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Randomized, placebo‐controlled, pilot study evaluating aprepitant single dose plus palonosetron and dexamethasone for the prevention of acute and delayed chemotherapy‐induced nausea and vomiting
Author(s) -
Herrington Jon D.,
Jaskiewicz Adam D.,
Song Juhee
Publication year - 2008
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.23364
Subject(s) - aprepitant , palonosetron , medicine , nausea , vomiting , placebo , chemotherapy induced nausea and vomiting , anesthesia , antiemetic , clinical endpoint , chemotherapy , dexamethasone , ondansetron , randomized controlled trial , alternative medicine , pathology
BACKGROUND. The combination of palonosetron and aprepitant is safe and effective in the prevention of chemotherapy‐induced emesis (CIE). The purpose of this pilot study was to ascertain the effectiveness of 1‐day versus 3‐day aprepitant in the prevention of acute and delayed nausea and vomiting in patients who were receiving highly emetogenic chemotherapy. METHODS. This study was institutional review board‐approved and informed consent was obtained before this study was begun. This was a pilot, single‐institution, randomized, double‐blind, placebo‐controlled trial that evaluated 3 different treatment arms. All groups received palonosetron 0.25 mg intravenously on Day 1 and dexamethasone on Days 1–4. Arm A received aprepitant 125 mg orally on Day 1 followed by 80 mg on Days 2–3. Arm B received aprepitant 125 mg orally on Day 1 and placebo on Days 2–3. Arm C received placebos on Days 1–3. The primary endpoint was to evaluate the proportion of patients with acute and delayed emesis within each group. RESULTS. Seventy‐five patients were included in the analysis. The study commenced with 3 groups; however, an interim analysis displayed unacceptable emesis events in Arm C, and this group was terminated. There were no significant differences between Arms A and B for emesis, nausea, or the use of breakthrough antiemetics. In Arms A and B, 93% of patients were emesis‐free from Days 1–5 compared with only 50% in Arm C. CONCLUSIONS. From this pilot study of patients who were receiving palonosetron, aprepitant, and dexamethasone for highly emetogenic chemotherapy, a single dose of aprepitant displayed similar effectiveness compared with 3‐day aprepitant. Cancer 2008. © 2008 American Cancer Society.