Antiemetic efficacy of single-dose oral granisetron (1 mg vs 2 mg) with moderately emetogenic chemotherapy.
OBJECTIVE
To compare the efficacy of oral granisetron, 1 mg and 2 mg, administered as one dose in patients who receive moderately emetogenic chemotherapy.


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.


CONCLUSIONS
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.
Hesketh
P J
PJ
Division of Hematology/Oncology, St. Elizabeth's Medical Center, Boston, Massachusetts 02135-2997, USA.
Crews
J R
JR
Cohen
R
R
Blackburn
L M
LM
Friedman
C J
CJ
D000284:Administration, Oral; D000328:Adult; D000367:Age Factors; D000428:Alcohol Drinking; D000970:Antineoplastic Agents / Q000627:therapeutic use; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D016190:Carboplatin / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000627:therapeutic use*; D003907:Dexamethasone / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D017829:Granisetron / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009369:Neoplasms / Q000188:drug therapy*; D012702:Serotonin Antagonists / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D012737:Sex Factors
D000970:Antineoplastic Agents; D018906:Antineoplastic Agents, Alkylating; D018931:Antineoplastic Agents, Hormonal; D016190:Carboplatin; D003520:Cyclophosphamide; D003907:Dexamethasone; D005938:Glucocorticoids; D017829:Granisetron; D008775:Methylprednisolone; D012702:Serotonin Antagonists