FINAL RESULTS OF A RANDOMIZED TRIAL COMPARING CHEMOTHERAPY PLUS RADIOTHERAPY WITH CHEMOTHERAPY PLUS SURGERY PLUS RADIOTHERAPY IN LOCALLY ADVANCED RESECTABLE HYPOPHARYNGEAL CARCINOMAS

After neoadjuvant chemotherapy, a routine conservative approach follow ed by salvage surgery was evaluated in terms of local control and surv ival in cases of advanced potentially resectable hypopharyngeal carcin oma. Between 1985 and 1989, 92 patients with T3 or T4-N0,N3 operable s quamous cell hypopharyngeal carcinomas received three courses of neoad juvant chemotherapy every 2 weeks involving a combination of cisplatin , 100 mg/m(2), on day 1 and fluorouracil, 1 g/m(2), on days 2 to 5, fo llowed by total laryngopharyngectomy plus postoperative radiotherapy i n 47 patients (arm A) or radiotherapy alone in 45 patients (arm B). Ra ndomization was always performed prior to chemotherapy. The response r ates of turner and node to chemotherapy were, respectively, 67% in arm A versus 79% in arm B (P > 0.05) and 54% in arm A versus 73% in arm B (P > 0.05). Grade III or IV toxicity was similar, affecting 15% of pa tients and 7% of cycles in rum A versus 16% of patients and 6% of cycl es in arm B, After a mean follow-up of 92 months, survival was statist ically better (P = 0.04) in arm A (5-year overall survival, 37%; media n survival, 40 months) than in arm B (19% and 20 months) because of a better local control rate (63% versus 39%; P < 0.01). Better results w ere obtained for mutilant surgery in terms of local control and overal l survival, regardless of response to neoadjuvant chemotherapy.