1. The Role of Lovastatin in Curative Chemoradiotherapy for Patients with Head and Neck Cancer: A Randomized Trial.
- Author
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Sharifian, Azadeh, Karbasi, Ehsan, Kazemian, Ali, Nourbakhsh, Forouzan, Nazari, Reza, and Aghili, Mahdi
- Subjects
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SQUAMOUS cell carcinoma , *COMBINATION drug therapy , *CANCER relapse , *SKIN inflammation , *HEAD & neck cancer , *STATISTICAL sampling , *BLIND experiment , *LIPIDS , *CHEMORADIOTHERAPY , *RANDOMIZED controlled trials , *CONTROL groups , *PRE-tests & post-tests , *DRUG efficacy , *STATINS (Cardiovascular agents) , *PROGRESSION-free survival , *CONFIDENCE intervals , *LOVASTATIN , *OVERALL survival - 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, n=17). Primary outcomes included the response rate (RR) after three months, the occurrence of acute and 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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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