[Preliminary results of a prospective randomized study of primary chemotherapy in carcinoma of the oral cavity and pharynx].

Although induction chemotherapie given prior to local therapy produces encouraging initial response rates in head and neck cancer, randomized studies have failed to demonstrate an advantage in survival. All randomized studies have included only patients with far advanced stage III and IV disease. To us this is the main reason for the low rate of complete responses demonstrated (maximum, 18%). Frei et al. estimate that 40-50% complete responders are necessary before improved survival benefit will occur. To date, such complete response rates with induction chemotherapy are only attainable in resectable T2-T3, N0-N2 disease. Therefore, we started a prospective randomized trial that included only patients with earlier disease. Patients were randomized to receive either induction chemotherapy with 3 cycles of carboplatin/5-fluorouracil prior to surgery and radiotherapy (arm A, 49 patients) or standard treatment with surgery and radiotherapy (arm B, 48 patients). Patients were stratified by primary tumor site and neck disease. After a follow-up of 12-48 months, overall survival was 72% in arm A and 53% in arm B, but this difference was not significant. Considering only the results in patients with cancer of the oral cavity and tonsils, overall survival was 87% in arm A and 45% in arm B (p < 0.04). At present, the numbers of patients with cancers of the tongue base and hypopharynx are too small for a statistically significant statement. However, preliminary data indicate a better overall and disease-free survival without chemotherapy in these patients. Therefore, we now recommend induction chemotherapy in all patients with stage T2-T3 and N0-N2 carcinomas of the oral cavity and tonsils prior to surgery but not in patients with cancers of the hypopharynx and base of tongue.

RCT Entities:   Population Interventions Outcomes