title: Bone pain associated with once-per-cycle pegfilgrastim is similar to daily filgrastim in patients with breast cancer.
abstract: Bone pain is a common side effect of treatment with filgrastim. Pegfilgrastim is a pegylated long-acting analogue of filgrastim that is administered once per chemotherapy cycle. The profile of prospectively defined, patient-reported bone pain judged by the investigators as related to study drug was analyzed retrospectively for each drug using data from two comparable phase III trials. These multicenter, randomized, double-blind, noninferiority trials compared once-per-cycle pegfilgrastim (6 mg, study 1 or 100 microg/kg, study 2) to daily filgrastim 5 microg/kg in patients with stage II-IV breast cancer undergoing multiple cycles of myelosuppressive chemotherapy (doxorubicin/docetaxel). Subcutaneous once-per-cycle pegfilgrastim 6-mg and 100-microg/kg doses were administered to 76 and 150 patients, respectively; subcutaneous daily filgrastim 5 microg/kg was administered to a total of 227 patients. Because bone pain in study 1 was higher (P = 0.044) in every cycle compared with study 2, all analyses were performed separately for each study. No statistically significant differences in incidence, severity, or duration were observed between patients receiving either once-per-cycle pegfilgrastim or daily filgrastim in either study. Bone pain incidence and severity were significantly greater (P < 0.001) in cycle 1 of both studies compared with later cycles. Among patients with bone pain, a trend towards earlier onset with pegfilgrastim was observed but was not associated with increased bone pain severity or duration. In patients who received a fixed 6-mg dose of pegfilgrastim, the overall bone pain incidence was similar when analyzed by body weight (< 60 kg, 60-100 kg, > 100 kg). No patients were withdrawn from either study for bone pain.
authors.affiliation: General Hospital Vienna, Austria. ernst.kubista@akh-wien.ac.at
authors.forename: Ernst
authors.initials: E
authors.lastname: Kubista
authors.forename: John
authors.initials: J
authors.lastname: Glaspy
authors.forename: Frankie Ann
authors.initials: FA
authors.lastname: Holmes
authors.forename: Michael D
authors.initials: MD
authors.lastname: Green
authors.forename: James
authors.initials: J
authors.lastname: Hackett
authors.forename: Theresa
authors.initials: T
authors.lastname: Neumann
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001835:Body Weight; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000077143:Docetaxel; D004311:Double-Blind Method; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects* / Q000031:analogs & derivatives; D006801:Humans; D007279:Injections, Subcutaneous; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009294:Narcotics / Q000627:therapeutic use; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010146:Pain / Q000139:chemically induced* / Q000188:drug therapy; D010147:Pain Measurement; D011092:Polyethylene Glycols; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins; D012189:Retrospective Studies; D043823:Taxoids
chemical_list: D009294:Narcotics; D011994:Recombinant Proteins; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D004317:Doxorubicin; D017239:Paclitaxel; D000069585:Filgrastim