[A clinical study of recombinant human G-CSF in gynecological tumor patients with neutropenia due to chemotherapy (rG.CSF Clinical Study Group)].
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.
Department of Obstetrics and Gynecology, Jikei University School of Medicine.
Y
Y
Terashima
K
K
Ochiai
M
M
Hashimoto
I
I
Nishiya
H
H
Takamizawa
K
K
Hasumi
M
M
Takada
K
K
Akiya
Y
Y
Negishi
Y
Y
Takeda
D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D004341:Drug Evaluation; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy*; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000628:therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor