Randomized clinical study on intratumoral BCG-cell wall preparation (CWP) therapy in patients with squamous cell carcinoma in the head and neck region

Based on animal experiments a clinical study with BCG cell wall preparation (CWP) was developed. Patients with head and neck carcinomas stage T1/2N0–2M0 were randomized. One group received surgical treatment only and a second group received preoperative intralesional BCG-CWP. So far 12 patients have been included in each group. After 3 years the CCR (complete cancer remission) in the surgery only group was 39% and that in the preoperative BCG-CWP group, 69% (P=11%). The cumulative proportion of surviving patients was 50% in the surgery only and 73% in the BCG-CWP group (P=21%). BCG-CWP injection was followed by an increase in body temperature and a decrease in peripheral blood lymphocytes. …