Role of low dose capecitabine and erlotinib in treatment of recurrent or metastatic head and neck cancer.

Abstract

e18003 Background: Head and neck squamous cell carcinoma (HNSCC) is one of the most common cancers in Pakistan. Its incidence is rising continuously due to excessive and habitual use of tobacco related products. Most of the patients present in advanced stage of the disease that is incurable with most of the modalities available for treating these patients. Many of the treated patients have residual or recurrent disease in their early follow up. There is no current standard treatment for these patients and there is a need for offering a treatment that is effective, tolerable and relative cost-effective. The aim of this study is to assess the efficacy of low dose capecitabine and erlotinib in patients with recurrent or metastatic HNSCC. Methods: A total of 86 patients were enrolled for this study. All patients had received chemoradiotherapy (in combination or alone) for HNSCC at least three months before enrollment. After basic evaluation for normal blood counts, renal function and liver function. Patients were prescribed oral capecitabine 500mg twice a day and oral erlotinib 150 mg daily for a total period of six months. Patients were evaluated clinically monthly for response to treatment and any toxicity. The treatment was continued in the responders (patients showing response without any progressive disease). Radiological response to treatment was assessed through examination and imaging (CT/MRI which ever used at baseline) after six months of start of treatment. The primary end point of the study was to assess progression free survival (PFS). Overall survival (OS) was also assessed as a secondary end point. Results: A total of 72/86 (84%) patients completed at least six-month of treatment and were available for assessment of response and study endpoints of PFS and OS. 11 (15%) of patients progressed during the treatment and were shifted to other modes of therapy. No patient showed complete response. Partial response was seen in 32 (44%) patients while 29 (40%) of patients showed stable disease. Two-year PFS and OS were 18% and 40% respectively. Mean and median PFS (year) were 1.56 ±0.17 (95% confidence interval 1.22 to 1.90) and 0.93±0.13 (95% confidence interval 0.67 to 1.19) respectively. Mean and median OS (year) were 2.14 ±0.21 (95% confidence interval 1.72 to 2.56) and 1.61±0.11 (confidence interval 1.39 to 1.83) respectively. Conclusions: Metronomic chemotherapy with low dose capecitabine in combination with erlotinib is a valid option in recurrent or metastatic HNSCC.