RECOMBINANT HUMAN GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR AFTER COMBINED CHEMOTHERAPY IN HIGH-GRADE NON-HODGKINS-LYMPHOMA - A RANDOMIZED PILOT-STUDY

High-grade non-Hodgkin's lymphomas (NHL) can potentially be cured with combination chemotherapy, although the optimum schedules still have t o be defined. Clinical trials with intensive chemotherapy are predomin antly limited by myelosuppression. Here, haematopoetic growth factors open up the possibility of reducing chemotherapy-associated toxicities . In this randomised pilot study, we investigated the effects of a rec ombinant human granulocyte-macrophage colony-stimulating factor (rhGM- CSF) following combined chemotherapy with vincristine, doxorubicin, cy clophosphamide, prednisone and etoposide (VACPE). A total of 35 patien ts with high-grade NHLs were randomised to receive either rhGM-CSF or placebo during the first two chemotherapy cycles and rhGM-CSF for all following cycles. rhGM-CSF was administered at a dosage of 5 mu g/kg f or 10 days or until neutrophils were >1/nl following chemotherapy. The analyses revealed a significant reduction of neutropenia and duration of neutropenia in the rhGM-CSF group. Adverse events were rare and ge nerally mild apart from one anaphylactoid reaction. No effects of rhGM -CSF were observed concerning the platelet nadir or duration of thromb ocytopenia. The benefit of rhGM-CSF for response induction and surviva l via rhCM-CSF-supported dose intensification remains to be determined .