Results of a prospective randomized trial with induction chemotherapy for cancer of the oral cavity and tonsils

Although induction chemotherapy administered prior to local therapy produce s encouraging initial response rates in head and neck cancer, randomized st udies have failed to demonstrate an improvement in survival rates. All rand omized studies included only patients with advanced stage III and IV diseas e. In our opinion, this is the main reason for the low rate of complete res ponses demonstrated in the randomized trials (maximum 18%). Frei et al. est imate that a 40%-50% complete response rate is necessary before improved su rvival rates are seen. To date, such complete response rates with induction chemotherapy have only been attainable in resectable T2-T3, N0-N2 disease. Therefore, we initiated a prospective randomized trial including only pati ents with the mentioned disease stages. Patients (pts) were randomized to r eceive either induction chemotherapy with three cycles of carboplatin/5-FU prior to surgery and radiotherapy (arm A, 70 pts) or standard treatment wit h surgery and radiotherapy (arm B, 74 pts). Patients were classified accord ing to primary tumour site and neck disease. The observed remission rate af ter chemotherapy confirmed the primary estimated rate for this subgroup of patients with head and neck cancer (CR:43%, PR:37%, NR:15%, PD:5%). After a follow-up of 12-96 months overall survival was 58% in arm A and 45% in arm B (n.s.). Disease-free survival in arm A (61%) is statistically significan tly better than in arm B (43%, P=0.03). Therefore, we recommend further con trolled trials to investigate the role of induction chemotherapy in patient s with primary resectable carcinomas of the oral cavity and tonsils and sta ge T2-T3 and N0-N2 disease prior to surgery.