PURPOSE: To compare the efficacy of oral granisetron, 1 mg and 2 mg, administered as one dose in patients who receive moderately emetogenic chemotherapy. PATIENTS AND METHODS: Chemotherapy-naïve patients, scheduled to receive intravenous cyclophosphamide (500 to 1200 mg/m2) or carboplatin (> or = 300 mg/m2), were stratified by dexamethasone/methylprednisolone use (+ DEX, n = 92) or nonuse (- DEX, n = 5). Patients were randomized to one dose of either 1 mg (n = 48) or 2 mg (n = 49) of granisetron administered 60 minutes before chemotherapy. Known important prognostic variables (gender, age, alcohol) were well balanced between groups. RESULTS: Using the most rigorous criterion of total control (no emetic episodes, no nausea, no rescue therapy during the first 24 hours), response rates were 54.2% (26/48) and 57.1% (28/49) in patients receiving 1 mg and 2 mg of granisetron, respectively (95% confidence interval, -0.17, 0.23). Total control rates in patients who received 1 mg and 2 mg of granisetron + DEX were also comparable: 57.8% (26/45) and 55.3% (26/47), respectively. Response rates were similar for the parameters of nausea, emesis, and complete response (no emetic episodes, no more than mild nausea, no antiemetic rescue). Among all patients, one (2.1%) who received 1 mg of granisetron and three (6.1%) who received 2 mg experienced severe nausea. The proportions of 1- and 2-mg-treated patients who received rescue therapy within the first 24 hours were 31.3% (15/48) and 34.7% (17/49), respectively. Reported adverse experiences were generally mild in severity. DISCUSSION: The results of this trial demonstrate good control of emesis with a single 1-mg dose of oral granisetron, with efficacy that compares favorably with that of a 2-mg dose.
RCT Entities:
PURPOSE: To compare the efficacy of oral granisetron, 1 mg and 2 mg, administered as one dose in patients who receive moderately emetogenic chemotherapy. PATIENTS AND METHODS: Chemotherapy-naïve patients, scheduled to receive intravenous cyclophosphamide (500 to 1200 mg/m2) or carboplatin (> or = 300 mg/m2), were stratified by dexamethasone/methylprednisolone use (+ DEX, n = 92) or nonuse (- DEX, n = 5). Patients were randomized to one dose of either 1 mg (n = 48) or 2 mg (n = 49) of granisetron administered 60 minutes before chemotherapy. Known important prognostic variables (gender, age, alcohol) were well balanced between groups. RESULTS: Using the most rigorous criterion of total control (no emetic episodes, no nausea, no rescue therapy during the first 24 hours), response rates were 54.2% (26/48) and 57.1% (28/49) in patients receiving 1 mg and 2 mg of granisetron, respectively (95% confidence interval, -0.17, 0.23). Total control rates in patients who received 1 mg and 2 mg of granisetron + DEX were also comparable: 57.8% (26/45) and 55.3% (26/47), respectively. Response rates were similar for the parameters of nausea, emesis, and complete response (no emetic episodes, no more than mild nausea, no antiemetic rescue). Among all patients, one (2.1%) who received 1 mg of granisetron and three (6.1%) who received 2 mg experienced severe nausea. The proportions of 1- and 2-mg-treated patients who received rescue therapy within the first 24 hours were 31.3% (15/48) and 34.7% (17/49), respectively. Reported adverse experiences were generally mild in severity. DISCUSSION: The results of this trial demonstrate good control of emesis with a single 1-mg dose of oral granisetron, with efficacy that compares favorably with that of a 2-mg dose.