Fludarabine and granulocyte colony-stimulating factor (G-CSF) in patients with chronic lymphocytic leukemia.
The study was designed to determine whether administration of granulocyte colony-stimulating factor (G-CSF) following fludarabine would reduce the incidences of myelosuppression and infections. Twenty-five previously treated patients with Rai stage III-IV chronic lymphocytic leukemia (CLL) received fludarabine 30 mg/m2 daily for 5 days each month. G-CSF was given at 5 microg/kg subcutaneously starting 1 day after chemotherapy (day 6) and continued until the next course unless the granulocyte count was > or =10000/microl. The incidences of myelosuppression and infection were compared with those seen in an historical control population of 145 previously treated patients with Rai stage III-IV CLL who were given the same schedule of fludarabine without growth factor. There was a significant decrease in myelosuppression; patients receiving G-CSF developed neutropenia at a neutrophil count <1000/microl or 500/microl in 45% and 15% of courses vs 79% (P=0.002) and 63% (P < 0.001) of historical controls. Twenty percent of G-CSF-treated patients had therapy delayed by >35 days per course, vs 50% of historical controls (P=0.005). The incidence of pneumonia was 8% with G-CSF and 37% without in historical controls. Other infection rates (sepsis, fever of undetermined origin, minor infections) were similar. This decrease in pneumonia was noted even in high-risk groups such as patients older than 60 years and patients with hypogammaglobulinemia. The use of G-CSF following fludarabine in high-risk patients with CLL resulted in a significant decrease in myelosuppression and pneumonia. Larger trials to verify these results and to compare costs are indicated.
O'Brien
S
S
Department of Hematology, The University of Texas MD Anderson Cancer Center, Houston 77030, USA.
Kantarjian
H
H
Beran
M
M
Koller
C
C
Talpaz
M
M
Lerner
S
S
Keating
M J
MJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005334:Fever / Q000209:etiology / Q000382:microbiology; D016905:Gram-Negative Bacterial Infections / Q000209:etiology / Q000517:prevention & control; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000097:blood / Q000188:drug therapy*; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000150:complications / Q000382:microbiology; D014740:Vidarabine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000970:Antineoplastic Agents; D016179:Granulocyte Colony-Stimulating Factor; D014740:Vidarabine; C024352:fludarabine