Results from the STOP-CA trial suggest that statins may be cardioprotective in patients receiving chemotherapy with anthracyclines for lymphoma. Participants in this phase 2, multicenter, randomized trial were significantly less likely to experience heart dysfunction after taking atorvastatin for 1 year.
Each year, more than 1 million patients with cancer worldwide are treated with anthracyclines, such as doxorubicin, epirubicin, and idarubicin. Tomas Neilan, MD, noted at the 2023 American College of Cardiology annual meeting that these agents have been known for decades to be cardiotoxic.1 Patients treated with anthracyclines have a 10- to 15-fold increased risk for heart failure (HF). Dr. Neilan explained the choice to include patients with lymphoma in the STOP-CA (NCT02943590) by the high survival rate, which renders the impact of late toxicities of added importance.
The study enrolled 300 patients with lymphoma scheduled to receive treatment with an anthracycline at a median dose of 300 mg/m2. The median age was 52 and 47% were women. Participants were randomized to atorvastatin 40 mg daily or matching placebo, starting before their first dose of anthracyclines and continuing for 1 year. The study’s primary endpoint was the proportion of participants with a decline in left ventricular ejection fraction (LVEF) of at least 10% to a final value of less than 55% after 1 year.
The study was completed by 286 patients (95%). Adherence to atorvastatin was documented in more than 90%. At baseline, the LVEF was 63% across the cohort; after 1 year, it was 58%. The LVEF decreased by 4.1% in the atorvastatin group and by 5.4% in the placebo group. The primary endpoint occurred in 9% of the atorvastatin group and 22% in the placebo group (P=0.002). The odds of a 10% or greater decline in the LVEF to less than 55% after anthracyclines was almost three times higher in the placebo group: OR, 2.9 (95% CI, 1.4–6.4). A decline in LVEF of at least 5% to less than 55% was observed in 13% of the atorvastatin group and 29% of the placebo group (P=0.001).
Atorvastatin 40 mg was safe, with no effect on heart rate, blood pressure, blood parameters (other than lipids), and no serious study-related side effects. There were 11 cases of HF, with no difference between groups (P=0.77). Dr. Neilan noted that it is unclear if the 12-month beneficial effect of atorvastatin would have been noted had the LVEF been checked at a later timepoint.
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