ORLANDOThe investigational, single-dose cytokine pegfilgrastim
worked as well as filgrastim (G-CSF, Neupogen) in decreasing the duration of
severe neutropenia following chemotherapy in patients with relapsed or
refractory non-Hodgkin’s lymphoma (NHL) or Hodgkin’s disease.
Lead investigator Julie M. Vose, MD, professor of medicine, University of
Nebraska Medical Center, reported the results at the 43rd Annual Meeting of the
American Society of Hematology (abstract 3322).
Pegfilgrastim is formulated by adding a polyethylene glycol molecule or
"PEG" unit to enlarge the parent filgrastim molecule, causing it to
be removed more slowly from the body. This allows an extended half-life, so
that a single injection after each chemotherapy cycle is all that is needed.
Filgrastim circulates in the blood for a relatively short time, necessitating
daily injections for up to 2 weeks following each chemotherapy cycle.
During a multicenter, phase II trial, investigators compared the efficacy of
the two drugs in patients with relapsed or refractory Hodgkin’s disease or
NHL who received ESHAP (etoposide, methylprednisolone, cisplatin, and
cytarabine) chemotherapy. The objective was to assess the duration of severe
neutropenia in cycle 1 and, secondarily, to assess the duration during cycles 2
Patients were randomized to receive pegfilgrastim, 100 µg/kg, on the day
after chemotherapy (29 patients) or filgrastim, 5 µg/kg/d, on the day after
chemotherapy and continuing for 12 days or until neutrophil recovery (ANC
greater than 10,000/µL) (31 patients). In cycle 1, the median number of
filgrastim injections was 11 (range, 9 to 15).
Twenty-two patients in the pegfilgrastim arm and 28 in the filgrastim arm
went on to receive cycle 2. Again, the median number of filgrastim doses
received was 11.
"There was no difference in the incidence of severe neutropenia by
randomization arm for cycle 1 or 2," Dr. Vose said. "The level of
severe neutropenia was approximately 70% in cycle 1, compared with about 25% to
30% in cycle 2."