Bone Pain Associated with Once-Per-Cycle Pegfilgrastim Is Similar to Daily Filgrastim in Patients with Breast Cancer

• Published in: Clinical breast cancer 2003-02, Vol.3 (6), p.391-398
• Main Authors: Kubista, Ernst, Glaspy, John, Ann Holmes, Frankie, Green, Michael D., Hackett, James, Neumann, Theresa
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Body Weight; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Double-Blind Method; Doxorubicin - administration & dosage; Doxorubicin - adverse effects; Drug Administration Schedule; Female; Filgrastim; Fixed-weight dosing; Granulocyte Colony-Stimulating Factor - administration & dosage; Granulocyte Colony-Stimulating Factor - adverse effects; Granulocyte Colony-Stimulating Factor - analogs & derivatives; Humans; Injections, Subcutaneous; Middle Aged; Multicenter Studies as Topic; Narcotics - therapeutic use; Neoplasm Metastasis; Neutrophil growth factor; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Paclitaxel - analogs & derivatives; Pain - chemically induced; Pain - drug therapy; Pain Measurement; Phase III clinical trial; Polyethylene Glycols; Randomized Controlled Trials as Topic; Recombinant Proteins; Retrospective analysis; Retrospective Studies; Taxoids
• ISSN: 1526-8209; 1938-0666
• DOI: 10.3816/CBC.2003.n.003

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 μg/kg, study 2) to daily filgrastim 5 μg/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-μg/kg doses were administered to 76 and 150 patients, respectively; subcutaneous daily filgrastim 5 μg/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.