A clinical study of recombinant human G-CSF in gynecological tumor patients with neutropenia due to chemotherapy (rG.CSF Clinical Study Group)

Abstract:  We evaluated clinical efficacy of recombinant human granulocyte colony stimulating factor (rG-CSF), successfully expressed in Chinese hamster ovarian cell, in gynecological tumor patients (pts) with neutropenia due to chemotherapy (CT). Fifty-eight pts with advance or relapsed gynecological malignancy were entered into this study. These pts had neutropenia below 1,000/cmm by CT and in the next cycle of CT they were treated with daily rG-CSF (2 micrograms/kg/day, subcutaneously) starting from the next day of CT for 14 days. The activities of rG-CSF were evaluated using following indices calculated for each cycle: a) the absolute neutrophil count (ANC) at nadir, b) the period for restoration in ANC above 1,500/cmm, and c) the total area below the 1,000/cmm level in ANC calculated by a computer. Forty-seven out of 52 evaluable pts (90.4%) showed good response to rG-CSF. Only adverse events considered possibly due to rG-CSF were transient fever and anorexia, one case each. In conclusion, rG-CSF appears to be well tolerated by gynecological tumor patients and to considerably rescue them from neutropenia caused by intensive chemotherapy.