PMID- 25877937
OWN - NLM
STAT- MEDLINE
DCOM- 20160125
LR  - 20220409
IS  - 2296-5262 (Electronic)
IS  - 2296-5270 (Linking)
VI  - 38
IP  - 4
DP  - 2015
TI  - Prevention and treatment of chemotherapy-induced neutropenia with the biosimilar 
      filgrastim: a non-interventional observational study of clinical practice 
      patterns.
PG  - 146-52
LID - 10.1159/000381318 [doi]
AB  - BACKGROUND: Biosimilars are similar but non-identical versions of existing 
      biological drugs. The HEXAFIL study was an observational study that assessed the 
      clinical usage, safety and efficacy of the biosimilar filgrastim in routine 
      clinical practice in Germany. PATIENTS AND METHODS: A total of 1,337 cancer 
      patients received the biosimilar filgrastim for primary prophylaxis (PP), 
      secondary prophylaxis (SP) or interventional treatment (TX) plus chemotherapy. 
      Data including neutropenic complications and adverse events (AEs) were documented 
      for up to 3 consecutive cycles. RESULTS: In cycle 1, 44.9% of the patients 
      received the biosimilar filgrastim as PP, 31.0% as SP, and 23.6% as TX. 
      Approximately 90% of the patients required no modifications to their chemotherapy 
      regimen, with lower rates among the PP/SP versus the TX patients. Neutropenic 
      complications occurred in 7.9%, 6.9%, and 3.9% of the patients (cycles 1, 2, and 
      3, respectively). Only 1.8% of the patients experienced febrile neutropenia 
      during cycle 1. Earlier and longer filgrastim treatment reduced grade 3/4 
      leukopenia and neutropenic complications. The observed safety/tolerability 
      profile was as expected; the most common AE (4.3%) was musculoskeletal back/bone 
      pain. CONCLUSION: In this observational real-life study of clinical practice, the 
      biosimilar filgrastim was effective and well tolerated, with results consistent 
      with those reported in phase II and phase III trials. (c) 2015 S. Karger GmbH, 
      Freiburg.
FAU - Tesch, Hans
AU  - Tesch H
AD  - Bethanien Hospital, Frankfurt/M., Germany.
FAU - Ulshofer, Thomas
AU  - Ulshofer T
FAU - Vehling-Kaiser, Ursula
AU  - Vehling-Kaiser U
FAU - Ottillinger, Bertram
AU  - Ottillinger B
FAU - Bulenda, Dietmar
AU  - Bulenda D
FAU - Turner, Matthew
AU  - Turner M
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20150331
PL  - Switzerland
TA  - Oncol Res Treat
JT  - Oncology research and treatment
JID - 101627692
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (Hematologic Agents)
RN  - PVI5M0M1GW (Filgrastim)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*adverse effects/therapeutic use
MH  - Biosimilar Pharmaceuticals/adverse effects/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Filgrastim/adverse effects/*therapeutic use
MH  - Germany
MH  - Hematologic Agents/adverse effects/*therapeutic use
MH  - Humans
MH  - Leukopenia/chemically induced/prevention & control
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/*drug therapy
MH  - Neutropenia/*chemically induced/*drug therapy/prevention & control
MH  - Practice Patterns, Physicians'
MH  - Prospective Studies
MH  - Recurrence
EDAT- 2015/04/17 06:00
MHDA- 2016/01/26 06:00
CRDT- 2015/04/17 06:00
PHST- 2014/09/09 00:00 [received]
PHST- 2015/02/02 00:00 [accepted]
PHST- 2015/04/17 06:00 [entrez]
PHST- 2015/04/17 06:00 [pubmed]
PHST- 2016/01/26 06:00 [medline]
AID - 000381318 [pii]
AID - 10.1159/000381318 [doi]
PST - ppublish
SO  - Oncol Res Treat. 2015;38(4):146-52. doi: 10.1159/000381318. Epub 2015 Mar 31.