The present study was designed to investigate the relationship between
the efficacy of the BCG instillation therapy, cytokine production of
peripheral blood mononuclear cells (PBMC) activated by BCG in vitro, a
nd the concentration of cytokines in serum and urine following BCC ins
tillation. We studied 7 patients who had carcinoma in situ of the urin
ary bladder. Tokyo strain 172 BCG was administered weekly for 8 weeks
as 80 mg of BCG in 40 ml of saline, instilled into the bladder and ret
ained for Z hours. Out of the 7 patients, 6 achieved complete remissio
n after 8 sessions of instillation. In 5 of the 7 patients, cytokine p
roduction by PBMC after incubation with BCG in vitro was studied. Afte
r co-culture of BCG and PBMC for 24 hours, concentrations of TNF alpha
and IFN gamma in the supernatant ranged from 216 to 3563 pg/ml (mean;
1146 +/- 1384), from 992 to 2030 pg/ml (mean; 1398 +/- 487), respecti
vely. Although concentrations of TNF alpha in serum were slightly elev
ated in 3 of 7 and IFN gamma in 1 of 7 patients at 6 hours following t
he first session of BCG instillation, concentrations of these cytokine
s in the urine were not elevated. There was no relationship between th
e tumor response to BCG therapy, concentrations of TNF alpha or IFN ga
mma in serum and urine, and the concentration of cytotoxic cytokines m
ediated by BCG in vitro.