Tumor necrosis factor in advanced gastrointestinal neoplasms. A clinical trial with a focus on haematological effects

This paper presents the results of the clinical trial with the use of hr TNF-alpha (human recombinant tumor necrosis factor-alpha) in 16 advanced gastrointestinal cancer patients. Hr TNF-alpha was administered intravenously in a short, 30-min infusion. According to authors' previous experiences with daily dose escalation (modified Fibonacci scheme), a daily dose of 150 microg/m2 was established as safe, and was well tolerated by the patients. The treatment consisted of 5-day cycles, repeated six times, every 14 days. Special attention was paid regarding the possible side-effect and safety of hr TNF-alpha administration in men, as many acute and chronic haematological toxicities have been reported. After careful analysis of TNF-alpha side-effects, we did not find any acute haematological complications (e.g. thrombosis, DIC, embolism) in any of the patients. Haemoglobin values and erythrocyte and leucocyte counts gradually decreased during each cycle, with the tendency for spontaneous renewal after the treatment had been completed. No cases of thrombocytopenia and severe neuropenia were observed.