Re-evaluation of immunological parameters in immunotherapy for advanced carcinoma of the digestive tract.

Fifty-one patients with recurrent carcinoma of the digestive tract received immunotherapy consisting of the streptococcal preparation OK-432 in combination with FT207. In these patients, the following tests were carried out, peripheral blood leukocyte count, lymphocyte count and percent T-cell population of lymphocytes, delayed hypersensitivity skin tests with PPD, phytohemagglutinin and polysaccharide extracted from Su strain of Streptococcus pyogenes and serum titer of agglutinin to Strep. pyogenes. The results were statistically analyzed and correlated with the rate and duration of survival in order to re-evaluate the immunological parameters commonly used at present in anticancer immunotherapy. With respect to the peripheral blood leukocyte count, lymphocyte count, delayed hypersensitivity skin tests and serum titer of agglutinin to Strep. pyogenes assessed at 2 months of treatment, patients showing normal values or positive results had a significantly greater survival rate compared with those showing abnormal values or negative results. The peripheral blood lymphocyte count, delayed hypersensitivity skin tests and serum titer of agglutinin to Strep. pyogenes correlated significantly with survival. Particularly, the Su-PS skin test and serum titer of agglutinin to Strep. pyogenes showed remarkable correlation (P less than 0.01) with the survival rate and period.