Immuno-friendly use of BCG-cell wall skeleton remarkably improves the survival rate of various cancer patients

Abstract

About 25 years ago, the study of cancer immunotherapy (IT) was done without paying due attention to patients' own immunogenicity, resulting in the failure in its clinical trials. This fact suggested that IT should be performed independently of other conventional chemo- and/or radiation therapies after removing as many tumor cells as possible. Between 1975 and 1997, total 235 cancer patients have been treated by IT with BCG-cell wall skeleton (CWS) alone, most just after surgical operations, and some after chemo- and/or radiation therapies. Appropriate dose (10 to 200 μg) of BCG-CWS depending on the patients' biological responses, inoculated intracutaneously every 4 weeks, monitoring their immunogenicity with IFN-γ induction test. In this pilot study, clinical effect of the immuno-friendly use of BCG-CWS was shown most clearly in the effect of IFN-γ induction and cancer stages on the survival rate. In fact this therapy was really effective for various kinds of cancers and for the patients in Stage I-III, but not for those in Stage IV or in immunologically impaired state. Further in 84 postoperative primary lung cancer patients, especially in the group of 46 Stage III patients, the effect was statistically significant (χ2=8.546, p=0.0035). These clinical and statistical analyses suggest that the IT with BCG-CWS alone displays its effect on cancers attacking their lymphnode metastasis.