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.
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.
Herrington
Jon D
JD
Department of Pharmacy, Scott & White Memorial Hospital, Texas A&M University Health Care System, Temple, TX 76508, USA. jherrington@swmail.sw.org
Jaskiewicz
Adam D
AD
Song
Juhee
J
D000208:Acute Disease; D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000077608:Aprepitant; D003907:Dexamethasone / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage*; D009025:Morpholines / Q000008:administration & dosage*; D009325:Nausea / Q000517:prevention & control*; D000077924:Palonosetron; D010865:Pilot Projects; D011812:Quinuclidines / Q000008:administration & dosage*; D014839:Vomiting / Q000517:prevention & control*
D000932:Antiemetics; D000970:Antineoplastic Agents; D007546:Isoquinolines; D009025:Morpholines; D011812:Quinuclidines; D000077608:Aprepitant; D000077924:Palonosetron; D003907:Dexamethasone