Middle East Journal of Cancer

The Role of Lovastatin in Curative Chemoradiotherapy for Patients with Head and Neck Cancer: A Randomized Trial

Document Type : Original Article(s)

Authors

Azadeh Sharifian 1
Mahdi Aghili 2

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

https://doi.org/10.30476/mejc.2023.97387.1911
Abstract
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.

Keywords

Head and neck neoplasms
Squamous cell carcinoma
Statin
Chemoradiotherapy
Subjects

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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