Anticipated administration of GM-CSF in the treatment of non small cell lung cancer

The purpose of this study was to verify the kinetic response of the human m arrow myeloid progenitor cells to the short term use of GM-CSF and its impa ct on the therapeutic activity of this three-drug cisplatinum containing re gimen in non small cell lung cancer (NSCLC). Sixty patients with stage III-B and IV NSCLC were randomised to receive GM- CSF for 3 days, five days prior to the onset of chemotherapy. The chemother apy regimen consisted of Mitomycin-C: 6 mg/m(2) on day one, Ifosfamide: 200 0 mg/m(2) days 1 to 3, Mesna: 2000 mg/m(2) days 1 to 3, Cisplatinum: 30 mg/ m2 days I to 3, and was repeated every 4 weeks. All the patients received 30-50 Gy of radiotherapy to the primary and/or me tastatic sites. There were positive correlations between stage of the disea se, chemosensitivity of the tumor, number of chemotherapy cycles and overal l survival (p=0.000). Administration of GM-CSF was an independent prognosti c parameter in locally advanced and metastatic disease (p=0.041). In the GM -CSF receiving arm more courses could be given (117 versus 99, p=0.0415), a nd less courses were postponed (6 versus 22). In this arm, the mean of gran ulocyte nadir was higher (p=0.033) and mean time to granulocyte recovery be came shorter (p=0.001) as the number of chemotherapy cycles increased. It was concluded that, dose intensification with GM-CSF prophylaxis is bene fical in increasing the treatment tolerability by decreasing the intensity of granulocytopenia as well as providing rapid recovery.