Simultaneous chemo-radiotherapy with 5-FU/folinic acid/cis-platinum and accelerated split-course radiation in...

In a clinical phase-II trial, 62 previously untreated patients suffering from unresectable stage III (4 patients) and IV (56 patients) squamous cell carcinoma of the head and neck were treated with a simultaneous chemoradiotherapy consisting of a 5-fluorouracil/folinic acid/cis-platinum combination and of an accelerated split-course radiotherapy. As results, 3 patients died from tumor arrosion bleeding during the treatment. The median follow-up time of the surviving patients is 27+ months (range 18-44 months). Forty-eight out of 62 patients (77%) achieved complete remission, and 11/62 patients (18%) partial remission. Presently, 32 patients (52%) are without evidence of disease. The actuarial 3-year overall survival rate (Kaplan-Meier method) out of 62 patients is 53%. The actuarial disease-free survival and local tumor control rates at 3 years are 58% and 72%. Toxicity on oral mucosa was severe but tolerable, bone marrow depression was marked but not life-threatening. In conclusion, this combined simultaneous modality approach is highly effective in locally advanced head and neck cancer. It appears to provide superior survival and local control rates as compared to conventional radiotherapy or sequential chemo-radiotherapy.