Incidence of bone pain in patients with breast cancer treated with lipegfilgrastim or pegfilgrastim: an integrated analysis from phase II and III studies

• Published in: Supportive care in cancer Vol. 24; no. 1; pp. 267 - 273
• Main Authors: Bondarenko, I. M., Bias, P., Buchner, A.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.01.2016; Springer; Springer Nature B.V
• Subjects: Adult; Aged; Anthracyclines; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Arthralgia - chemically induced; Back pain; Back Pain - chemically induced; Bones; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms, Male - drug therapy; Cancer patients; Cancer research; Cancer therapies; Care and treatment; Chemotherapy; Chemotherapy-Induced Febrile Neutropenia - etiology; Comparative analysis; Complications and side effects; Docetaxel; Double-Blind Method; Doxorubicin - administration & dosage; Female; Filgrastim; Granulocyte colony-stimulating factor; Granulocyte Colony-Stimulating Factor - administration & dosage; Granulocyte Colony-Stimulating Factor - adverse effects; Humans; Injections, Subcutaneous; Macrophage colony stimulating factor; Male; Medicine; Medicine & Public Health; Middle Aged; Musculoskeletal Pain - chemically induced; Myalgia - chemically induced; Nursing; Nursing Research; Oncology; Original Article; Pain management; Pain Medicine; Polyethylene Glycols; Recombinant Proteins - administration & dosage; Recombinant Proteins - adverse effects; Rehabilitation Medicine; Side effects; Taxoids - administration & dosage; Pegfilgrastim; Lipegfilgrastim; Drug-related side effect; Doxorubicin; Bone pain; Docetaxel
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-015-2777-7

Purpose Lipegfilgrastim is a once-per-cycle, fixed-dose, glycoPEGylated recombinant granulocyte colony-stimulating factor (G-CSF) recently approved in Europe to reduce the duration of chemotherapy-induced neutropenia and incidence of febrile neutropenia in patients with cancer receiving chemotherapy. Bone pain-related (BPR) adverse events are commonly associated with G-CSF therapy. This post hoc analysis examined BPR treatment-emergent adverse events (TEAEs) in two comparative studies of lipegfilgrastim or pegfilgrastim in patients receiving chemotherapy. Methods A post hoc analysis was conducted using integrated data from two double-blind randomized studies in patients with breast cancer receiving docetaxel and doxorubicin and treated prophylactically with subcutaneous lipegfilgrastim 6 mg or pegfilgrastim 6 mg once per cycle. BPR TEAEs were defined as arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, noncardiac chest pain, and pain in extremity. Relationship of BPR TEAEs to study treatment or chemotherapy was also reported by the investigators. Results The analysis included 306 patients (lipegfilgrastim: n  = 151; pegfilgrastim: n  = 155). The proportion of patients experiencing BPR TEAEs was similar with lipegfilgrastim and pegfilgrastim (25.2 vs 21.9 %, respectively), as was the proportion of patients experiencing BPR treatment-emergent adverse drug reactions (TEADRs) (18.5 vs 16.8 %, respectively). No BPR TEADRs were serious, and none led to discontinuation. Conclusions Nonsevere BPR TEAEs and TEADRs were observed in patients with breast cancer receiving chemotherapy and G-CSF; rates of BPR events were similar between lipegfilgrastim and pegfilgrastim. The similar BPR safety profile of lipegfilgrastim and pegfilgrastim provides support for use in patients with breast cancer receiving chemotherapy.