containing chemotherapy were analyzed. Serum markers, echocardiography, and electrocardiography have been used to evaluate cardiotoxic events.ResultsOne hundred thousand and seventy‐five AE reports were obtained for doxorubicin (ADM), epirubicin (EPI), and liposome doxorubicin (L‐ADM) from the FAERS database. ADM (OR = 3.1, p < 0.001), EPI (OR = 1.5, p < 0.001), and sarcomas (OR = 1.8, p < 0.001) may increase the probability of cardiac disorders. Cardiac failure, cardiotoxicity, and cardiomyopathy were anthracyclines' top 3 frequent AEs. Among patients receiving ADM‐containing therapy, those with ADM applied at doses ≥75 mg/m2/cycle were more likely to develop cardiac disorders than the other subgroups (OR = 3.5, p < 0.001). Patients younger than 18 are more likely to benefit from dexrazoxane prevention of cardiac failure. Six hundred and eighty‐three patients with BSTSs receiving anthracycline‐based chemotherapy were analyzed in our center. Patients receiving ADM‐containing chemotherapy were likelier to experience abnormalities in serum troponin‐T and left ventricular ejection fraction (p < 0.05). 2.0% (6/300) of patients receiving ADM‐containing chemotherapy required adjustment of the chemotherapy regimen because of cardiotoxicity, whereas none were in the EPI or L‐ADM groups.Conclusions and RelevanceAmong patients receiving anthracycline‐containing therapy, patients with BSTSs were more likely to develop cardiac disorders than other tumors. In addition, patients with BSTSs receiving ADM chemotherapy had a higher likelihood of cardiotoxic events than those receiving EPI or L‐ADM.

Successful treatment of enormous locally advanced breast cancer through neoadjuvant chemotherapy and surgical intervention: a case report

“…Nevertheless, the TCbHP regimen demonstrated a shorter duration of cardiotoxicity compared to the AC-THP regimen, which may be attributed to the adverse effects of anthracycline-induced damage on cardiomyocytes, leading to diastolic and systolic dysfunction of the heart. This eventually results in a decrease in left ventricular ejection fraction and potential complications like cardiac failure and cardiomyopathy ( 15 ). Therefore, in this case, the selection of a TCbHP regimen was based not only on its mild cardiac-related adverse effects but also on our belief that early double-targeted therapy should be administered promptly to this patient with a high histological grade, large tumor size, high Ki-67 index, low estrogen receptor (ER) expression, and negative progesterone receptor (PR) expression in the initial stage of treatment.…”

Comparing the difference of adverse events with HER2 inhibitors: a study of the FDA adverse event reporting system (FAERS)

“…Meanwhile, because the permeability of the blood-brain barrier between small-molecule drugs and ADCs is significantly different, the differences in these drug-induced nervous system disorders remain unknown ( Stemmler et al, 2007 ; Guntner et al, 2020 ). FAERS database can provide a full range of reported events related to AEs of different drugs in real-world evidence from worldwide ( Mo et al, 2023 ). Therefore, this study is based on the FAERS database to assess the differences in multiple SOC-related AEs suspected to be associated with one HER2 inhibitor or multiple HER2 inhibitors, especially those related to hemorrhagic events and nervous system disorders.…”