ORLANDO—The investigational, single-dose cytokine pegfilgrastim worked as well as filgrastim(Drug information on 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(Drug information on methylprednisolone), cisplatin, and cytarabine(Drug information on cytarabine)) chemotherapy. The objective was to assess the duration of severe neutropenia in cycle 1 and, secondarily, to assess the duration during cycles 2 through 4.
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."
