Radiochemotherapy with cisplatin and oral tegafur in advanced head and neck cancer: long-term results of a phase II study

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Aims and background.

To evaluate the tolerance and efficacy of an original concurrent radiochemotherapy regimen in locally advanced head and neck cancer.


Sixty-four patients with stage III or IV squamous cell carcinoma arising from a head and neck mucosal site were eligible. Simultaneous radiochemotherapy consisted of two courses of continuous infusional cisplatin (20 mg/m2/d, days 1–4 and 29–32) and oral tegafur (1200 mg/d, days 1–14 and 29–43), together with conventional radiation therapy up to a total dose of 70–75 Gy over nine weeks.


All the patients were evaluated for toxicity and response. Acute mucositis was the most prevalent complication. Grade 3 toxicities were mucositis (44%), skin toxicity (10%), leukopenia (8%), and thrombocytopenia (1%). No toxic death was observed. Complete response to treatment was observed in 72% of patients. With a median follow-up of 48.5 months (range, 27–84), 5-year actuarial rate of local-regional control, disease-free survival, overall survival and disease-specific survival were 60% (95% confidence interval [CI], 40–70%), 55% (95% CI, 45–65%), 51% (95% CI, 43–59%) and 61% (95% CI, 53–69%), respectively.


Response, local-regional control and survival rates are equivalent to those reported from other concomitant radiochemotherapy combinations. However, the regimen offers the advantage of its tolerance and toxicity profile.

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