RHGM-CSF AMELIORATES NEUTROPENIA IN PATIENTS WITH MALIGNANT GLIOMA TREATED WITH BCNU

Nitrosoureas are the drugs most effective in the treatment of patients with intracerebral malignant glioma. Their limiting toxicity is delay ed myelosuppression. A prospective, randomised crossover study of reco mbinant human granulocyte-macrophage colony-stimulating factor (rhGM-C SF) was performed in patients receiving BCNU for relapsed glioblastoma , to investigate whether the resulting haematological toxicity profile could be modified by rhGM-CSF. Adequate data for analysis were obtain ed in 13 patients. Following BCNU, the nadir neutrophil count was high er in 12 out of 13 patients during the rhGM-CSF-protected cycles compa red with the unprotected cycles. The median nadir was also significant ly higher (1.79, CI 0.76-3.52, P<0.005). Five episodes of neutropenia (<2 x 10(9) l(-1)) occurred during the unprotected cycles compared wit h none in the rhGM-CSF-protected cycles (P = 0.076). There was no evid ence of any effect on platelets. This result shows that the haematolog ical toxicity profile following therapeutic doses of BCNU can be modif ied. It suggests that rhGM-CSF and other growth factors should be inve stigated for clinical efficacy in chemotherapy using nitrosoureas.