Efficacy and safety of granisetron, a selective 5-hydroxytryptamine-3 receptor antagonist, in the prevention of nausea and vomiting induced by high-dose cisplatin

R. M. Navari, H. G. Kaplan, Richard J. Gralla, S. M. Grunberg, R. Palmer, D. Fitts

Research output: Contribution to journalArticle

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Abstract

Purpose: To assess the antiemetic effects and safety profile of four different doses of granisetron (Kytril; SmithKline Beecham Pharmaceuticals, Philadelphia, PA) when administered as a single intravenous (IV) dose for prophylaxis of cisplatin-induced nausea and vomiting. Patients and Methods: One hundred eighty-four chemotherapy-naive patients receiving high-dose cisplatin (81 to 120 mg/m2) were randomized to receive one of four granisetron doses (5, 10, 20, or 40 μg/kg) administered before chemotherapy. Patients were observed on an inpatient basis for 18 to 24 hours, and vital signs, nausea, vomiting, retching, and appetite were assessed. Safety analyses included incidence of adverse experiences and laboratory parameter changes. Results: After granisetron doses of 5, 10, 20, and 40 μg/kg, a major response (≤ two vomiting or retching episodes, and no antiemetic rescue) was recorded in 23%, 57%, 58%, and 60% of patients, respectively, and a complete response (no vomiting or retching, and no antiemetic rescue) in 18%, 41%, 40%, and 47% of patients, respectively. There was a statistically longer time to first episode of nausea (P = .0015) and vomiting (P = .0001), and fewer patients were administered additional antiemetic medication in the 10-μg/kg dosing groups than in the 5-μg/kg dosing group. As granisetron dose increased, appetite return increased (P = .040). Headache was the most frequently reported adverse event (20%). Conclusion: A single 10-, 20-, or 40-μg/kg dose of granisetron was effective in controlling vomiting in 57% to 60% of patients who received cisplatin at doses greater than 81 mg/m2 and totally prevented vomiting in 40% to 47% of patients. There were no statistically significant differences in efficacy between the 10-μg/kg dose and the 20- and 40-μg/kg doses. Granisetron was well tolerated at all doses.

Original languageEnglish (US)
Pages (from-to)2204-2210
Number of pages7
JournalJournal of Clinical Oncology
Volume12
Issue number10
StatePublished - Oct 1994
Externally publishedYes

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Granisetron
Receptors, Serotonin, 5-HT3
Nausea
Cisplatin
Vomiting
Safety
Antiemetics
Appetite
Drug Therapy
Vital Signs
Headache
Inpatients

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Efficacy and safety of granisetron, a selective 5-hydroxytryptamine-3 receptor antagonist, in the prevention of nausea and vomiting induced by high-dose cisplatin. / Navari, R. M.; Kaplan, H. G.; Gralla, Richard J.; Grunberg, S. M.; Palmer, R.; Fitts, D.

In: Journal of Clinical Oncology, Vol. 12, No. 10, 10.1994, p. 2204-2210.

Research output: Contribution to journalArticle

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abstract = "Purpose: To assess the antiemetic effects and safety profile of four different doses of granisetron (Kytril; SmithKline Beecham Pharmaceuticals, Philadelphia, PA) when administered as a single intravenous (IV) dose for prophylaxis of cisplatin-induced nausea and vomiting. Patients and Methods: One hundred eighty-four chemotherapy-naive patients receiving high-dose cisplatin (81 to 120 mg/m2) were randomized to receive one of four granisetron doses (5, 10, 20, or 40 μg/kg) administered before chemotherapy. Patients were observed on an inpatient basis for 18 to 24 hours, and vital signs, nausea, vomiting, retching, and appetite were assessed. Safety analyses included incidence of adverse experiences and laboratory parameter changes. Results: After granisetron doses of 5, 10, 20, and 40 μg/kg, a major response (≤ two vomiting or retching episodes, and no antiemetic rescue) was recorded in 23{\%}, 57{\%}, 58{\%}, and 60{\%} of patients, respectively, and a complete response (no vomiting or retching, and no antiemetic rescue) in 18{\%}, 41{\%}, 40{\%}, and 47{\%} of patients, respectively. There was a statistically longer time to first episode of nausea (P = .0015) and vomiting (P = .0001), and fewer patients were administered additional antiemetic medication in the 10-μg/kg dosing groups than in the 5-μg/kg dosing group. As granisetron dose increased, appetite return increased (P = .040). Headache was the most frequently reported adverse event (20{\%}). Conclusion: A single 10-, 20-, or 40-μg/kg dose of granisetron was effective in controlling vomiting in 57{\%} to 60{\%} of patients who received cisplatin at doses greater than 81 mg/m2 and totally prevented vomiting in 40{\%} to 47{\%} of patients. There were no statistically significant differences in efficacy between the 10-μg/kg dose and the 20- and 40-μg/kg doses. Granisetron was well tolerated at all doses.",
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T1 - Efficacy and safety of granisetron, a selective 5-hydroxytryptamine-3 receptor antagonist, in the prevention of nausea and vomiting induced by high-dose cisplatin

AU - Navari, R. M.

AU - Kaplan, H. G.

AU - Gralla, Richard J.

AU - Grunberg, S. M.

AU - Palmer, R.

AU - Fitts, D.

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N2 - Purpose: To assess the antiemetic effects and safety profile of four different doses of granisetron (Kytril; SmithKline Beecham Pharmaceuticals, Philadelphia, PA) when administered as a single intravenous (IV) dose for prophylaxis of cisplatin-induced nausea and vomiting. Patients and Methods: One hundred eighty-four chemotherapy-naive patients receiving high-dose cisplatin (81 to 120 mg/m2) were randomized to receive one of four granisetron doses (5, 10, 20, or 40 μg/kg) administered before chemotherapy. Patients were observed on an inpatient basis for 18 to 24 hours, and vital signs, nausea, vomiting, retching, and appetite were assessed. Safety analyses included incidence of adverse experiences and laboratory parameter changes. Results: After granisetron doses of 5, 10, 20, and 40 μg/kg, a major response (≤ two vomiting or retching episodes, and no antiemetic rescue) was recorded in 23%, 57%, 58%, and 60% of patients, respectively, and a complete response (no vomiting or retching, and no antiemetic rescue) in 18%, 41%, 40%, and 47% of patients, respectively. There was a statistically longer time to first episode of nausea (P = .0015) and vomiting (P = .0001), and fewer patients were administered additional antiemetic medication in the 10-μg/kg dosing groups than in the 5-μg/kg dosing group. As granisetron dose increased, appetite return increased (P = .040). Headache was the most frequently reported adverse event (20%). Conclusion: A single 10-, 20-, or 40-μg/kg dose of granisetron was effective in controlling vomiting in 57% to 60% of patients who received cisplatin at doses greater than 81 mg/m2 and totally prevented vomiting in 40% to 47% of patients. There were no statistically significant differences in efficacy between the 10-μg/kg dose and the 20- and 40-μg/kg doses. Granisetron was well tolerated at all doses.

AB - Purpose: To assess the antiemetic effects and safety profile of four different doses of granisetron (Kytril; SmithKline Beecham Pharmaceuticals, Philadelphia, PA) when administered as a single intravenous (IV) dose for prophylaxis of cisplatin-induced nausea and vomiting. Patients and Methods: One hundred eighty-four chemotherapy-naive patients receiving high-dose cisplatin (81 to 120 mg/m2) were randomized to receive one of four granisetron doses (5, 10, 20, or 40 μg/kg) administered before chemotherapy. Patients were observed on an inpatient basis for 18 to 24 hours, and vital signs, nausea, vomiting, retching, and appetite were assessed. Safety analyses included incidence of adverse experiences and laboratory parameter changes. Results: After granisetron doses of 5, 10, 20, and 40 μg/kg, a major response (≤ two vomiting or retching episodes, and no antiemetic rescue) was recorded in 23%, 57%, 58%, and 60% of patients, respectively, and a complete response (no vomiting or retching, and no antiemetic rescue) in 18%, 41%, 40%, and 47% of patients, respectively. There was a statistically longer time to first episode of nausea (P = .0015) and vomiting (P = .0001), and fewer patients were administered additional antiemetic medication in the 10-μg/kg dosing groups than in the 5-μg/kg dosing group. As granisetron dose increased, appetite return increased (P = .040). Headache was the most frequently reported adverse event (20%). Conclusion: A single 10-, 20-, or 40-μg/kg dose of granisetron was effective in controlling vomiting in 57% to 60% of patients who received cisplatin at doses greater than 81 mg/m2 and totally prevented vomiting in 40% to 47% of patients. There were no statistically significant differences in efficacy between the 10-μg/kg dose and the 20- and 40-μg/kg doses. Granisetron was well tolerated at all doses.

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