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A
randomized double-blind multicenter phase III study of fixed-dose
single-administration pegfilgrastim versus daily filgrastim in patients
receiving myelosuppressive chemotherapy
Green
MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI,
Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ
Royal
Melbourne and Western Hospitals, Melbourne, Australia
Background.
We evaluated the efficacy of a single fixed 6 mg dose of pegfilgrastim (a
pegylated version of filgrastim) per cycle of chemotherapy, compared with daily
administration of filgrastim, in the provision of neutrophil support.
Patients
and Methods. Patients (n = 157) were randomized to receive either a single 6 mg
subcutaneous (s.c.) injection of pegfilgrastim or daily 5 mg/kg s.c. injections
of filgrastim, after doxorubicin and docetaxel chemotherapy (60 mg/m(2) and 75
mg/m(2), respectively).
Duration of grade 4 neutropenia, depth of neutrophil nadir, incidence of febrile
neutropenia, time to neutrophil recovery and safety information were recorded.
Results.
A single 6 mg injection of pegfilgrastim was as effective as daily injections of
filgrastim for all efficacy measures for all cycles.
The mean duration of grade 4 neutropenia in cycle 1 was 1.8 and 1.6 days for the
pegfilgrastim and filgrastim groups, respectively.
Results for all efficacy end points in cycles 2-4 were consistent with the
results from cycle 1.
A trend towards a lower incidence of febrile neutropenia was noted across all
cycles with pegfilgrastim compared with filgrastim (13% versus 20%,
respectively). A single fixed dose of pegfilgrastim was as safe and well
tolerated as standard daily filgrastim.
Conclusions.
A single fixed dose of pegfilgrastim administered once per cycle of chemotherapy
was comparable to multiple daily injections of filgrastim in safely providing
neutrophil support during myelosuppressive chemotherapy. Pegfilgrastim may have
utility in other clinical settings of neutropenia.
PMID:
12488289 [PubMed - in process]
Source:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12488289&dopt=Abstract
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