Comparative clinical trial of granisetron and ondansetron in the prophylaxis of cisplatin-induced emesis

R. Navari, David R Gandara, P. Hesketh, S. Hall, J. Mailliard, H. Ritter, C. Friedman, D. Fitts

Research output: Contribution to journalArticle

141 Citations (Scopus)

Abstract

Purpose: To compare the efficacy and safety of granisetron and ondansetron, serotonin (5-HT3) receptor antagonists shown to be effective in the prevention of chemotherapy-induced emesis. Patients and Methods: In a double-blind, randomized, stratified, parallel-group study, the efficacy and safety of granisetron and ondansetron were compared in 987 chemotherapy- naive patients who received cisplatin in doses ≥ 60 mg/m2. Granisetron was administered as o single dose of 10 or 40 μg/kg before the start of chemotherapy. Ondansetron was administered in doses of 0.15 mg/kg before and 4 and 8 hours after the start of chemotherapy. The three treatment groups were well-matched with respect to demographic characteristics and the dose of cisplatin administered. Results: For all evaluations, single doses of granisetron 10 or 40 μg/kg were as effective as three 0.15-mg/kg doses of ondansetron. Total control (no vomiting, no retching, no nausea, and no use of rescue) was attained by 38%, 41%, and 39% of all patients who received granisetron 10 μg/kg, granisetron 40 μg/kg, and ondansetron, respectively. No vomiting or retching and no use of rescue antiemetics were reported in 47%, 48%, and 51% of patients who received granisetron 10 μg/kg, granisetron 40 μg/kg, and ondansetron, respectively; no nausea and no use of rescue antiemetics were reported in 39%, 42%, and 40% of patients, respectively. Conclusion: All three treatment regimens were well-tolerated. The results of this study indicate that a single dose of granisetron 10 or 40 μg/kg is as effective as three doses of ondansetron 0.15 mg/kg in the prevention of nausea and vomiting induced by cisplatin chemotherapy.

Original languageEnglish (US)
Pages (from-to)1242-1248
Number of pages7
JournalJournal of Clinical Oncology
Volume13
Issue number5
StatePublished - May 1995
Externally publishedYes

Fingerprint

Granisetron
Ondansetron
Cisplatin
Vomiting
Clinical Trials
Drug Therapy
Nausea
Antiemetics
Serotonin 5-HT3 Receptor Antagonists
Safety
Demography

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Navari, R., Gandara, D. R., Hesketh, P., Hall, S., Mailliard, J., Ritter, H., ... Fitts, D. (1995). Comparative clinical trial of granisetron and ondansetron in the prophylaxis of cisplatin-induced emesis. Journal of Clinical Oncology, 13(5), 1242-1248.

Comparative clinical trial of granisetron and ondansetron in the prophylaxis of cisplatin-induced emesis. / Navari, R.; Gandara, David R; Hesketh, P.; Hall, S.; Mailliard, J.; Ritter, H.; Friedman, C.; Fitts, D.

In: Journal of Clinical Oncology, Vol. 13, No. 5, 05.1995, p. 1242-1248.

Research output: Contribution to journalArticle

Navari, R, Gandara, DR, Hesketh, P, Hall, S, Mailliard, J, Ritter, H, Friedman, C & Fitts, D 1995, 'Comparative clinical trial of granisetron and ondansetron in the prophylaxis of cisplatin-induced emesis', Journal of Clinical Oncology, vol. 13, no. 5, pp. 1242-1248.
Navari, R. ; Gandara, David R ; Hesketh, P. ; Hall, S. ; Mailliard, J. ; Ritter, H. ; Friedman, C. ; Fitts, D. / Comparative clinical trial of granisetron and ondansetron in the prophylaxis of cisplatin-induced emesis. In: Journal of Clinical Oncology. 1995 ; Vol. 13, No. 5. pp. 1242-1248.
@article{ada045e9c38a46ecb572012e29fd4e14,
title = "Comparative clinical trial of granisetron and ondansetron in the prophylaxis of cisplatin-induced emesis",
abstract = "Purpose: To compare the efficacy and safety of granisetron and ondansetron, serotonin (5-HT3) receptor antagonists shown to be effective in the prevention of chemotherapy-induced emesis. Patients and Methods: In a double-blind, randomized, stratified, parallel-group study, the efficacy and safety of granisetron and ondansetron were compared in 987 chemotherapy- naive patients who received cisplatin in doses ≥ 60 mg/m2. Granisetron was administered as o single dose of 10 or 40 μg/kg before the start of chemotherapy. Ondansetron was administered in doses of 0.15 mg/kg before and 4 and 8 hours after the start of chemotherapy. The three treatment groups were well-matched with respect to demographic characteristics and the dose of cisplatin administered. Results: For all evaluations, single doses of granisetron 10 or 40 μg/kg were as effective as three 0.15-mg/kg doses of ondansetron. Total control (no vomiting, no retching, no nausea, and no use of rescue) was attained by 38{\%}, 41{\%}, and 39{\%} of all patients who received granisetron 10 μg/kg, granisetron 40 μg/kg, and ondansetron, respectively. No vomiting or retching and no use of rescue antiemetics were reported in 47{\%}, 48{\%}, and 51{\%} of patients who received granisetron 10 μg/kg, granisetron 40 μg/kg, and ondansetron, respectively; no nausea and no use of rescue antiemetics were reported in 39{\%}, 42{\%}, and 40{\%} of patients, respectively. Conclusion: All three treatment regimens were well-tolerated. The results of this study indicate that a single dose of granisetron 10 or 40 μg/kg is as effective as three doses of ondansetron 0.15 mg/kg in the prevention of nausea and vomiting induced by cisplatin chemotherapy.",
author = "R. Navari and Gandara, {David R} and P. Hesketh and S. Hall and J. Mailliard and H. Ritter and C. Friedman and D. Fitts",
year = "1995",
month = "5",
language = "English (US)",
volume = "13",
pages = "1242--1248",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "5",

}

TY - JOUR

T1 - Comparative clinical trial of granisetron and ondansetron in the prophylaxis of cisplatin-induced emesis

AU - Navari, R.

AU - Gandara, David R

AU - Hesketh, P.

AU - Hall, S.

AU - Mailliard, J.

AU - Ritter, H.

AU - Friedman, C.

AU - Fitts, D.

PY - 1995/5

Y1 - 1995/5

N2 - Purpose: To compare the efficacy and safety of granisetron and ondansetron, serotonin (5-HT3) receptor antagonists shown to be effective in the prevention of chemotherapy-induced emesis. Patients and Methods: In a double-blind, randomized, stratified, parallel-group study, the efficacy and safety of granisetron and ondansetron were compared in 987 chemotherapy- naive patients who received cisplatin in doses ≥ 60 mg/m2. Granisetron was administered as o single dose of 10 or 40 μg/kg before the start of chemotherapy. Ondansetron was administered in doses of 0.15 mg/kg before and 4 and 8 hours after the start of chemotherapy. The three treatment groups were well-matched with respect to demographic characteristics and the dose of cisplatin administered. Results: For all evaluations, single doses of granisetron 10 or 40 μg/kg were as effective as three 0.15-mg/kg doses of ondansetron. Total control (no vomiting, no retching, no nausea, and no use of rescue) was attained by 38%, 41%, and 39% of all patients who received granisetron 10 μg/kg, granisetron 40 μg/kg, and ondansetron, respectively. No vomiting or retching and no use of rescue antiemetics were reported in 47%, 48%, and 51% of patients who received granisetron 10 μg/kg, granisetron 40 μg/kg, and ondansetron, respectively; no nausea and no use of rescue antiemetics were reported in 39%, 42%, and 40% of patients, respectively. Conclusion: All three treatment regimens were well-tolerated. The results of this study indicate that a single dose of granisetron 10 or 40 μg/kg is as effective as three doses of ondansetron 0.15 mg/kg in the prevention of nausea and vomiting induced by cisplatin chemotherapy.

AB - Purpose: To compare the efficacy and safety of granisetron and ondansetron, serotonin (5-HT3) receptor antagonists shown to be effective in the prevention of chemotherapy-induced emesis. Patients and Methods: In a double-blind, randomized, stratified, parallel-group study, the efficacy and safety of granisetron and ondansetron were compared in 987 chemotherapy- naive patients who received cisplatin in doses ≥ 60 mg/m2. Granisetron was administered as o single dose of 10 or 40 μg/kg before the start of chemotherapy. Ondansetron was administered in doses of 0.15 mg/kg before and 4 and 8 hours after the start of chemotherapy. The three treatment groups were well-matched with respect to demographic characteristics and the dose of cisplatin administered. Results: For all evaluations, single doses of granisetron 10 or 40 μg/kg were as effective as three 0.15-mg/kg doses of ondansetron. Total control (no vomiting, no retching, no nausea, and no use of rescue) was attained by 38%, 41%, and 39% of all patients who received granisetron 10 μg/kg, granisetron 40 μg/kg, and ondansetron, respectively. No vomiting or retching and no use of rescue antiemetics were reported in 47%, 48%, and 51% of patients who received granisetron 10 μg/kg, granisetron 40 μg/kg, and ondansetron, respectively; no nausea and no use of rescue antiemetics were reported in 39%, 42%, and 40% of patients, respectively. Conclusion: All three treatment regimens were well-tolerated. The results of this study indicate that a single dose of granisetron 10 or 40 μg/kg is as effective as three doses of ondansetron 0.15 mg/kg in the prevention of nausea and vomiting induced by cisplatin chemotherapy.

UR - http://www.scopus.com/inward/record.url?scp=0029033527&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0029033527&partnerID=8YFLogxK

M3 - Article

C2 - 7738628

AN - SCOPUS:0029033527

VL - 13

SP - 1242

EP - 1248

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 5

ER -