Abstract

The tube LAI assay measures accurately antitumor immunity in patients with early cancer but fails to detect up to 75% of patients with advanced cancer due to excess circulating organ-specific neoantigen (OSN). Substances such as prostaglandin E2 (PGE2) or aminophylline, which increase intracellular nucleotides in leukocytes of patients with advanced cancer reversed this nonreactivity and greatly increased the sensitivity of the assay without any loss of specificity. Antitumor immunity can now be detected in advanced cancer, and a combination of the two assays gives prognostic potential to the assay: a positive test with PGE2 and negative test without indicates the patient has a large tumor burden. The specificity of the assay for each cancer was high and in most instances was greater than or equal to 95%. The PGE2 stimulated assay retained the high specificity. The sensitivity of the regular tube assay was often low, 33-56% because of the many advanced cancer patients tested, whereas the PGE2 stimulated assay showed almost a two-fold increase in sensitivity, 67-93%. The diagnostic value of the assay was estimated by calculating the predictive value for different prevalences of cancer. It was found that at low prevalences of cancer as found in the general population, the assay had a low diagnostic value since few patients with a positive test would have the cancer tested for. With prevalences of cancer of 5% or greater as might be found in a tertiary care clinical setting, the assay would seem to have diagnostic value since one half or more patients with a positive test would have the cancer tested for. Most false positives, but not all, are found in patients who have lesions that are often considered to increase their risk for cancer: severe dysplasia of the breast, colon adenomas, chronic atrophic gastritis and chronic pancreatitis, suggesting that the assay predicts oncogenesis.

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