CONCURRENT RADIOTHERAPY AND CONTINUOUS AMBULATORY INFUSION 5-FLUOROURACIL IN ADVANCED HEAD AND NECK-CANCER

Patients with locally advanced stage 3 or 4 recurrent squamous cell ca rcinoma of the head and neck received 5-fluorouracil (5-FU) 200 or 300 mg/m(2)/day by prolonged ambulatory infusion concomitantly with radio therapy (60-66 Gy) to the primary site and neck nodes in 30-33 fractio ns at five fractions per week, boosting to smaller volumes after 60 Gy . Of 39 patients, the complete response rate was 82% (95% CI: 67-93%). The estimated percentage without failure at 2 years was 59% (S.E. 8%) and at 4 years was 50% (S.E. 8%). Estimated head and neck cancer spec ific survival was 64% (S.E. 8%) at 2 years and 52% (S.E. 8%) at 4 year s. Acute toxicities included moist desquamation in 49% and dry desquam ation in 28%, confluent mucositis in 56% and patchy mucositis in 44%. Late effects, more than 6 months after completing treatment, assessed in 35 patients, included severe salivary dysfunction in 3 patients and moderate in 21, severe osteonecrosis in 4 patients and moderate toxic ity in subcutaneous tissues in 13, skin in 3 and mucosa in 2 patients. It is feasible to give continuous 5-FU concurrently with radiotherapy in locally advanced or recurrent head and neck cancer, albeit with in creased toxicity. The response rate and survival obtained in this tria l justify further investigation of the combined treatment in a randomi sed trial.