Efficacy of Concurrent Chemoradiotherapy with Capecitabine and Cisplatin in the Management of Locally Advanced Squamous Cell Carcinoma of Oral Cavity

Aim: The benefit of chemotherapy as neoadjuvant or concurrent with radiotherapy in terms of overall survival has been demonstrated in locally advanced head and neck squamous cell cancer. We aimed to assess the efficacy and safety of concurrent capecitabine and cisplatin over concurrent cisplatin and 5-FU in locally advanced squamous cell oral cancer.

Material and Method: We randomly assigned 152 patients (all of whom had stage III or IV unresectable disease with no distant metastases and had received two cycles of taxol and cisplatin chemotherapy) to receive either (1) concurrent cisplatin (75 mg/m² on days 1 and 2) and 5-FU (750 mg/m² on days 1, 2, and 3) from the first day of radiotherapy at 3-week intervals, or (2) cisplatin (75 mg/m² on days 1 and 2) and capecitabine (750 mg/m² in two divided doses from days 1-14, with pyridoxine 200 mg in two divided doses) from the first day of radiotherapy at 3-week intervals.

The primary endpoint was to observe the benefits of concurrent capecitabine and cisplatin along with radiation over concurrent cisplatin and 5-FU along with radiation in response rate by comparing 3-year overall survival, progression-free survival, and disease-free survival in locally advanced squamous cell oral cancer. Major secondary endpoints observed included energy level, activity level, overall quality of life, and treatment-related acute and late toxicities in both the arms.

Results: The study showed that the complete response (CR) of tumor, node, and overall of ARM II was significantly higher (P < 0.05 or P < 0.01) compared with ARM I. Further, the dose reduction and treatment delay also lowered significantly (P < 0.05 or P < 0.01) in ARM II compared with ARM I.

The 3-year disease-free survival (χ2 = 0.89, P = 0.346), progression-free survival (χ2 = 2.59, P = 0.107), and overall survival (χ2 = 1.45, P = 0.229) of the two groups were found to be similar; i.e., they did not differ significantly (P > 0.05), although it was 3.00-(HR = 3.00, 95% CI = 0.30-30.58), 2.34- (HR = 2.34, 95% CI = 0.83-6.41), and 1.67-fold (HR = 1.67, 95% CI = 0.72-3.89) higher in ARM II compared with ARM I.

The changes in Hb, weight, energy level (EL), activity level (AL), and especially quality of life (QOL) of the two groups during the treatments and at the end of the study were compared. The levels of all variables were significantly different and higher in ARM II compared with ARM I, except weight. A significant difference was evident just after 1 month of treatment and became more prominent at the end of treatment.

Treatment-related acute and late toxicities were similar between the two groups; i.e., they did not differ significantly (P > 0.05).

Conclusion: Concurrent chemoradiotherapy with capecitabine and cisplatin was found to be well tolerated and effective in patients with locally advanced head and neck cancer. Accordingly, this regimen can be regarded as an important chemoradiotherapy option for advanced head and neck cancer.