Phase II study of synchronous chemoradiotherapy with capecitabine in patients with locally advanced squamous cell carcinoma of the head and neck.

Abstract

5570 Background: Cisplatin may be relatively non-discriminating in its radiosensitising action. We evaluated the efficacy of concurrent oral capecitabine with accelerated hypofractionated radical radiotherapy in locally advanced squamous cell carcinoma of head and neck (SCCHN). Methods: 50 patients with stage III/IV SCCHN were enrolled. Nineteen patients received 450-550 mg/m2capecitabine twice daily, for 28days as a part of phase I study and 31 received 500 mg/m2BD. Radiotherapy prescribed dose was 5,500cGy in 20 fractions over 4 weeks. Results: Median age was 55 (range 38-76) years, 72% had stage IV disease. Median duration of follow-up was 6 years. Forty one out of 50 (82%) patients completed the full course of capecitabine and 47/50 (94%) completed the initially prescribed radiotherapy. There were no treatment related deaths. There was no grade 3/4 haematological or renal toxicity. Five patients developed drug related grade 3 or 4 acute toxicity (cardiac, skin, bowel), 47 developed grade 3 (44) or 4 (3) mucositis from chemoradiotherapy. Twenty-two (44%) patients required tube feeding for acute mucositis with one (2%) being tube dependent at 1 year. Complete response rate at 3 months was achieved in 47/50 (94%) of patients. Relapse occurred in 14/50 (28%) patients at 5 years. The loco-regional control, overall survival and cancer specific survival at 3 and 5 years were 78% and 72%, 72% and 64% and 82% and 75% respectively. Conclusions: This schedule of capecitabine for locally advanced SCCHN is well tolerated. The local control in this series compares favourably with other synchronous chemoradiotherapy reports. Chronic dysphagia and tube dependence is uncommon with this approach. Capecitabine as targeted therapy given with each fraction of radiotherapy and administered orally may have significant advantages over intravenous, 3 weekly cisplatin. No significant financial relationships to disclose.