PRIMING AND TREATMENT WITH MOLGRAMOSTIM (RHGM-CSF) IN ADULT HIGH-RISKACUTE MYELOID-LEUKEMIA DURING INDUCTION CHEMOTHERAPY - A PROSPECTIVE,RANDOMIZED PILOT-STUDY

In a randomized study of 18 adult patients with high-risk or advanced acute myeloid leukemia (AML) we investigated the effect of supplementi ng conventional induction chemotherapy with recombinant human granuloc yte-macrophage colony-stimulating factor (rhGM-CSF). For comparison, a historical control group of 90 patients treated for de novo AML with conventional chemotherapy during the previous period, 1984-1990, was a lso analyzed. Before induction chemotherapy, 10 patients were randomiz ed to receiving rhGM-CSF, starting on day 1 to 3 before chemotherapy a nd continued for a maximum of 21 days after the start of induction tre atment. Fatal complications and treatment outcome did not differ betwe en the study groups and historical controls. Nor were there any differ ences between the groups in terms of hematological toxicity, e.g. time to three-lineage regeneration and need for supportive therapy. Howeve r, sequential weekly bone marrow examinations revealed a prolonged red uction of the relative number of myeloid (CD33-positive) marrow cells in the rhGM-CSF treated group. Although the small number of patients s tudied may not permit a definite conclusion, this randomized study did not demonstrate major beneficial effects of combining rhGM-CSF with s tandard induction chemotherapy in high-risk patients with AML.