title: Chemotherapy-associated treatment burden in breast cancer patients receiving lipegfilgrastim or pegfilgrastim: secondary efficacy data from a phase III study.
abstract: OBJECTIVE
  Lipegfilgrastim is a once-per-cycle glycoPEGylated granulocyte colony-stimulating factor (G-CSF). Noninferiority of lipegfilgrastim versus pegfilgrastim was demonstrated in a phase III trial in chemotherapy (CTx)-naïve breast cancer patients. Secondary outcomes relating to treatment burden are reported here.
  
  
  METHODS
  Patients with high-risk stage II, III, or IV breast cancer were randomized to receive lipegfilgrastim 6 mg (n = 101) or pegfilgrastim 6 mg (n = 101) subcutaneously on day 2 of each CTx cycle. Doxorubicin 60 mg/m(2) plus docetaxel 75 mg/m(2) commenced on day 1, for up to four cycles. Secondary end points included days in the hospital or intensive care unit (ICU), use of intravenous antibiotics for febrile neutropenia (FN) or related infections, and measures of CTx delivery (dose delays, reductions, and omissions).
  
  
  RESULTS
  One lipegfilgrastim recipient and two pegfilgrastim recipients were hospitalized in cycle 1 because of FN or associated infection. The lipegfilgrastim-treated patient spent 1 day in the ICU for FN, and the two pegfilgrastim-treated patients were hospitalized for FN for 5 and 6 days, respectively. All hospitalized patients received antibiotics. An additional pegfilgrastim-treated patient received antibiotics but was not hospitalized. Most patients received CTx as scheduled; over 98% received their planned doxorubicin and docetaxel doses in all cycles. In the lipegfilgrastim group, no patients had a CTx dose reduced or omitted; eight patients in the pegfilgrastim group had a CTx dose reduced or omitted during cycles 2-4.
  
  
  CONCLUSIONS
  The burden of treatment associated with myelosuppressive CTx was similar in breast cancer patients treated with lipegfilgrastim or pegfilgrastim.
authors.affiliation: Chelyabinsk Regional Clinical Oncology Dispensary, 42 Blukhera str, Chelyabinsk, 454087, Russian Federation. gladkov_o@rambler.ru.
authors.forename: Oleg A
authors.initials: OA
authors.lastname: Gladkov
authors.affiliation: Merckle GmbH, Graf-Arco-Strasse 3, 89079, Ulm, Germany.
authors.forename: Anton
authors.initials: A
authors.lastname: Buchner
authors.affiliation: Teva Ratiopharm, Graf-Arco-Strasse 3, 89079, Ulm, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Bias
authors.affiliation: Teva Ratiopharm, Graf-Arco-Strasse 3, 89079, Ulm, Germany.
authors.forename: Udo
authors.initials: U
authors.lastname: Müller
authors.affiliation: Teva Ratiopharm, Graf-Arco-Strasse 3, 89079, Ulm, Germany.
authors.forename: Reiner
authors.initials: R
authors.lastname: Elsässer
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy*; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000209:etiology; D017281:Cost of Illness; D003422:Critical Care / Q000706:statistics & numerical data; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012307:Risk Factors; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D011994:Recombinant Proteins; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D004317:Doxorubicin; D000069585:Filgrastim
keywords: Antibiotics; Breast neoplasms; Febrile neutropenia; Granulocyte colony-stimulating factor; Hospitalization