Intensive recombinant interleukin‐2 and alpha‐interferon therapy in patients with advanced head and neck squamous carcinoma

Background. Cellular immune deficiency is a consistent finding in patients with advanced head and neck cancer. Interleukin‐2 and alpha‐interferon are modulators of the immune system. Methods. Eleven patients with recurrent head and neck cancer were treated in a Phase II study of recombinant human interleukin‐2 (rIL‐2) and alpha‐2a‐interferon (Roferon‐A, Hoffmann‐La Roche, Inc., Nutley, NJ). Each course consisted of rIL‐2, 3 × 10⁶ U/m²/day, as a continuous intravenous infusion over 24 hours for 4 days, and recombinant alpha‐2a‐interferon, 5 × 10⁶ Um²/day intramuscularly or subcutaneously daily for 4 days. This treatment was repeated weekly for 4 weeks, and then a second cycle was given after a 2‐week break. Results. Two patients (18%) achieved a partial response. Toxic effects were substantial. Three of 11 patients experienced Grade 3 hypotension, 3 patients had Grade 3 oliguria, and Grade 3 fatigue was one of the most common reasons for withdrawal from the study. There were no deaths or need for intensive care monitoring. Conclusions. In view of the 18% response rate, additional investigation of biologic therapy in advanced head and neck cancer is warranted.