A NATURAL CYTOKINE MIXTURE IRX-2 AND INTERFERENCE WITH IMMUNE SUPPRESSION INDUCE IMMUNE MOBILIZATION AND REGRESSION OF HEAD AND NECK-CANCER

Prior studies indicate that combination immunotherapy of squamous cell cancer (SCC) of head and neck (H&N) with cytokines is feasible (Hadde n ei al., 1994). To induce immune regression of H&N SCC 20 stage II-IV patients received 3 weeks prior to surgery low dose cyclophosphamide (300 mg/M-2), then 10 daily perilymphatic injections of a natural cyto kine mixture (IRX-2) (150 units of IL-2 equivalence) and daily oral in domethacin and zinc. Tumor responses, T-lymphocyte and subset counts, and toxicity were monitored. Six patients had major clinical responses (both complete [CR] and partial [PR]) without major toxicity. Five of 20 patients were lymphocytopenic (1242+/-88 mm(3)) prior to treatment and the immunotherapy induced marked significant increases in total l ymphocyte counts, CD3+ T-cells, and both CD4+ and CD8+ T-cells as well as a population of CD3+, CD4-, and CD8- lymphocytes. The post treatme nt specimen of 18/20 patients showed histologically tumor fragmentatio n, overall reduction and diffuse infiltration with lymphocytes and pla sma cells. Histologic tumor reductions in these patients averaged 44% and the lymphoid infiltration increased 4.7 fold from 9-42%. The immun e infiltration of the tumor reflects varying degrees of both T- and B- cells and indicates immunization to the tumor. The immunization achiev ed may improve clinical control of H&N SCC by improving the possibilit y that surgical resection of advanced loco-regional disease will leave no viable tumor. (C) 1998 International Society for Immunopharmacolog y.