Key result
Cardiovascular risk management before fluoropyrimidine treatment shows no significant MACE benefit over standard care.
Why the study?
Fluoropyrimidines have cardiotoxic side effects, but whether pre-chemotherapeutic cardiological assessment and cardiovascular risk factor management can prevent toxicity, and whether coronary artery calcium scoring predicts chest pain, remains unknown.
Does pre-chemotherapeutic cardiological management of cardiovascular risk factors reduce major adverse cardiovascular events in cancer patients treated with fluoropyrimidines?
RCT (n=192)
Open-label
1:1
No
Does pre-chemotherapeutic cardiological management of cardiovascular risk factors reduce major adverse cardiovascular events in cancer patients treated with fluoropyrimidines?
Effect estimate: IRR 0.57 (95% CI 0.22-1.39)
Absolute Event Rate: 9.5% vs 15.5%
p-value: p=0.19
Pre-chemotherapeutic cardiological management of cardiovascular risk factors in cancer patients receiving fluoropyrimidines resulted in a non-significant halving of cardiotoxic events, highlighting the need for adequately powered trials.
BACKGROUND: Fluoropyrimidines (FP) are the third most used chemotherapeutic drugs administered in solid tumors but have cardiotoxic side effects. We aimed to determine whether pre-chemotherapeutic cardiological assessment and management of cardiovascular risk factors could prevent FP-induced cardiotoxicity and if the coronary artery calcium (CAC) score was predictive of chest pain. METHODS: This was a randomized, controlled, single center trial of patients with various cancer types who were treated with FP and had no known ischemic heart disease. All patients had CAC score obtained by cardiac CT scan. Patients were randomized to pre-chemotherapeutic cardiological management or standard care. Cardiological management included risk reduction based on electro- and echocardiographic evaluation and blood samples. Primary composite endpoint included hospital admission for chest pain, acute coronary syndrome, coronary angiography intervention, or all-cause mortality. Secondary outcome was chest pain. Follow-up was 6 months. Data were analyzed using Kaplan-Meier survival function with log-rank test and ROC-analyses. RESULTS: Of the 192 patients included, the primary endpoint occurred in 9/95 (9.5%) patients in the intervention group and 15/97 (15.5%) patients in the control group (log-rank p = 0.19) with an incidence rate ratio (IRR) of 0.57 (95% CI [0.22 - 1.39]). Chest pain occurred in 6/95 (6.3%) patients in the intervention group and 13/97 (13.4%) in the control group, yielding an IRR of 0.44 (95% CI [0.14 - 1.23]). CAC score did not predict chest pain occurrence. CONCLUSIONS: Cardiological management of cardiovascular risk factors prior to treatment with fluoropyrimidines resulted in half as many cardiotoxic events but the study did not reach statistical significance. Further studies are needed to investigate the optimal strategies to prevent fluoropyrimidine-induced cardiotoxicity in cancer patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifyer NCT03486340.
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Lyhne et al. (2025) conducted an RCT in Cancer patients treated with fluoropyrimidines without known ischemic heart disease (n=192). Pre-chemotherapeutic cardiological assessment and management of cardiovascular risk factors vs. Standard oncological assessment (standard care) was evaluated on Major Adverse Cardiovascular Events (MACE) including hospital admission for chest pain, ACS, coronary angiography intervention, or all-cause mortality (IRR 0.57, 95% CI 0.22-1.39, p=0.19). Cardiological management of cardiovascular risk factors prior to fluoropyrimidine treatment reduced MACE by 43% (IRR 0.57) compared to standard care, though not statistically significant (p=0.19).
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