Working With the National Cancer Institute

Abstract

To determine the efficacy of adjuvant chemotherapy in patients with advanced head and neck squamous carcinoma, the National Cancer Insitute initiated a multi-institutional, prospective randomized trial termed the Head and Neck Contracts Program. Between 1978 and 1982,462 patients with resectable Stage I11 or IV cancers of the oral cavity, larynx, or hypopharynx were randomly assigned to receive one of three treatment options: (1) induction chemotherapy consisting of a single course of cisplatin and bleomycin followed by standard therapy (surgery and postoperative radiotherapy); (2) induction chemo-therapy and standard therapy followed by maintenance chemotherapy which consisted of six cycles of monthly cisplatin; or (3) 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. Cancer 60:301-311, 1987. QUAMOUS CELL CARCINOMAS of the head and neck S region are among the most morbid of cancers. Treatment with surgery or radiation for small, locally confined tumors has resulted in 5-year survival rates of 70% to 90%. For patients with advanced, resectable cancers, 5-year survival rates range from 10% to 60%.5-8 Despite optimal local treatment with surgery and radiation therapy, local tumor control remains a significant problem, with local or regional recurrence in up to 50% of the cases. Only a small percentage can be salvaged with further surgery or radiation. Distant metastases occur in 10% to 30% of patients, and second primaries and other medical problems account for the remainder of death~.~,'-~ The unfavorable results, combined with the functional and cosmetic disabilities associated with treatment and/or local tumor recurrence, have led to the