PMID- 26155455
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150709
LR  - 20201001
IS  - 2193-1801 (Print)
IS  - 2193-1801 (Electronic)
IS  - 2193-1801 (Linking)
VI  - 4
DP  - 2015
TI  - Phase III, randomized, double-blind, placebo-controlled, multicenter study of 
      lipegfilgrastim in patients with non-small cell lung cancer receiving 
      myelosuppressive therapy.
PG  - 316
LID - 10.1186/s40064-015-1067-7 [doi]
LID - 316
AB  - PURPOSE: The aim of this study was to demonstrate lipegfilgrastim superiority 
      versus placebo in adults with non-small cell lung cancer receiving 
      myelosuppressive chemotherapy. METHODS: This phase III, double-blind study 
      randomized chemotherapy-naive patients to receive cisplatin and etoposide with 
      either lipegfilgrastim 6 mg or placebo. Because of the placebo control, patients 
      at individual high risk for febrile neutropenia (FN; >/=20%) were excluded. Study 
      drug was administered on day 4 (24 h after chemotherapy) of a 21-day cycle for </=4 
      cycles. Primary efficacy measure was FN incidence in cycle 1. Secondary 
      assessments included duration of severe neutropenia (DSN), absolute neutrophil 
      count (ANC) profile, and adverse events (AEs). RESULTS: The study included 375 
      patients (lipegfilgrastim, n = 250; placebo, n = 125). Lipegfilgrastim 
      superiority for FN incidence in cycle 1 was not achieved but incidence was lower 
      (2.4%) versus placebo (5.6%). Cycle 1 mean DSN was significantly shorter for 
      lipegfilgrastim (0.6 +/- 1.1 days) versus placebo (2.3 +/- 0.5 days; p < 0.0001). 
      Incidence of severe neutropenia was significantly lower for lipegfilgrastim 
      versus placebo overall and in each cycle (all, p < 0.0001). Mean ANC nadir was 
      lowest in cycle 1 but significantly higher for lipegfilgrastim (1.60 +/- 1.64) than 
      placebo (0.67 +/- 0.85; p < 0.0001). Mean time to ANC recovery was shorter with 
      lipegfilgrastim in each cycle. Treatment-emergent AEs were similar between 
      treatment groups. CONCLUSIONS: Lipegfilgrastim was not statistically superior to 
      placebo for incidence of FN in cycle 1, but was more effective in reducing 
      incidence of severe neutropenia, DSN, and time to ANC recovery, with an 
      acceptable safety profile. Controlled-trials.com identifier: ISRCTN55761467.
FAU - Volovat, Constantin
AU  - Volovat C
AD  - Centrul de Oncologie Medicala, Vasile Conta 2 Str, 700106 Iasi, Romania.
FAU - Bondarenko, Igor M
AU  - Bondarenko IM
AD  - Dnipropetrovsk State Medical Academy, City Clinical Hospital, N 4, 31, Glizhnaya 
      Str, Dnipropetrovsk, 49102 Ukraine.
FAU - Gladkov, Oleg A
AU  - Gladkov OA
AD  - Chelyabinsk Regional Clinical Oncology Dispensary, 42, Blukhera Str., 
      Chelyabinsk, 454087 Russia.
FAU - Elsasser, Reiner
AU  - Elsasser R
AD  - Teva Ratiopharm, Merckle GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany.
FAU - Buchner, Anton
AU  - Buchner A
AD  - Teva Ratiopharm, Merckle GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany.
FAU - Bias, Peter
AU  - Bias P
AD  - Teva Ratiopharm, Merckle GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany.
FAU - Muller, Udo
AU  - Muller U
AD  - Teva Pharmaceuticals, Inc., Graf-Arco-Strasse 3, 89079 Ulm, Germany.
LA  - eng
PT  - Journal Article
DEP - 20150703
PL  - Switzerland
TA  - Springerplus
JT  - SpringerPlus
JID - 101597967
PMC - PMC4489970
OTO - NOTNLM
OT  - Lipegfilgrastim
OT  - Neutropenia
OT  - Non-small cell lung cancer
OT  - Phase III clinical trial
OT  - Recombinant granulocyte colony-stimulating factor
EDAT- 2015/07/15 06:00
MHDA- 2015/07/15 06:01
PMCR- 2015/07/03
CRDT- 2015/07/09 06:00
PHST- 2014/12/18 00:00 [received]
PHST- 2015/05/27 00:00 [accepted]
PHST- 2015/07/09 06:00 [entrez]
PHST- 2015/07/15 06:00 [pubmed]
PHST- 2015/07/15 06:01 [medline]
PHST- 2015/07/03 00:00 [pmc-release]
AID - 1067 [pii]
AID - 10.1186/s40064-015-1067-7 [doi]
PST - epublish
SO  - Springerplus. 2015 Jul 3;4:316. doi: 10.1186/s40064-015-1067-7. eCollection 2015.