Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy

Annals of Oncology : Official Journal of the European Society for Medical Oncology
Kimberly BlackwellNadia Harbeck

Abstract

In 2015, the biosimilar filgrastim EP2006 became the first biosimilar approved by the US Food and Drug Administration for commercial use in the United States, marketed as Zarxio® (Sandoz). This phase III randomised, double-blind registration study in patients with breast cancer receiving (neo)adjuvant myelosuppressive chemotherapy (TAC; docetaxel + doxorubicin + cyclophosphamide) compares reference filgrastim, Neupogen® (Amgen), with two groups receiving alternating treatment with reference and biosimilar every other cycle. A total of 218 patients receiving 5 µg/kg/day filgrastim over six chemotherapy cycles were randomised 1: 1: 1: 1 into four arms. Two arms received only one product, biosimilar or reference (unswitched), and two arms (switched) received alternating treatments every other cycle (biosimilar then reference or vice versa over six cycles). Since the switch occurred from cycle 2 onwards, this analysis compared pooled switched groups to the unswitched reference group for efficacy during cycles 2-6. Safety was also assessed. Non-inferiority in febrile neutropenia (FN) rates between groups for cycles 2-6 was shown if 95% were within a pre-defined margin of - 15%. A total of 109 patients switched treatment, and 52 pati...Continue Reading

References

Nov 26, 2010·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·M S AaproUNKNOWN European Organisation for Research and Treatment of Cancer
Sep 29, 2011·Bone Marrow Transplantation·J-C IanottoG Guillerm
Feb 10, 2012·Clinical Pharmacology and Therapeutics·Mark McCamish, Gillian Woollett
Oct 25, 2012·Blood·Martina WeiseChristian K Schneider
Aug 2, 2013·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Pere GascónMatthew Turner
Oct 10, 2014·Blood·Martina WeiseChristian K Schneider
Aug 27, 2015·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Pere GascónIvo Abraham
Apr 28, 2016·Biologicals : Journal of the International Association of Biological Standardization·Jürgen Braun, Alex Kudrin
Sep 27, 2016·Expert Opinion on Biological Therapy·Freddy FaccinTeotonio Albuquerque
Oct 30, 2016·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M AaproI Abraham
Jan 24, 2017·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Carsten BokemeyerKaren MacDonald
Jan 26, 2017·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Pekka KurkiMartina Weise
Feb 25, 2017·Pharmacoepidemiology and Drug Safety·Amy HemmingtonKeith J Petrie

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Citations

Aug 24, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Pere GasconMatti Aapro
Nov 18, 2017·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M Aapro
Sep 22, 2019·Drugs·Pier Luigi ZinzaniGiuseppe Curigliano
Sep 7, 2018·European Journal of Clinical Pharmacology·J O'CallaghanB T Griffin
Apr 10, 2020·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Morgan B FrazerEmma Foreman
Feb 14, 2021·Expert Opinion on Pharmacotherapy·Michele GhidiniGianluca Tomasello

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