title: Efficacy and safety of lipegfilgrastim compared with placebo in patients with non-small cell lung cancer receiving chemotherapy: post hoc analysis of elderly versus younger patients.
abstract: Lipegfilgrastim, a glycoPEGylated recombinant granulocyte colony-stimulating factor (G-CSF), reduces neutropenia duration and febrile neutropenia (FN) incidence in patients with cancer receiving myelosuppressive chemotherapy. A phase 3 trial of lipegfilgrastim was conducted in patients with advanced non-small cell lung cancer (NSCLC) receiving cisplatin/etoposide (which produces mild-to-moderate myelosuppression). Because patients aged >65 years are at higher risk for FN versus younger patients, this post hoc analysis compared outcomes in elderly (>65 years) versus younger participants in this trial.
  
  
  
  Patients were randomized 2:1 to receive a once-per-cycle single subcutaneous injection of lipegfilgrastim 6 mg or placebo, with up to 4 cycles of every-3-week cisplatin (day 1) and etoposide (days 1-3). The primary end point was FN incidence during cycle 1. Outcomes were compared across treatment groups and by age groups (≤65 and >65 years).
  
  
  
  For patients aged ≤65 years, FN incidence during cycle 1 was similar in the lipegfilgrastim and placebo groups (3.0 vs 3.2 %, respectively), whereas for elderly patients, there was a reduction in FN incidence with lipegfilgrastim (0 vs 13.3 %, respectively). In both age subgroups, lipegfilgrastim showed a propensity to reduce the incidence and duration of severe neutropenia, time to absolute neutrophil count (ANC) recovery, and depth of ANC nadir. Adverse events were generally similar between groups.
  
  
  
  This analysis suggests that in patients with a higher FN risk, such as the elderly patients of this study, lipegfilgrastim reduces not only the duration of severe neutropenia but also the incidence of FN.
authors: Centrul de Oncologie Medicala, Vasile Conta 2 Str, 700106, Iasi, Romania. cvolovat@yahoo.com.
authors: Constantin
authors: C
authors: Volovat
authors: Dnipropetrovsk State Medical Academy, City Clinical Hospital N 4, 31, Blizhnaya str, Dnipropetrovsk, 49102, Ukraine.
authors: Igor
authors: I
authors: Bondarenko
authors: Chelyabinsk Regional Clinical Oncology Dispensary, 42, Blukhera str, Chelyabinsk, Russian Federation, 454087.
authors: Oleg
authors: O
authors: Gladkov
authors: Teva ratiopharm, Merckle GmbH, Graf-Arco-Strasse 3, 89079, Ulm, Germany.
authors: Anton
authors: A
authors: Buchner
authors: Teva ratiopharm, Merckle GmbH, Graf-Arco-Strasse 3, 89079, Ulm, Germany.
authors: Andreas
authors: A
authors: Lammerich
authors: Teva ratiopharm, Merckle GmbH, Graf-Arco-Strasse 3, 89079, Ulm, Germany.
authors: Udo
authors: U
authors: Müller
authors: Teva ratiopharm, Merckle GmbH, Graf-Arco-Strasse 3, 89079, Ulm, Germany.
authors: Peter
authors: P
authors: Bias
mesh_terms: D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim
keywords: Elderly; Neutropenia; Non-small cell lung cancer; Phase 3 clinical trial; Recombinant granulocyte colony-stimulating factor