title: Fixed-dose pegfilgrastim is safe and allows neutrophil recovery in patients with non-Hodgkin's lymphoma.
abstract: Twenty-nine patients with non-Hodgkin's lymphoma received a single subcutaneous injection of 6 mg pegfilgrastim approximately 24 h after the start of CHOP chemotherapy. The safety of pegfilgrastim in this patient population was determined by reports of adverse events. The pharmacokinetics of pegfilgrastim were characterized and the duration of grade 4 neutropenia, time to absolute neutrophil count (ANC) recovery to > or = 2.0 x 10(9)/l, neutrophil nadir, and incidence of febrile neutropenia were determined in the first 21-day chemotherapy cycle. The incidence of grade 4 neutropenia in cycle 1 was 43% with a mean (SD) duration of grade 4 neutropenia value of 1.0 (1.4) day. No apparent relationship between the duration of grade 4 neutropenia and body weight was observed. The median [quartiles] time to ANC recovery was 10 [9, 11] days. The incidence of febrile neutropenia was 11%. No unexpected adverse events were reported and no patient developed antibodies to pegfilgrastim. Serum concentration of pegfilgrastim reached a maximum (median [quartiles]) of 128 [58, 159] ng/ml at approximately 24 h after administration, and was followed by a second smaller peak (median [quartiles]) of 10.6 [3.0, 20.5] ng/ml at the time of the neutrophil nadir. After the second peak, concentration of pegfilgrastim declined linearly with a median terminal half-life of approximately 42 h.
authors.affiliation: Cancer and Blood Institute of the Desert, 39700 Bob Hope Drive, Suite 110 Rancho Mirage, CA 92270-7103, USA.
authors.forename: S
authors.initials: S
authors.lastname: George
authors.forename: F
authors.initials: F
authors.lastname: Yunus
authors.forename: D
authors.initials: D
authors.lastname: Case
authors.forename: B B
authors.initials: BB
authors.lastname: Yang
authors.forename: J
authors.initials: J
authors.lastname: Hackett
authors.forename: J E
authors.initials: JE
authors.lastname: Shogan
authors.forename: L A
authors.initials: LA
authors.lastname: Meza
authors.forename: T A
authors.initials: TA
authors.lastname: Neumann
authors.forename: B C
authors.initials: BC
authors.lastname: Liang
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000627:therapeutic use; D004317:Doxorubicin / Q000627:therapeutic use; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D009504:Neutrophils / Q000502:physiology*; D011092:Polyethylene Glycols; D011241:Prednisone / Q000627:therapeutic use; D011994:Recombinant Proteins; D012449:Safety; D016896:Treatment Outcome; D014750:Vincristine / Q000627:therapeutic use
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D000069585:Filgrastim; D011241:Prednisone