RECOMBINANT HUMAN GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (RHGM-CSF) AFTER CHEMOTHERAPY IN PATIENTS WITH NON-HODGKINS-LYMPHOMA - APLACEBO-CONTROLLED DOUBLE-BLIND PHASE-III TRIAL

To assess the clinical and hematopoietic effects of rhGM-CSF, a placeb o-controlled double blind multicenter phase III study was undertaken i n patients with non-Hodgkin's lymphoma receiving cytotoxic chemotherap y. Sixty-two patients who had granulocytopenia (< 1 x 10(3)/mul) after the first cycle of chemotherapy with cyclophosphamide, adriamycin, vi ncristine, and prednisolone were enrolled. After the second cycle of c hemotherapy with the same regimen, patients randomly received either r hGM-CSF (125 mug/m2/day) or placebo for 14 days (rhGM-CSF; 31 patients and placebo; 31 patients). Administration of rhGM-CSF induced a signi ficant increase in granulocytes mainly with neutrophils, eosinophils a nd monocytes, but elevation of lymphocytes, platelets, and reticulocyt es was not induced. Median days of granulocytes less than 1 x 10(3)mul in patients receiving rhGM-CSF were significantly shorter than in pat ients receiving placebo (p = 0.001). Adverse reactions encountered wit h rhGM-CSF, and observed in 58% of the patients were never life-threat ening and always rapidly reversible. They included fever, nausea and v omiting, diarrhea, skin eruption, and malaise. These results suggest t hat rhGM-CSF can be safely administered to prevent neutropenia after c hemotherapy in patients with non-Hodgkin's lymphoma.