EFFECT OF GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) ON HEMATOLOGIC TOXICITY INDUCED BY HIGH-DOSE CHEMOTHERAPY IN PATIENTS WITH METASTATIC BREAST-CANCER

Twenty patients with recurrent metastatic breast cancer treated with high-dose myelosuppressive antineoplastic drugs (cyclophosphamide 2.5 g/m(2) or epirubicin 130 mg/m(2), both every 3 weeks) as first or second line chemotherapy were randomized in a prospective study to GM-CSF 5 mu g/kg per day (n = 11) or control (n = 9). Significant reduction in granulocyte nadir duration (2 days with GM-CSF vs, 7 days) and severity (0.4 x 10(9)/l with GM-CSP vs, 0.2 x 10(9)/l) was found, No difference in frequency of neutropenic fever or antibiotic use could be observed, Even though the patients treated with GM-CSF at random were more heavily pretreated with chemotherapy, there was a surprisingly higher response rate in these patients as compared to the control-arm, namely 64% vs, 28.5%, However, this difference was not statistically significant, No severe side-effects were seen, but presumably due to GM-CSF one patient developed an allergic type 1 reaction and one patient a possible pericardial exudation. Both were fully reversible after cessation of the cytokine treatment.