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Cancer Research and Treatment > Accepted Articles
doi: https://doi.org/10.4143/crt.2020.1024    [Accepted]
Combination of Simvastatin and FAC Improves Response to Neoadjuvant Chemotherapy in Advanced Local Breast Cancer
Erwin Danil Yulian1, Nurjati Chairani Siregar2, Bajuadji 3
1Division of Surgical Oncology, Department of Surgery, Dr. Cipto Mangunkusumo General Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
2Department of Pathology, Dr. Cipto Mangunkusumo General Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
3Department of Surgical Oncology, Koja General Hospital, Jakarta, Indonesia
Correspondence  Erwin Danil Yulian ,Tel: 62-81315249627, Email: erwin.yulian@ui.ac.id
Received: October 10, 2020;  Accepted: March 7, 2021.  Published online: March 9, 2021.
The efficacy of neoadjuvant chemotherapy (NAC) for Locally Advanced Breast Cancer (LABC) is limited due to drug resistance and cardiotoxic effects. Pre-clinical studies have shown that statin induces apoptosis and decreases breast cancer cell growth. This study aims to evaluate the role of statin in combination with Fluorouracil, Adriamycin, and Cyclophosphamide (FAC) therapy in LABC patients.
Materials and Methods
We undertook a randomized, double-blinded, placebo-controlled trial in two centers of Indonesia. Patients were randomly assigned to FAC plus simvastatin (40 mg/d orally) or FAC plus placebo (40 mg/d) for 21 days. The FAC regimen was repeated every 3 weeks. We evaluated the clinical response, pathological response, and toxicities.
The ORR for FAC plus Simvastatin was 90% (95% CI 0.99-1.67) by per-protocol analysis. No complete responses (CR) were recorded, but there were 48 partial responses (PRs). No significant difference was observed between the two groups with the ORR (p=0.103). The pathological complete response rate was 6.25% (2 in Simvastatin group and 1 in placebo group). Adverse events in both arms were generally mild, mainly consisted of myotoxicity. HER-2 expression was a factor related to the success of therapeutic response (OR: 4.2, 95% CI: 1.121-15.731, p=0.033).
This study suggests that simvastatin combined with FAC shows improvements in ORR and pathological response in patients with LABC. Although no statistically significant difference was documented, there was a trend for better activity and tolerability. The addition of 40 mg simvastatin may improve the efficacy of FAC in LABC patients with HER-2 overexpression.
Key words: Neoadjuvant therapy, Breast neoplasms, FAC, Simvastatin
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