title: A randomized, double-blind trial of pegfilgrastim versus filgrastim for the management of neutropenia during CHASE(R) chemotherapy for malignant lymphoma.
abstract: Pegfilgrastim is a pegylated form of the granulocyte-colony stimulating factor, filgrastim. Herein, we report the results of a multicentre, randomized, double-blind phase III trial comparing the efficacy and safety of pegfilgrastim with filgrastim in patients with malignant lymphoma. Patients were randomized to receive either a single subcutaneous dose of pegfilgrastim or daily subcutaneous doses of filgrastim on day 4 after the completion of cyclophosphamide, cytarabine, etoposide and dexamethasone ± rituximab (CHASE(R); day 1-3) chemotherapy. The primary endpoint was the duration of severe neutropenia (DSN), defined as the number of days with neutrophil count <0·5 × 10(9) /l in the first cycle of chemotherapy. A total of 111 lymphoma patients were randomized to either the pegfilgrastim or filgrastim group. 109 patients received either pegfilgrastim (n = 54) or filgrastim (n = 55). Efficacy data were available for 107 patients (pegfilgrastim: n = 53, filgrastim: n = 54). Both groups were well balanced in terms of gender, age, performance status and other variables. The mean DSN (±S.D.) was 4·5 (±1·2) and 4·7 (±1·3) d in the pegfilgrastim and filgrastim groups. No significant difference in safety was observed. This trial verified the non-inferiority of a single subcutaneous dose of pegfilgrastim compared with daily subcutaneous doses of filgrastim, considering DSN as an indicator.
authors.affiliation: Department of Haematology, Aomori Prefectural Central Hospital, Aomori, Japan.
authors.forename: Kohmei
authors.initials: K
authors.lastname: Kubo
authors.affiliation: Department of Haematology, Oita Prefectural Hospital, Oita, Japan.
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Miyazaki
authors.affiliation: Department of Haematology, Hyogo Cancer Centre, Hyogo, Japan.
authors.forename: Tohru
authors.initials: T
authors.lastname: Murayama
authors.affiliation: R&D Division, Kyowa Hakko Kirin Co. Ltd, Tokyo, Japan.
authors.forename: Ryutaro
authors.initials: R
authors.lastname: Shimazaki
authors.affiliation: Department of Clinical Oncology and Haematology, The Jikei University Daisan Hospital, Tokyo, Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Usui
authors.affiliation: NTT Medical Centre Tokyo, Tokyo, Japan.
authors.forename: Akio
authors.initials: A
authors.lastname: Urabe
authors.affiliation: National Cancer Centre, Tokyo, Japan.
authors.forename: Tomomitsu
authors.initials: T
authors.lastname: Hotta
authors.affiliation: Division of Medical Oncology, Haematology and Infectious Disease, Fukuoka University, Fukuoka, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Tamura
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use; D003561:Cytarabine / Q000009:adverse effects / Q000627:therapeutic use; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use; D019468:Disease Management; D004311:Double-Blind Method; D005047:Etoposide / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D000069585:Filgrastim / Q000008:administration & dosage*; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008223:Lymphoma / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000188:drug therapy*; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000008:administration & dosage; D000069283:Rituximab / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069283:Rituximab; D005047:Etoposide; D003907:Dexamethasone; D003520:Cyclophosphamide; D000069585:Filgrastim
keywords: CHASE(R) chemotherapy; G-CSF; febrile neutropenia; malignant lymphoma; pegfilgrastim