Phase III, randomized, double-blind, placebo-controlled, multicenter study of lipegfilgrastim in XXXX with @entity1149 receiving myelosuppressive therapy.

@entity1 @entity1149 @entity900 @entity2879 @entity1398
PURPOSE: The aim of this study was to demonstrate lipegfilgrastim superiority versus placebo in adults with @entity1149 receiving myelosuppressive chemotherapy. METHODS: This phase III, double-blind study randomized chemotherapy-naive @entity1 to receive @entity900 and @entity2879 with either lipegfilgrastim 6  mg or placebo. Because of the placebo control, @entity1 at individual high risk for @entity1398 ( @entity1398 ; >= 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 @entity1398 incidence in cycle 1. Secondary assessments included @entity1398 ( @entity1398 ), absolute neutrophil count (ANC) profile, and adverse events (AEs). RESULTS: The study included 375 @entity1 (lipegfilgrastim, n  =  250; placebo, n  =  125). Lipegfilgrastim superiority for @entity1398 incidence in cycle 1 was not achieved but incidence was lower (2.4%) versus placebo (5.6%). Cycle 1 mean @entity1398 was significantly shorter for lipegfilgrastim (0.6      1.1  days) versus placebo (2.3      0.5  days; p  <  0.0001). Incidence of severe @entity1398 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 @entity1398 in cycle 1, but was more effective in reducing incidence of severe @entity1398 , @entity1398 , and time to ANC recovery, with an acceptable safety profile. Controlled-trials.com identifier: ISRCTN55761467.
