Assessment of the Therapeutic Effect of Atorvastatin in the Postmenopausal Metastatic Luminal Breast Cancer Women Receiving Aromatase Inhibitors

Background: Statins exhibit pleiotropic effects, including antioxidant, antiproliferative properties, which contribute to their therapeutic potential across multiple anti-inflammatories, and diseases. Owing to their antiproliferative activity, several in vitro and in vivo studies have explored the impact of statins on different cancer types—such as breast, prostate, colorectal, ovarian, and lung cancers—with diverse genetic and molecular profiles. Objective: This study aimed to evaluate treatment response to aromatase inhibitors (AI) after adding atorvastatin, and to assess its safety, tolerability, 2-year PFS, and 2-year OS. Material and methods: This randomized prospective phase III study included patients with metastatic luminal breast cancer (BC) receiving AI. Patients were allocated into two groups: Group I (control arm), treated with AI alone, and group II (experimental arm), treated with AI plus atorvastatin. Atorvastatin was administered at a dose of 20 mg once daily at bedtime alongside AI therapy. Results: The study included 97 patients (47 experimental, 50 control). No complete responses occurred, but partial response was significantly higher in the experimental arm (70% vs. 48%; P=0.027). Disease progression was lower with atorvastatin (17% vs. 42%; P=0.007). Atorvastatin showed good tolerability, with only 8.5% experiencing grade I–II toxicity. Two-year progression-free survival (PFS) significantly improved in the experimental arm (83% vs. 58%; P=0.006), while 2-year OS remained comparable (97.9% vs. 98%; P=0.95) Conclusion: The concurrent use of atorvastatin with aromatase inhibitors in metastatic luminal breast cancer enhanced the responsiveness to aromatase inhibitors, shown good medication compliance, had a minimal safety profile, and significantly increased PFS, without affecting two-year OS.