PURPOSE: A single 3 mg or 40 μg/kg intravenous dose of granisetron combined with dexamethasone is routinely used in several countries, although the antiemetic guidelines have recommended granisetron at the dose of 1 mg or 10 μg/kg. A randomized, multicenter trial was conducted to determine the optimal intravenous granisetron dose, 1 or 3 mg, in cancer patients receiving emetogenic chemotherapy. METHODS: We enrolled 365 patients and randomly assigned them to receive intravenous granisetron 3 mg (3-mg group) or 1 mg (1-mg group), combined with dexamethasone at an adequate dose fixed as per the emetic risk category. The primary end point was the proportion of patients with a complete response during the first 24 h after chemotherapy. RESULTS: The study demonstrated that 1 mg of granisetron was not inferior in effect to 3 mg. For the primary end point, 359 patients were evaluable according to the modified intention-to-treat (ITT) analysis. Complete protection was achieved in the modified ITT population, 90.6% and 88.8% for the 3- and 1-mg groups, respectively (p < 0.01 for non-inferiority). CONCLUSIONS: This study showed that 1 mg granisetron is not inferior to 3 mg when both doses are combined with dexamethasone. Therefore, 1-mg dose of intravenous granisetron should be the recommended prophylactic regimen for the prevention of acute emesis.
RCT Entities:
PURPOSE: A single 3 mg or 40 μg/kg intravenous dose of granisetron combined with dexamethasone is routinely used in several countries, although the antiemetic guidelines have recommended granisetron at the dose of 1 mg or 10 μg/kg. A randomized, multicenter trial was conducted to determine the optimal intravenous granisetron dose, 1 or 3 mg, in cancerpatients receiving emetogenic chemotherapy. METHODS: We enrolled 365 patients and randomly assigned them to receive intravenous granisetron 3 mg (3-mg group) or 1 mg (1-mg group), combined with dexamethasone at an adequate dose fixed as per the emetic risk category. The primary end point was the proportion of patients with a complete response during the first 24 h after chemotherapy. RESULTS: The study demonstrated that 1 mg of granisetron was not inferior in effect to 3 mg. For the primary end point, 359 patients were evaluable according to the modified intention-to-treat (ITT) analysis. Complete protection was achieved in the modified ITT population, 90.6% and 88.8% for the 3- and 1-mg groups, respectively (p < 0.01 for non-inferiority). CONCLUSIONS: This study showed that 1 mg granisetron is not inferior to 3 mg when both doses are combined with dexamethasone. Therefore, 1-mg dose of intravenous granisetron should be the recommended prophylactic regimen for the prevention of acute emesis.
Authors: I Sekine; Y Nishiwaki; R Kakinuma; K Kubota; F Hojo; T Matsumoto; H Ohmatsu; M Yokozaki; T Kodama Journal: Jpn J Clin Oncol Date: 1996-06 Impact factor: 3.019
Authors: S Ozono; E Okajima; Y K Hirao; O Natsume; Y Kaneko; S Ohara; S Tabata; S Watanabe; H Aoyama; K Sasaki; H Matsuki; K Takashima; Y Maruyama; M Yoshikawa; K Yamada; H Momose; T Hiramatsu; Y Hayashi; K Babaya; T Shiomi Journal: Gan To Kagaku Ryoho Date: 1997-02
Authors: Mark G Kris; Paul J Hesketh; Mark R Somerfield; Petra Feyer; Rebecca Clark-Snow; James M Koeller; Gary R Morrow; Lawrence W Chinnery; Maurice J Chesney; Richard J Gralla; Steven M Grunberg Journal: J Clin Oncol Date: 2006-05-22 Impact factor: 44.544