STOP-CA
Trial question
What is the role of atorvastatin in patients with lymphoma treated with anthracycline-based chemotherapy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 300
300 patients (142 female, 158 male).
Inclusion criteria: patients with lymphoma scheduled to receive anthracycline-based chemotherapy.
Key exclusion criteria: persistent and unexplained pretreatment elevation of serum ALT and AST > 3 times the ULN; standard contraindication to cardiac MRI; treatment with a statin or clinical indication for a statin.
Interventions
N=150 atorvastatin (at an oral dose of 40 mg/day for 12 months starting before first scheduled anthracycline infusion).
N=150 placebo (oral placebo for 12 months starting before first scheduled anthracycline infusion).
Primary outcome
Proportion of patients with an absolute decline in left ventricular ejection fraction ≥ 10% from prior to chemotherapy to a final value of < 55% over 12 months
9%
22%
22.0 %
16.5 %
11.0 %
5.5 %
0.0 %
Atorvastatin
Placebo
Significant
decrease ▼
NNT = 7
Significant decrease in the proportion of patients with an absolute decline in LVEF ≥ 10% from prior to chemotherapy to a final value of < 55% over 12 months (9% vs. 22%; OR 0.34, 95% CI 0.15 to 0.71).
Secondary outcomes
Significant decrease in the proportion of patients with an absolute decline in LVEF ≥ 5% from before chemotherapy to a final value of < 55% over 12 months (13% vs. 29%; RR 0.45, 95% CI 0.18 to 0.72).
No significant difference in incident HF (3% vs. 6%; RR 0.5, 95% CI -0.36 to 1.36).
No significant difference in overall survival (39.8 months vs. 35.1 months; AD 4.7 months, 95% CI -16.05 to 25.45).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with lymphoma scheduled to receive anthracycline-based chemotherapy, atorvastatin was superior to placebo with respect to proportion of patients with an absolute decline in LVEF ≥ 10% from prior to chemotherapy to a final value of < 55% over 12 months.
Reference
Tomas G Neilan, Thiago Quinaglia, Takeshi Onoue et al. Atorvastatin for Anthracycline-Associated Cardiac Dysfunction: The STOP-CA Randomized Clinical Trial. JAMA. 2023 Aug 8;330(6):528-536.
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