PMID- 24485296
OWN - NLM
STAT- MEDLINE
DCOM- 20141118
LR  - 20220317
IS  - 1938-0666 (Electronic)
IS  - 1526-8209 (Linking)
VI  - 14
IP  - 2
DP  - 2014 Apr
TI  - Efficacy and safety of balugrastim compared with pegfilgrastim in patients with 
      breast cancer receiving chemotherapy.
PG  - 101-8
LID - S1526-8209(13)00238-3 [pii]
LID - 10.1016/j.clbc.2013.10.001 [doi]
AB  - BACKGROUND: Recombinant granulocyte colony-stimulating factors (G-CSFs) reduce 
      the incidence and duration of chemotherapy-induced neutropenia and febrile 
      neutropenia when given as adjunct therapy to patients receiving myelosuppressive 
      chemotherapy. Balugrastim is a long-acting G-CSF composed of a genetic fusion 
      between recombinant human serum albumin and G-CSF. We compared the efficacy and 
      safety of balugrastim and pegfilgrastim, a long-acting pegylated recombinant 
      G-CSF, in patients with breast cancer who were scheduled to receive chemotherapy. 
      PATIENTS AND METHODS: In this double-blind randomized phase III trial, patients 
      with >/= 1.5 x 10(9) neutrophils/L were randomly assigned to subcutaneous 
      injections of balugrastim 40 mg (n = 153) or pegfilgrastim 6 mg (n = 151). The 
      primary efficacy end point was the duration of severe neutropenia (DSN) (days 
      with an absolute neutrophil count [ANC] < 0.5 x 10(9) cells/L) during cycle 1. 
      Efficacy analyses were performed in the per-protocol (PP) population. In a 
      separate open-label single-arm study, newly recruited patients (n = 77) received 
      balugrastim 40 mg and were included in the safety analysis. RESULTS: The mean DSN 
      in cycle 1 was 1.1 days in the balugrastim group and 1.0 days in the 
      pegfilgrastim group (95% confidence interval [CI], -0.13-0.37). Two and 4 
      patients, respectively, had febrile neutropenia during cycle 1. Twenty percent of 
      patients in the balugrastim group and 19% in the pegfilgrastim group had adverse 
      events (AEs) considered to be related to study medication; 3.9% and 4.7% of 
      patients, respectively, experienced serious AEs. CONCLUSIONS: This study 
      demonstrates the comparable safety and efficacy profile of balugrastim and 
      pegfilgrastim and the noninferiority of balugrastim for reduction in DSN. There 
      were no unexpected safety events.
CI  - Copyright (c) 2014 Elsevier Inc. All rights reserved.
FAU - Volovat, Constantin
AU  - Volovat C
AD  - Centrul de Oncologie Medicala, Iasi, Romania.
FAU - Gladkov, Oleg A
AU  - Gladkov OA
AD  - Chelyabinsk Regional Clinical Oncology Center, Chelyabinsk, Russia.
FAU - Bondarenko, Igor M
AU  - Bondarenko IM
AD  - Dnipropetrovsk State Medical Academy, Dnipropetrovsk, Ukraine.
FAU - Barash, Steve
AU  - Barash S
AD  - Teva Biopharmaceuticals, Inc, Rockville, MD.
FAU - Buchner, Anton
AU  - Buchner A
AD  - Teva ratiopharm, Ulm, Germany.
FAU - Bias, Peter
AU  - Bias P
AD  - Teva ratiopharm, Ulm, Germany.
FAU - Adar, Liat
AU  - Adar L
AD  - Teva Pharmaceuticals, Inc, Netanya, Israel.
FAU - Avisar, Noa
AU  - Avisar N
AD  - Teva Pharmaceuticals, Inc, Netanya, Israel. Electronic address: 
      noa.avisar@teva.co.il.
LA  - eng
SI  - ClinicalTrials.gov/NCT01126190
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131025
PL  - United States
TA  - Clin Breast Cancer
JT  - Clinical breast cancer
JID - 100898731
RN  - 0 (Recombinant Fusion Proteins)
RN  - 0 (Recombinant Proteins)
RN  - 0 (Serum Albumin)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
RN  - 3A58010674 (pegfilgrastim)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - PVI5M0M1GW (Filgrastim)
RN  - T6K4P3HIU8 (balugrastim)
RN  - ZIF514RVZR (Serum Albumin, Human)
SB  - IM
MH  - Breast Neoplasms/*drug therapy/secondary
MH  - Double-Blind Method
MH  - Female
MH  - Filgrastim
MH  - Follow-Up Studies
MH  - Granulocyte Colony-Stimulating Factor/*therapeutic use
MH  - Humans
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Neoplasm Staging
MH  - Polyethylene Glycols/*chemistry
MH  - Recombinant Fusion Proteins/*therapeutic use
MH  - Recombinant Proteins/therapeutic use
MH  - Safety
MH  - Serum Albumin/*chemistry/therapeutic use
MH  - Serum Albumin, Human
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Balugrastim
OT  - Breast cancer
OT  - Neutropenia
OT  - Pegfilgrastim
OT  - Recombinant granulocyte colony-stimulating factor
EDAT- 2014/02/04 06:00
MHDA- 2014/11/19 06:00
CRDT- 2014/02/04 06:00
PHST- 2013/04/11 00:00 [received]
PHST- 2013/10/11 00:00 [accepted]
PHST- 2014/02/04 06:00 [entrez]
PHST- 2014/02/04 06:00 [pubmed]
PHST- 2014/11/19 06:00 [medline]
AID - S1526-8209(13)00238-3 [pii]
AID - 10.1016/j.clbc.2013.10.001 [doi]
PST - ppublish
SO  - Clin Breast Cancer. 2014 Apr;14(2):101-8. doi: 10.1016/j.clbc.2013.10.001. Epub 
      2013 Oct 25.