The purpose of this study was to verify the kinetic response of the human marrow myeloid progenitor cells to the short term use of
GM-CSF and its impact on the therapeutic activity of this three-
drug cisplatinum containing regimen 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
chemotherapy regimen consisted of
Mitomycin-C: 6 mg/m2 on day one,
Ifosfamide: 2000 mg/m2 days 1 to 3,
Mesna: 2000 mg/m2 days 1 to 3, Cisplatinum: 30 mg/m2 days 1 to 3, and was repeated every 4 weeks. All the patients received 30-50 Gy of
radiotherapy to the primary and/or metastatic sites. There were positive correlations between stage of the disease, chemosensitivity of the
tumor, number of
chemotherapy cycles and overall survival (p=0.000). Administration of
GM-CSF was an independent prognostic 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), and less courses were postponed (6 versus 22). In this arm, the mean of granulocyte nadir was higher (p=0.033) and mean time to granulocyte recovery became shorter (p=0.001) as the number of
chemotherapy cycles increased. It was concluded that, dose intensification with
GM-CSF prophylaxis is benefical in increasing the treatment tolerability by decreasing the intensity of
granulocytopenia as well as providing rapid recovery.