A Phase III Randomized Clinical Trial Study of Chemoradiation using Lovastatin/Cisplatin in Patients with Head and Neck Squamous Cell Carcinoma

Background: Target therapy of apoptosis signaling has been previously shown to have a therapeutic role in the treatment of head and neck squamous cell carcinoma (HNSCC). The present study aimed to investigate the safety and maximum dose of Lovastatin (80 mg/day) in additional standard therapy with cisplatin. Method: The current study is a phase III randomized clinical trial, conducted to determine the effect of Lovastatin on HNSCC. To eliminate the interference effect of previous treatments and surgeries, newly-diagnosed HNSCC patients were included. A total of 45 patients from May 2017 to February 2018 were enrolled. The intervention group received Lovastatin/cisplatin chemoradiotherapy and the control group received only cisplatin. All the subjects were evaluated on a weekly basis during the treatment and three and six weeks after that for related adverse events (AEs). The response rate to the treatment was assessed eight weeks following the treatment. Results: No significant differences were found between the two groups concerning the objective response (OR) rate (95.8% vs. 95.2%, P = 1, 95% confidence interval). In the intervention group, tumors were entirely removed in 70.8% of the subjects and partial response was seen in 25% of them. No patient was excluded due to the AEs. The gastrointestinal AE (31.1%) was the most frequent one. Conclusion: In the present study, comparing the intervention and control groups, no significant differences were observed concerning OR, but unlike previous investigations, the related cardiac AEs were not seen. This observation confirmed the hypothesis that there is a possible association of Lovastatin use with better o‎r compared with standard chemoradiation (cisplatin) in the initial point of the treatment. However, further research is needed to investigate different doses of Lovastatin with longer follow-ups and new diagnoses of HNSCC patients.