the role of lovastatin in curative chemoradiotherapy for patients with head and neck cancer: a randomized trial

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.