Statins To Prevent The Cardiotoxicity From Anthracyclines: The STOP-CA Trial

Presented at the ACC.23 by: Prof. Marielle Scherrer-Crosbie, MD, PhD - Philadelphia, PA, USA

Introduction and methods

Background

Anthracyclines are used for the treatment of several cancers, including lymphoma. Use of anthracyclines is associated with cardiac injury and an increased risk of heart failure. Experimental data, retrospective studies and a small randomized trial have suggested that statins may have beneficial effect in reducing cardiac damage during treatment with anthracyclines. However, a recent randomized trial which largely focused on patients with breast cancer showed a neutral effect of atorvastatin on LVEF at 24 months compared to placebo.

Aim of the study

The STOP-CA trial aimed to investigate the effect of atorvastatin on the occurrence of cardiac

dysfunction in patients with lymphoma treated with anthracyclines.

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Methods

The STOP-CA trial was a double-blind, placebo-controlled, multicenter randomized trial, which was conducted at 9 sites in the US and Canada. The trial included adult patients with Hodgkin or non-Hodgkin lymphoma who were scheduled to receive chemotherapy with an anthracycline. Patients who already used statins or in whom statin use is indicated based on guidelines were excluded. A total of 300 patients were randomized (1:1) to receive either atorvastatin (40 mg/day) or placebo. Patients started therapy with atorvastatin or placebo prior to the first chemotherapy and continued for 1 year. LVEF was measured at baseline and at 1 year.

Outcomes

The primary endpoint was the proportion of patients who had a decline in LVEF of ≥10% to less than 55%. The secondary endpoint was the proportion of patients who had a decline in LVEF of ≥5% to less than 55%.

Main results

- The proportion of patients who had a decline in LVEF of ≥10% to less than 55% was 9% in the atorvastatin group and 22% in the placebo group (P=0.002). The odds of developing cardiac disfunction were almost 3 times higher in the placebo group compared to the atorvastatin group (OR 2.9, 95%CI 1.4-6.4).

- The incidence of the secondary endpoint was also significantly lower in the atorvastatin group compared to the placebo group (13% vs. 29%, P=0.001).

- Exploratory subgroup analyses showed that the benefit of statin therapy on change in LVEF from pretreatment to month 12 was more pronounced in female patients, patients aged >52 years, patients receiving anthracyclines ≥ 250 mg/m², and obese patients.

- There were no significant differences in incidences of muscle pain, elevated AST/ALT, myositis or renal failure between treatment groups.

Conclusion

The STOP-CA study showed that use of atorvastatin (40 mg/day) over 12 months was associated with lower rates of cardiac dysfunction in patients with lymphoma treated with anthracyclines.

-Our reporting is based on the information provided at the ACC.23/WCC-

Watch a video on the STOP-CA trial