Abstract
In five clinical trials AM3, a polysaccharide/protein biological response modifier, was given (3 g/day; two capsules, tid) to 79 breast cancer patients undergoing adjuvant radio- and/or chemotherapies. When compared with 68 control patients, AM3 provoked significant decreases in the incidence of bone-marrow hypoplasia (20.5% versus 61.1%). This marrow effect was also manifested in peripheral blood by higher levels of white blood cells, mononuclear cells and platelets in the AM3 treated group. The incidence of thrombocytopenia in patients receiving combined radio-chemotherapy only was 70% compared with 6% observed in patients also receiving AM3 treatment. Besides these hematological effects, AM3 palliated subclinical hepatic toxicity due to combined radio-chemotherapy. Finally, studies on acute-phase reactants, such as C-reactive protein, IgA. and factors B, C'3, and C'5 of the complement system, suggest that a modulation of hepatic inflammatory responses by AM3 appears to be essential for clinical effects described.