Efficacy and safety of different doses of granisetron for the prophylaxis of cisplatin-induced emesis

Edith A. Perez, Rudolph M. Navari, Henry G. Kaplan, Richard J. Gralla, Steven M. Grunberg, Robert H. Palmer, David Fitts

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Abstract

The purpose of this study was to evaluate the efficacy and safety of four different doses of granisetron when administered as a single intravenous (i.v.) dose for prophylaxis of cisplatin-induced emesis in a multicenter, randomized, parallel-group, double-blind investigation. A total of 353 chemotherapy-naive patients were enrolled, stratified according to cisplatin dose (moderate dose: 50-80 mg/m2, n = 169; high dose: 81120 mg/m2, n = 184) and randomized to one of four granisetron doses: 5, 10, 20, or 40 μg/kg. Control of emesis was evaluated by the percentages of patients attaining complete response (no vomiting or retching, and no rescue medication) and major response (≤2 episodes of vomiting or retching, and no rescue medication). Patients were assessed on an inpatient basis for 18-24 h. Safety analyses consisted of adverse events and laboratory parameter changes. Complete response rates over 24 h after chemotherapy were 23%, 48%, 48%, and 44% for granisetron doses of 5, 10, 20, and 40 μg/kg, respectively, in the combined patient population (P=0.011 for linear trend); 29%, 56%, 58%, and 41%, respectively, in the moderate-dose cisplatin stratum (P=0.278 for linear trend); and 18%, 41%, 40%, and 47%, respectively, in the high-dose cisplatin stratum (P=0.011 for linear trend). Transient headache was the most frequently reported adverse event (19%). There was no evidence of association between increased dose and headache. A single 10-, 20- or 40-μg/kg dose of granisetron is comparably effective in controlling nausea and vomiting associated with moderate-or high-dose cisplatin chemotherapy. Granisetron was safe and well tolerated at all doses.

Original languageEnglish (US)
Pages (from-to)31-37
Number of pages7
JournalSupportive Care in Cancer
Volume5
Issue number1
DOIs
StatePublished - Jan 1997

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Granisetron
Cisplatin
Vomiting
Safety
Drug Therapy
Headache
Nausea
Inpatients
Population

Keywords

  • Antiemetic therapy
  • Cancer chemotherapy
  • Cisplatin
  • Emesis
  • Granisetron

ASJC Scopus subject areas

  • Oncology
  • Nursing(all)

Cite this

Perez, E. A., Navari, R. M., Kaplan, H. G., Gralla, R. J., Grunberg, S. M., Palmer, R. H., & Fitts, D. (1997). Efficacy and safety of different doses of granisetron for the prophylaxis of cisplatin-induced emesis. Supportive Care in Cancer, 5(1), 31-37. https://doi.org/10.1007/s005200050037

Efficacy and safety of different doses of granisetron for the prophylaxis of cisplatin-induced emesis. / Perez, Edith A.; Navari, Rudolph M.; Kaplan, Henry G.; Gralla, Richard J.; Grunberg, Steven M.; Palmer, Robert H.; Fitts, David.

In: Supportive Care in Cancer, Vol. 5, No. 1, 01.1997, p. 31-37.

Research output: Contribution to journalArticle

Perez, EA, Navari, RM, Kaplan, HG, Gralla, RJ, Grunberg, SM, Palmer, RH & Fitts, D 1997, 'Efficacy and safety of different doses of granisetron for the prophylaxis of cisplatin-induced emesis', Supportive Care in Cancer, vol. 5, no. 1, pp. 31-37. https://doi.org/10.1007/s005200050037
Perez, Edith A. ; Navari, Rudolph M. ; Kaplan, Henry G. ; Gralla, Richard J. ; Grunberg, Steven M. ; Palmer, Robert H. ; Fitts, David. / Efficacy and safety of different doses of granisetron for the prophylaxis of cisplatin-induced emesis. In: Supportive Care in Cancer. 1997 ; Vol. 5, No. 1. pp. 31-37.
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