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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Ann+Oncol
2014 ; 25
(7
): 1333-1339
Nephropedia Template TP
gab.com Text
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English Wikipedia
A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose
combination of netupitant and palonosetron, for prevention of
chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy
#MMPMID24631949
Gralla RJ
; Bosnjak SM
; Hontsa A
; Balser C
; Rizzi G
; Rossi G
; Borroni ME
; Jordan K
Ann Oncol
2014[Jul]; 25
(7
): 1333-1339
PMID24631949
show ga
BACKGROUND: Safe, effective and convenient antiemetic regimens that preserve
benefit over repeated cycles are needed for optimal supportive care during cancer
treatment. NEPA, an oral fixed-dose combination of netupitant, a highly selective
NK1 receptor antagonist (RA), and palonosetron (PALO), a distinct 5-HT3 RA, was
shown to be superior to PALO in preventing chemotherapy-induced nausea and
vomiting after a single cycle of highly (HEC) or moderately (MEC) emetogenic
chemotherapy in recent trials. This study was designed primarily to assess the
safety but also to evaluate the efficacy of NEPA over multiple cycles of HEC and
MEC. PATIENTS AND METHODS: This multinational, double-blind, randomized phase III
study (NCT01376297) in 413 chemotherapy-naïve patients evaluated a single oral
dose of NEPA (NETU 300 mg + PALO 0.50 mg) given on day 1 with oral dexamethasone
(DEX). An oral 3-day aprepitant (APR) regimen + PALO + DEX was included as a
control (3:1 NEPA:APR randomization). In HEC, DEX was administered on days 1-4
and in MEC on day 1. Safety was assessed primarily by adverse events (AEs),
including cardiac AEs; efficacy by complete response (CR: no emesis, no rescue).
RESULTS: Patients completed 1961 total chemotherapy cycles (76% MEC, 24% HEC)
with 75% completing ?4 cycles. The incidence/type of AEs was comparable for both
groups. Most frequent NEPA-related AEs included constipation (3.6%) and headache
(1.0%); there was no indication of increasing AEs over multiple cycles. The
majority of AEs were mild/moderate and there were no cardiac safety concerns
based on AEs and electrocardiograms. The overall (0-120 h) CR rates in cycle 1
were 81% and 76% for NEPA and APR + PALO, respectively, and antiemetic efficacy
was maintained over repeated cycles. CONCLUSIONS: NEPA, a convenient single oral
dose antiemetic targeting dual pathways, was safe, well tolerated and highly
effective over multiple cycles of HEC/MEC.