Method for predicting the response to treatment with bcg of superficial

Abstract

The invention relates to a method and kit for the prediction of the response of a patient suffering from superficial bladder carcinoma to treatment with bacillus Calmette-Guerin (BCG), by calculating the inducibility of the Interleukin-2 (IL-2) gene of the patient in a sample of peripheral blood mononuclear (PBM) cells from the patient receiving BCG. The method includes the steps of culturing at least two aliquots of PBM from the patient where the cells in a first aliquot are cultured in the presence of an inducing agent for inducing expression of the IL-2 gene and the cells in the second aliquot are cultured in the absence of the inducing agent. The extent of expression of the IL-2 gene is quantitatively determined for each aliquot. The ratio of the extent of the expression of the IL-2 gene in the first aliquot to the extent of the expression of the IL-2 gene in the second aliquot is calculated, the ratio providing a measure of the inducibility of the IL-2 gene. The inducibility is in a direct relationship with the probability of entering remission, relapse or persistence of bladder carcinoma in the patient. Patients with a ratio below about 1.5 can be treated either with a cytokine preparation, a second course of treatment with the BCG or a second course of treatment with the BCG in combination with a cytokine preparation to improve response.