A randomized, placebo-controlled pilot trial of aprepitant combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients undergoing cyclophosphamide-based conditioning regimens prior to hematopoietic stem cell transplant (HSCT)

Joseph Bubalo, Kelsey Mulverhill, Gabrielle Meyers, Brandon Hayes-Lattin, Richard Maziarz

Research output: Contribution to journalArticle

Abstract

The aim of this study was to evaluate the safety and efficacy of aprepitant when used prophylactically to prevent nausea and vomiting during cyclophosphamide-based conditioning regimens. The primary objective of this study was to determine if there was a difference in the number of emesis-free days in patients who received aprepitant as compared to those who received placebo. This prospective, randomized, double blind, placebo-controlled study was performed in 40 adult patients who received a cyclophosphamide-containing HSCT conditioning regimen. Twenty patients were randomized to receive aprepitant, ondansetron, and dexamethasone, and 20 were randomized to receive placebo, ondansetron, and dexamethasone. Complete response (CR) was defined as the absence of emesis and the absence of mild to moderate nausea. The average number of emesis-free days was 14.25 (standard deviation 1.48 days) in the aprepitant group compared to 12.45 days (standard deviation 2.16 days) for patients in the placebo group. Eight patients (40%) in the aprepitant group achieved CR as compared to four patients (20%) in the placebo group. In the setting of cyclophosphamide-containing conditioning regimens, the addition of aprepitant to a standard antiemetic regimen decreased the incidence of emesis as compared to placebo. Aprepitant was well tolerated.

Original languageEnglish (US)
Pages (from-to)1-9
Number of pages9
JournalBone Marrow Transplantation
DOIs
StateAccepted/In press - Feb 20 2018

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aprepitant
Antiemetics
Hematopoietic Stem Cells
Cyclophosphamide
Nausea
Vomiting
Placebos
Transplants
Drug Therapy
Ondansetron
Dexamethasone
Therapeutics

ASJC Scopus subject areas

  • Hematology
  • Transplantation

Cite this

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title = "A randomized, placebo-controlled pilot trial of aprepitant combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients undergoing cyclophosphamide-based conditioning regimens prior to hematopoietic stem cell transplant (HSCT)",
abstract = "The aim of this study was to evaluate the safety and efficacy of aprepitant when used prophylactically to prevent nausea and vomiting during cyclophosphamide-based conditioning regimens. The primary objective of this study was to determine if there was a difference in the number of emesis-free days in patients who received aprepitant as compared to those who received placebo. This prospective, randomized, double blind, placebo-controlled study was performed in 40 adult patients who received a cyclophosphamide-containing HSCT conditioning regimen. Twenty patients were randomized to receive aprepitant, ondansetron, and dexamethasone, and 20 were randomized to receive placebo, ondansetron, and dexamethasone. Complete response (CR) was defined as the absence of emesis and the absence of mild to moderate nausea. The average number of emesis-free days was 14.25 (standard deviation 1.48 days) in the aprepitant group compared to 12.45 days (standard deviation 2.16 days) for patients in the placebo group. Eight patients (40{\%}) in the aprepitant group achieved CR as compared to four patients (20{\%}) in the placebo group. In the setting of cyclophosphamide-containing conditioning regimens, the addition of aprepitant to a standard antiemetic regimen decreased the incidence of emesis as compared to placebo. Aprepitant was well tolerated.",
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AU - Hayes-Lattin, Brandon

AU - Maziarz, Richard

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