Blood, Vol. 93 No. 8 (April 15), 1999:
pp. 2471-2477
Filgrastim for Cladribine-Induced Neutropenic Fever in Patients
With Hairy Cell Leukemia
Alan Saven,
Carol Burian,
Jasvant Adusumalli, and
James A. Koziol
From the Division of Hematology/Oncology, Ida M. and Cecil H. Green
Cancer Center, Scripps Clinic, La Jolla, CA; and The Scripps Research
Institute, La Jolla, CA.
Cladribine treatment of hairy cell leukemia (HCL) is complicated by
neutropenic fever in 42% of patients despite documented infections
being relatively uncommon. We performed a study of priming filgrastim
followed by cladribine and then filgrastim again to determine if
filgrastim would lead to a reduction of neutropenia and febrile
episodes. Thirty-five patients received filgrastim and cladribine and
were compared with 105 historic controls treated with cladribine alone.
Cladribine was administered at 0.1 mg/kg/d by continuous infusion for 7 days. Filgrastim was administered at 5 µg/kg/d subcutaneously on days
3,
2, and
1 and then again after the completion of cladribine
until the absolute neutrophil count (ANC) was
2 × 109/L on 2 consecutive days (days +8, +9, etc). After
filgrastim priming, the median ANC increased from 0.9 × 109/L to 2.26 × 109/L (2.5-fold
increase), and after cladribine, the median nadir ANC in the
filgrastim-treated group was 0.53 × 109/L compared with
0.29 × 109/L among historic controls (P = .04). The median number of days to an ANC greater than 1.0 × 109/L was 9 days in the filgrastim-treated group
versus 22 days among historic controls (P < 10
5). The percentage of febrile patients, number of
febrile days, and frequency of admissions for antibiotics were not
statistically different in the two groups. Filgrastim regularly
increases the ANC in patients with HCL and shortens the duration of
severe neutropenia after cladribine. This phase II study, with
comparison to historical controls, failed to detect any clinical
advantage from the use of filgrastim and cladribine in the treatment of
HCL. Accordingly, the routine adjunctive use of filgrastim with
cladribine in the treatment of HCL cannot be recommended.