High-dose inhibition and low-dose enhancement of murine sarcoma growth exhibited by BCG vaccine.

An in vivo assay for BCG anti-cancer efficacy was developed, utilizing subcutaneous injection into CFW Swiss-Webster mice of cultured S180 sarcoma cells and mixed with freeze-dried TiceTM BCG vaccine. A BCG dose of 0.156-1.56 mg dry weight significantly inhibited tumor formation, but a BCG dose of 0.156-1.56 micrograms significantly enhanced tumor growth, evidenced by increased tumor incidence, volume and initial growth rate. These antagonistic activities may contribute to the high variability of BCG anti-cancer efficacy seen in animals and humans and indicate the need to exercise caution when employing even low doses of BCG for cancer immunotherapy.