Adjuvant chemotherapy for advanced head and neck squamous carcinoma. Final report of the Head and Neck Contracts Program.

To determine the efficacy of adjuvant chemotherapy in patients with advanced head and neck squamous carcinoma, the National Cancer Institute initiated a multi-institutional, prospective randomized trial termed the Head and Neck Contracts Program. Between 1978 and 1982, 462 patients with resectable Stage III or IV cancers of the oral cavity, larynx, or hypopharynx were randomly assigned to receive one of three treatment options: induction chemotherapy consisting of a single course of cisplatin and bleomycin followed by standard therapy (surgery and postoperative radiotherapy); induction chemotherapy and standard therapy followed by maintenance chemotherapy which consisted of six cycles of monthly cisplatin; or standard therapy alone. Toxicity from the chemotherapy regimens was minimal. Induction therapy resulted in an overall complete response of 3% and a partial response in 34% of patients. With a median follow-up of 61 months, overall survival and disease-free survival were not markedly different among the three groups (P = 0.86 and P = 0.16, respectively). The incidence of distant relapse was reduced in the maintenance group compared to standard or induction groups (P = 0.025 and P = 0.021, respectively) and time to first distant relapse was prolonged (P = 0.032 and P = 0.022, respectively). The results confirm the feasibility of administering chemotherapy prior to surgery or radiation in patients with head and neck cancer but fail to demonstrate a significant impact of one cycle of induction chemotherapy on clinical outcome. The suggestion that distant relapse rates may be reduced with the addition of maintenance chemotherapy supports the need to test traditional adjuvant approaches in patients with advanced head and neck cancer.

RCT Entities:   Population Interventions Outcomes