Clinical benefits of concurrent capecitabine and cisplatin versus concurrent cisplatin and 5-flurouracil in locally advanced squamous cell head and neck cancer.

We aimed to assess the efficacy and safety of concurrent capecitabine and cisplatin over concurrent cisplatin and 5-flurouracil (5-FU) in locally advanced squamous cell carcinoma of the head and neck. One hundred and fifty-three patients (all of whom had stage III or IV unresectable disease with no distant metastases and who had received two cycles of taxol and cisplatin chemotherapy) were randomly assigned to receive either concurrent cisplatin (75 mg/m(2) in day 1 and 2) and 5-FU (750 mg/m(2) in day 1, 2, and 3) from the first day of radiotherapy at an interval of 3 weeks (Arm I) or cisplatin (75 mg/m(2) in day 1 and 2) and capecitabine (750 mg/m(2) in two divided doses from day 1-14) from the first day of radiotherapy at a 3-week interval (Arm II). Results showed that patients in Arm II had a significantly better rate of complete response, fewer nodes, and better overall response compared to those in Arm I. The two groups had a similar 3-year disease-free survival, progression free survival, and overall survival, i.e. they did not differ significantly. Variables indicating the quality of life of the two groups were compared. Patients in Arm II had a significantly higher quality of life compared to those in Arm I. The two groups had similar treatment-related acute and late toxicity, i.e. they did not differ significantly. These results have thoroughly substantiated the contention that concurrent chemoradiation with capecitabine and cisplatin may be regarded as an effective and well-tolerated regimen in the treatment of the patients with locally advanced head and neck cancer.