7 research outputs found
Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type
BACKGROUND: Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial
evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a
single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving
a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25–120 h after
chemotherapy initiation), compared with a 3-day control regimen (ClinicalTrials.gov, NCT01594749). As the risk for
CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated
the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and
gynecologic cancers).
METHODS: Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy
(HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)–based MEC
on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone
plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The
primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall
and acute phases (0–120 h and 0–24 h after MEC initiation, respectively) were assessed as secondary end points.
Safety and tolerability were also assessed.
RESULTS: CR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/
colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2–22%); similar findings were observed for CR
in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well
tolerated in all cancer subgroups.
CONCLUSIONS: This post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing
CINV in patients receiving MEC, regardless of cancer type.Additional file 1. List of Independent Ethics Committees (IECs).Merck Sharp & Dohme Corphttp://www.biomedcentral.com/bmccancerpm2020Immunolog
A phase III, randomized, double-blind study of single-dose intravenous fosaprepitant in preventing chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy.
Phase III design for a trial of single-dose fosaprepitant (FA) in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).
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International audiencehas a patent T-cell immunotherapy development pending; is a founder and owner of BioCytics, which is a clinical research laboratory developing T-cell immunotherapy; and has previously bought stock in the T-cell companies LionBiotech, Juno, Blue Bird, Kite Pharma, and ZioPharm. CC has received fees during the past 5 years for attending scientific meetings, speaking, organising research, and providing consulting services from AstraZeneca