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2015 ; 4
(ä): 316
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English Wikipedia
Phase III, randomized, double-blind, placebo-controlled, multicenter study of
lipegfilgrastim in patients with non-small cell lung cancer receiving
myelosuppressive therapy
#MMPMID26155455
Volovat C
; Bondarenko IM
; Gladkov OA
; Elsässer R
; Buchner A
; Bias P
; Müller U
Springerplus
2015[]; 4
(ä): 316
PMID26155455
show ga
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.