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Randomized clinical study on intratumoral BCG-cell wall preparation (CWP) therapy in patients with squamous cell carcinoma in the head and neck region
Authors:  rgen Bier, Herb J. Rapp, Tibor Borsos, Bert Zbar, Steve Kleinschuster, Hermann Wagner  Martin Rö  llinghoff
Affiliation:(1) Department of Maxillo-Facial and Plastic Surgery of the Face, Klinikum Steglitz, Free University of West Berlin, Hindenburgdamm 30, 1000 Berlin 45, Federal Republik of Germany;(2) Laboratory of Immunobiology, Division of Cancer Biology and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland;(3) Department of Animal, Dairy and Veterinary Sciences, Utah State University, Logan, Utah, USA;(4) Institute for Medical Microbiology, University of Mainz, Federal Republic of Germany
Abstract:Summary 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. No changes in liver, kidney, or other organ function could be observed after BCG-CWP therapy. Complications and severe secondary effects such as have been described for living BCG were not observed, and significant immunological changes have not been detected so far.
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