Background: To determine the maximally tolerated dose (MTD) of capecitabine when given concomitantly with carboplatin and intensity-modulated radiation therapy (IMRT) for treatment of localized stage III/IV squamous cell carcinomas of the head and neck (HNSCC).
Patients and methods: After six weeks of induction chemotherapy with capecitabine and carboplatin, patients received a second course with concomitant IMRT. The MTD for capecitabine during chemoradiation was determined by a standard phase I trial design.
Results: Nine out of the eleven patients qualified for chemoradiation. With weekly carboplatin AUC=1.5 and IMRT, the MTD of capecitabine was 850 mg/m(2)/day when given in divided doses on days 1-14 and 22-35. The dose-limiting toxicity was myleosuppression and other adverse effects were modest. Eight patients experienced complete response after chemoradiation and seven remain relapse-free after 34 months.
Conclusion: Capecitabine, carboplatin, and IMRT given as described were well tolerated by HNSCC patients and in this pilot study produced a promising rate of disease control.