Document Type : Original Article(s)


1 Radiation Oncology Research Center (RORC), Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran

2 Department of Radiation Oncology, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran



Background: Evidence suggests that statins can improve survival outcomes and ameliorate treatment-related side-effects in certain malignancies. Statins exhibit various mechanisms of action, including apoptosis induction, proliferation inhibition, tumor radiosensitization, lipid production suppression, and anti-inflammatory effects. This trial aimed to assess the impact of lovastatin on patients with locally advanced head and neck squamous cell carcinoma (HNSCC) undergoing definitive chemoradiation.
Method: In this double-blinded randomized phase 2 clinical trial, 35 patients were randomly allocated to receive either 80 mg of lovastatin daily in conjunction with chemoradiotherapy (case group, n=18) or a placebo (control group). Primary outcomes included the response rate (RR) after three months, the occurrence of acute/late side-effects, median progression-free survival (PFS), and overall survival (OS).
Results: The complete RR was slightly higher in the statin group (83.3% vs. 64.7%), although it did not reach statistical significance (P = 0.592). Acute adverse events did not significantly differ between the two groups. Grade 3 dermatitis occurred more frequently in the placebo group (35.3% vs. 11.1%), while grade 3 mucositis was more common in the statin group (38.9% vs. 11.8%). The median OS was 22 months (confidence interval (CI) 95% = 6.3-37.6) in the statin group and 17 months (CI 95% = 4.9-29.1) in the control group (P = 0.50). Median PFS was 20 months (CI 95% = 15.8-24.1) in the statin group and 15 months (CI 95% = 8.2-21.7) in the control group (P = 0.609).
Conclusion: Combining lovastatin with chemoradiation augments the therapeutic effect in HNSCC. Larger-scale studies incorporating advanced radiotherapy techniques and baseline lipid profile assessments are necessary to investigate statins' efficacy in HNSCC further.


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How to cite this article:

Sharifian A, Aghili M. The role of lovastatin in curative chemoradiotherapy for patients with head and neck cancer: a randomized trial. Middle East J Cancer. 2024;15(2):117-27. doi:10.30476/mejc.2023.97387.1911

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