title: Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.
abstract: OBJECTIVE
  This randomized, double-blind trial compared proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer (PROTECT-1).
  
  
  METHODS
  Women (≥18 years) were randomized to receive LA-EP2006 (n = 159) or reference (n = 157) pegfilgrastim (Neulasta(®), Amgen) for ≤6 cycles of (neo)-adjuvant TAC chemotherapy. Primary end point was duration of severe neutropenia (DSN) during cycle 1 (number of consecutive days with absolute neutrophil count <0.5 × 10(9)/l) with equivalence confirmed if 90% and 95% CIs were within a ±1 day margin.
  
  
  RESULTS
  For DSN, LA-EP2006 was equivalent to reference (difference: 0.07 days; 90% CI: -0.09-0.23; 95% CI: -0.12-0.26).
  
  
  CONCLUSIONS
  LA-EP2006 and reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy.
authors.affiliation: Breast Center & CCCLMU, University of Munich, Munich, Germany.
authors.forename: Nadia
authors.initials: N
authors.lastname: Harbeck
authors.affiliation: Republican Clinical Oncology Dispensary of the Ministry of Public Health of Bashkortostan Republic, Ufa, Russia.
authors.forename: Oleg
authors.initials: O
authors.lastname: Lipatov
authors.affiliation: Russian Oncology Research Center n.a. N.N. Blochin of RAMS, Moscow, Russia.
authors.forename: Mona
authors.initials: M
authors.lastname: Frolova
authors.affiliation: Oncological Dispensary #2 of Healthcare Department of Krasnodar Territory, Krasnodar, Russia.
authors.forename: Dmitry
authors.initials: D
authors.lastname: Udovitsa
authors.affiliation: Northwest State Medical University n.a. I.I. Mechnikov, St Petersburg, Russia.
authors.forename: Eldar
authors.initials: E
authors.lastname: Topuzov
authors.affiliation: Spitalul Judetean de Urgenta, Suceava, Romania.
authors.forename: Doina Elena
authors.initials: DE
authors.lastname: Ganea-Motan
authors.affiliation: Hexal AG (a Sandoz company), Holzkirchen, Germany.
authors.forename: Roumen
authors.initials: R
authors.lastname: Nakov
authors.affiliation: Hexal AG (a Sandoz company), Holzkirchen, Germany.
authors.forename: Pritibha
authors.initials: P
authors.lastname: Singh
authors.affiliation: Hexal AG (a Sandoz company), Holzkirchen, Germany.
authors.forename: Anita
authors.initials: A
authors.lastname: Rudy
authors.affiliation: Duke University, DUMC, NC, USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Blackwell
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000494:pharmacology* / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim
keywords: biosimilars; granulocyte-colony-stimulating factor; pegfilgrastim