Prospective observational study to assess the role of targeted agent Gefitinib as palliative treatment in residual, recurrent, and metastatic squamous cell carcinoma of head and neck.

Abstract

Background: Patients with advanced head and neck squamous cell carcinoma (HNSCC) remain at high risk of developing local recurrence and distant metastases. Some patients do respond well to treatment but still have residual disease or develop locoregional failure within 1-2 years. Treatment options are limited in such cases with dismal survival outcomes. This study was done to assess the role of Gefitinib in residual, recurrent, and metastasis HNSCC.

Ojbective: To assess the role of Gefitinib in residual, recurrent, and metastatic HNSCC in terms of overall response, progression-free survival, and toxicity profile of the drug in the palliative setting.

Material and methods: This was a prospective observational study with 42 patients of advanced HNSCC who had residual, recurrent, or metastatic disease after primary treatment with concurrent chemoradiotherapy. The patients were then treated with a standard dose of 250mg which was titrated as per the toxicity profile of the drug. The drug was continued till the progression of the disease or intolerable drug toxicity.

Results: All patients showed objective clinical and radiological response after the start of treatment as per RECIST 1.1 criteria. Three patients had disease progression within 4 months of start of treatment while 11 patients showed disease progression at 6 months of treatment and rest of the patient within 1 year of start of treatment. Median Progression free survival was found to be 6.1 months [95% Confidence interval 5.563 to 6.63]. Median overall survival (OS) time was 12 months [95% Confidence interval 11.84 to 12.16].

Conclusion: This study suggests the advantage of Gefitinib in patients having residual, recurrent or metastatic HNSCC in terms of clinical response, PFS and OS; similar to the Triple drug metronomic Chemotherapy regime. Though a head on comparison in a phase III trial is required for any conclusive evidence.