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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 Herrington JD; Jaskiewicz AD; Song JCancer 2008[May]; 112 (9): 2080-7BACKGROUND: 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.|Acute Disease[MESH]|Antiemetics/*administration & dosage[MESH]|Antineoplastic Agents/*adverse effects[MESH]|Aprepitant[MESH]|Dexamethasone/*administration & dosage[MESH]|Double-Blind Method[MESH]|Drug Therapy, Combination[MESH]|Humans[MESH]|Isoquinolines/*administration & dosage[MESH]|Morpholines/*administration & dosage[MESH]|Nausea/*prevention & control[MESH]|Palonosetron[MESH]|Pilot Projects[MESH]|Quinuclidines/*administration & dosage[MESH]|Vomiting/*prevention & control[MESH] |
