I M Bondarenko1, P Bias2, A Buchner3. 1. Dnipropetrovsk State Medical Academy, City Clinical Hospital N 4, 31, Blizhnaya Str, Dnipropetrovsk, 49102, Ukraine. igor.bondarenko@rdp-ukraine.com. 2. Teva Ratiopharm, Graf-Arco-Strasse 3, 89079, Ulm, Germany. 3. Merckle GmbH, Graf-Arco-Strasse 3, 89079, Ulm, Germany.
Abstract
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 receivingdocetaxel 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.
RCT Entities:
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.
Entities:
Keywords:
Bone pain; Docetaxel; Doxorubicin; Drug-related side effect; Lipegfilgrastim; Pegfilgrastim
Authors: Thomas J Smith; James Khatcheressian; Gary H Lyman; Howard Ozer; James O Armitage; Lodovico Balducci; Charles L Bennett; Scott B Cantor; Jeffrey Crawford; Scott J Cross; George Demetri; Christopher E Desch; Philip A Pizzo; Charles A Schiffer; Lee Schwartzberg; Mark R Somerfield; George Somlo; James C Wade; James L Wade; Rodger J Winn; Antoinette J Wozniak; Antonio C Wolff Journal: J Clin Oncol Date: 2006-05-08 Impact factor: 44.544
Authors: Charles L Vogel; Marek Z Wojtukiewicz; Robert R Carroll; Sergei A Tjulandin; Luis Javier Barajas-Figueroa; Brian L Wiens; Theresa A Neumann; Lee S Schwartzberg Journal: J Clin Oncol Date: 2005-02-20 Impact factor: 44.544
Authors: F A Holmes; J A O'Shaughnessy; S Vukelja; S E Jones; J Shogan; M Savin; J Glaspy; M Moore; L Meza; I Wiznitzer; T A Neumann; L R Hill; B C Liang Journal: J Clin Oncol Date: 2002-02-01 Impact factor: 44.544
Authors: Jeffrey J Kirshner; Charles E Heckler; Michelle C Janelsins; Shaker R Dakhil; Judith O Hopkins; Charlotte Coles; Gary R Morrow Journal: J Clin Oncol Date: 2012-04-16 Impact factor: 44.544
Authors: Nicolas André; Maria El Kababri; Pourroy Bertrand; Angelique Rome; Carole Coze; Jean Claude Gentet; Jean Louis Bernard Journal: Anticancer Drugs Date: 2007-03 Impact factor: 2.248
Authors: F A Holmes; S E Jones; J O'Shaughnessy; S Vukelja; T George; M Savin; D Richards; J Glaspy; L Meza; G Cohen; M Dhami; D R Budman; J Hackett; M Brassard; B B Yang; B C Liang Journal: Ann Oncol Date: 2002-06 Impact factor: 32.976
Authors: D Almenar; J Mayans; O Juan; J M Garcia Bueno; J I Jalon Lopez; A Frau; M Guinot; P Cerezuela; E Garcia Buscalla; J A Gasquet; J Sanchez Journal: Eur J Cancer Care (Engl) Date: 2008-12-08 Impact factor: 2.520
Authors: Roberto Guariglia; Maria Carmen Martorelli; Rosa Lerose; Donatella Telesca; Maria Rita Milella; Pellegrino Musto Journal: Biologics Date: 2016-01-22