Recombinant human interleukin-1 beta: new possibilities for the prophylaxis and correction of toxic myelodepression in patients with malignant tumors. II. Phase II study of the protective effect of recombinant human interleukin-1 beta on myelodepression induced by chemotherapy in cancer patients.

The clinical study of human recombinant IL-1beta as a leukopoiesis protector, administered intravenously and subcutaneously, simultaneously with the chemotherapy, confirmed the "protective" effect of this cytokine in patients with grade II leukopenia induced by previous cycles of chemotherapy. The highly protective effect of IL-1beta was proved by the normalization of absolute peripheral blood granulocyte counts over 5 days, from the start of hemostimulation in patients with leukopenia induced by previous cycles of chemotherapy, despite the continuation of cytostatic treatment. Changing the method of IL-1beta administration from the intravenous to the subcutaneous route had no statistically significant effect on the protective influence of IL-1beta. The time taken for complete restoration of leukopoiesis was almost the same for both methods, 5 +/- 1 days and 7 +/- 1 days for s.c. and i.v. methods respectively. This effect of IL-1beta, not seen in other hematopoietic growth factors such as GM-CSF and G-CSF, allows greater flexibility as regards chemotherapy and provides increased effectiveness of anticancer treatments.