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-hydroxytryptamine3 receptor, 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.
authors.affiliation: Surgery Branch, National Cancer Institute, Bethesda, Maryland.
authors.forename: H
authors.initials: H
authors.lastname: Kim
authors.forename: S A
authors.initials: SA
authors.lastname: Rosenberg
authors.forename: S M
authors.initials: SM
authors.lastname: Steinberg
authors.forename: D J
authors.initials: DJ
authors.lastname: Cole
authors.forename: J S
authors.initials: JS
authors.lastname: Weber
mesh_terms: D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000150:complications / Q000628:therapy; D004329:Droperidol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000009:adverse effects* / Q000627:therapeutic use; D008228:Lymphoma, Non-Hodgkin / Q000150:complications / Q000628:therapy; D008297:Male; D008545:Melanoma / Q000150:complications / Q000628:therapy; D008875:Middle Aged; D009325:Nausea / Q000517:prevention & control*; D009362:Neoplasm Metastasis; D017294:Ondansetron / Q000627:therapeutic use*
chemical_list: D007376:Interleukin-2; D017294:Ondansetron; D004329:Droperidol