A Randomized Double-Blinded Comparison of the Antiemetic Efficacy of Ondansetron and Droperidol in Patients Receiving High-Dose Interleukin-2

Hyun Kim, Steven A. Rosenberg, Seth M. Steinberg, David J. Cole, Jeffrey S. Weber

Research output: Contribution to journalArticle

Abstract

Emesis and nausea are common toxicities seen during high-dose interleukin-2 (IL-2) therapy (720,000 IU/kg i.v. every 8 h). A growing list of randomized studies have documented the efficacy of ondansetron, a potent antagonist of the 5-hydroxytryptamine3receptor, in preventing acute chemotherapy-induced emesis and nausea. However, no study has evaluated the efficacy of ondansetron in preventing IL-2-induced emesis and nausea. This double-blinded, randomized trial was performed to compare the antiemetic and antinausea efficacy of ondansetron with that of droperidol, a butyrophenone, in patients receiving high-dose IL-2 on protocols at the National Cancer Institute. Ondansetron or droperidol was given intravenously, 30 min prior to the first dose of IL-2 and then every 8 h for the duration of IL-2 treatment. No significant differences were seen between the two agents in complete freedom from emesis (p2 = 0.51), level of nausea (p2 = 0.17), antiemetic treatment failure (p2 = 0.89), and time to first emetic episode (p2 = 0.44). Equivalent doses of IL-2 were administered on each arm of the study, with a similar incidence of liver dysfunction (p2 = 0.15) and diarrhea (p2 = 0.64). Finally, there was no significant difference in the response rates to metastatic disease in either arm of the antiemetic study (p2 = 0.67), and these response rates were similar to those in other patients treated under immunotherapy protocols in the Surgery Branch of the National Cancer Institute with high-dose IL-2. We conclude that droperidol is equally effective in preventing emesis and controlling nausea when compared with ondansetron for patients receiving high-dose IL-2.

Original languageEnglish (US)
Pages (from-to)60-65
Number of pages6
JournalJournal of Immunotherapy
Volume16
Issue number1
StatePublished - 1994
Externally publishedYes

Fingerprint

Droperidol
Ondansetron
Antiemetics
Interleukin-2
Nausea
Vomiting
National Cancer Institute (U.S.)
Butyrophenones
Emetics
Treatment Failure
Immunotherapy
Liver Diseases
Diarrhea
Drug Therapy
Incidence

Keywords

  • Antiemesis
  • Antinausea
  • Droperidol
  • High-dose interleukin-2
  • Ondansetron

ASJC Scopus subject areas

  • Cancer Research
  • Immunology
  • Immunology and Allergy
  • Pharmacology

Cite this

A Randomized Double-Blinded Comparison of the Antiemetic Efficacy of Ondansetron and Droperidol in Patients Receiving High-Dose Interleukin-2. / Kim, Hyun; Rosenberg, Steven A.; Steinberg, Seth M.; Cole, David J.; Weber, Jeffrey S.

In: Journal of Immunotherapy, Vol. 16, No. 1, 1994, p. 60-65.

Research output: Contribution to journalArticle

Kim, Hyun ; Rosenberg, Steven A. ; Steinberg, Seth M. ; Cole, David J. ; Weber, Jeffrey S. / A Randomized Double-Blinded Comparison of the Antiemetic Efficacy of Ondansetron and Droperidol in Patients Receiving High-Dose Interleukin-2. In: Journal of Immunotherapy. 1994 ; Vol. 16, No. 1. pp. 60-65.
@article{2781fd89f1c44a6d81a1f00519e54c5f,
title = "A Randomized Double-Blinded Comparison of the Antiemetic Efficacy of Ondansetron and Droperidol in Patients Receiving High-Dose Interleukin-2",
abstract = "Emesis and nausea are common toxicities seen during high-dose interleukin-2 (IL-2) therapy (720,000 IU/kg i.v. every 8 h). A growing list of randomized studies have documented the efficacy of ondansetron, a potent antagonist of the 5-hydroxytryptamine3receptor, in preventing acute chemotherapy-induced emesis and nausea. However, no study has evaluated the efficacy of ondansetron in preventing IL-2-induced emesis and nausea. This double-blinded, randomized trial was performed to compare the antiemetic and antinausea efficacy of ondansetron with that of droperidol, a butyrophenone, in patients receiving high-dose IL-2 on protocols at the National Cancer Institute. Ondansetron or droperidol was given intravenously, 30 min prior to the first dose of IL-2 and then every 8 h for the duration of IL-2 treatment. No significant differences were seen between the two agents in complete freedom from emesis (p2 = 0.51), level of nausea (p2 = 0.17), antiemetic treatment failure (p2 = 0.89), and time to first emetic episode (p2 = 0.44). Equivalent doses of IL-2 were administered on each arm of the study, with a similar incidence of liver dysfunction (p2 = 0.15) and diarrhea (p2 = 0.64). Finally, there was no significant difference in the response rates to metastatic disease in either arm of the antiemetic study (p2 = 0.67), and these response rates were similar to those in other patients treated under immunotherapy protocols in the Surgery Branch of the National Cancer Institute with high-dose IL-2. We conclude that droperidol is equally effective in preventing emesis and controlling nausea when compared with ondansetron for patients receiving high-dose IL-2.",
keywords = "Antiemesis, Antinausea, Droperidol, High-dose interleukin-2, Ondansetron",
author = "Hyun Kim and Rosenberg, {Steven A.} and Steinberg, {Seth M.} and Cole, {David J.} and Weber, {Jeffrey S.}",
year = "1994",
language = "English (US)",
volume = "16",
pages = "60--65",
journal = "Journal of Immunotherapy",
issn = "1524-9557",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

TY - JOUR

T1 - A Randomized Double-Blinded Comparison of the Antiemetic Efficacy of Ondansetron and Droperidol in Patients Receiving High-Dose Interleukin-2

AU - Kim, Hyun

AU - Rosenberg, Steven A.

AU - Steinberg, Seth M.

AU - Cole, David J.

AU - Weber, Jeffrey S.

PY - 1994

Y1 - 1994

N2 - Emesis and nausea are common toxicities seen during high-dose interleukin-2 (IL-2) therapy (720,000 IU/kg i.v. every 8 h). A growing list of randomized studies have documented the efficacy of ondansetron, a potent antagonist of the 5-hydroxytryptamine3receptor, in preventing acute chemotherapy-induced emesis and nausea. However, no study has evaluated the efficacy of ondansetron in preventing IL-2-induced emesis and nausea. This double-blinded, randomized trial was performed to compare the antiemetic and antinausea efficacy of ondansetron with that of droperidol, a butyrophenone, in patients receiving high-dose IL-2 on protocols at the National Cancer Institute. Ondansetron or droperidol was given intravenously, 30 min prior to the first dose of IL-2 and then every 8 h for the duration of IL-2 treatment. No significant differences were seen between the two agents in complete freedom from emesis (p2 = 0.51), level of nausea (p2 = 0.17), antiemetic treatment failure (p2 = 0.89), and time to first emetic episode (p2 = 0.44). Equivalent doses of IL-2 were administered on each arm of the study, with a similar incidence of liver dysfunction (p2 = 0.15) and diarrhea (p2 = 0.64). Finally, there was no significant difference in the response rates to metastatic disease in either arm of the antiemetic study (p2 = 0.67), and these response rates were similar to those in other patients treated under immunotherapy protocols in the Surgery Branch of the National Cancer Institute with high-dose IL-2. We conclude that droperidol is equally effective in preventing emesis and controlling nausea when compared with ondansetron for patients receiving high-dose IL-2.

AB - Emesis and nausea are common toxicities seen during high-dose interleukin-2 (IL-2) therapy (720,000 IU/kg i.v. every 8 h). A growing list of randomized studies have documented the efficacy of ondansetron, a potent antagonist of the 5-hydroxytryptamine3receptor, in preventing acute chemotherapy-induced emesis and nausea. However, no study has evaluated the efficacy of ondansetron in preventing IL-2-induced emesis and nausea. This double-blinded, randomized trial was performed to compare the antiemetic and antinausea efficacy of ondansetron with that of droperidol, a butyrophenone, in patients receiving high-dose IL-2 on protocols at the National Cancer Institute. Ondansetron or droperidol was given intravenously, 30 min prior to the first dose of IL-2 and then every 8 h for the duration of IL-2 treatment. No significant differences were seen between the two agents in complete freedom from emesis (p2 = 0.51), level of nausea (p2 = 0.17), antiemetic treatment failure (p2 = 0.89), and time to first emetic episode (p2 = 0.44). Equivalent doses of IL-2 were administered on each arm of the study, with a similar incidence of liver dysfunction (p2 = 0.15) and diarrhea (p2 = 0.64). Finally, there was no significant difference in the response rates to metastatic disease in either arm of the antiemetic study (p2 = 0.67), and these response rates were similar to those in other patients treated under immunotherapy protocols in the Surgery Branch of the National Cancer Institute with high-dose IL-2. We conclude that droperidol is equally effective in preventing emesis and controlling nausea when compared with ondansetron for patients receiving high-dose IL-2.

KW - Antiemesis

KW - Antinausea

KW - Droperidol

KW - High-dose interleukin-2

KW - Ondansetron

UR - http://www.scopus.com/inward/record.url?scp=0028235591&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0028235591&partnerID=8YFLogxK

M3 - Article

C2 - 8081560

AN - SCOPUS:0028235591

VL - 16

SP - 60

EP - 65

JO - Journal of Immunotherapy

JF - Journal of Immunotherapy

SN - 1524-9557

IS - 1

ER -