[Intratumor immunotherapy with BCG cell wall preparations: development of a new therapy approach for head-neck tumors].

The present study deals with the influence of intratumoral injections of BCG cell-wall preparations (CWP) on the development of malignant tumors in the head-neck region. Line 10 tumor cells in strain 2 guinea pigs were used in a first assay. It became evident that intratumoral BCG-CWP injection leads to total tumor regression, a situation which can also be achieved by radical surgery. In contrast to the radically operated animals, those injected intratumorally with BCG-CWP develop a tumor-specific immunity. A second animal system was used to examine the effect of intratumoral BCG-CWP treatment on the development of autochthonous squamous cell carcinomas in cows. In this model, radical surgery leads to a clinical cure in all cases, while intratumoral BCG-CWP therapy leads to a complete clinical cure in 50% of the animals (observation period: 1 year). On the basis of experiments performed with animals systems, a clinical study was initiated to examine the effect of preoperative BCG-CWP injection in patients with squamous cell carcinomas in the head-neck region. At present, the case study involves 24 patients. The cumulative percentage of patients in complete tumor remission is now 69% for BCG-CWP pretreated tumor patients and 39% for patients who underwent surgery only. The hitherto existing life-table analyses of both therapy groups and the small degree of side effects resulting from BCG-CWP seem to justify a continuation of the study until a statistically confirmed statement can be made about the curative effect of BCG-CWP within the framework of a combination therapy in patients with squamous cell carcinomas in the head-neck region.