METHODS: All patients were treated with chemotherapeutic regimens containing
cisplatin greater than or equal to 80 mg/m2 and received
antiemetic therapy with
granisetron 3 mg intravenously for the control of acute
emesis. Patients who responded to treatment during the first 24 hours were randomized to receive (1)
metoclopramide (0.5 mg/kg) intramuscularly three times daily plus
methylprednisolone (125 mg) intramuscularly once a day or (2)
granisetron (1 mg) orally twice daily or (3) oral
granisetron (1 mg) orally plus
methylprednisolone (125 mg) intramuscularly from days 2 to 5.
RESULTS: Of the patients treated with
metoclopramide plus
methylprednisolone (n = 92), 53% had complete protection from delayed
emesis, 16% a major response, 15% a minor response, and 15% no response. Of the patients treated with
granisetron alone (n = 84), 33% had a complete response, 21% a major response, 23% a minor response, and 21% no response. In the patients treated with orally administered
granisetron plus intramuscularly administered
methylprednisolone (n = 86), 47% had a complete response, 17% a major response, 23% a minor response, and 13% no response. These differences reached statistical significance only when the complete response rate achieved in the
metoclopramide plus
methylprednisolone group was compared with that recorded in the oral
granisetron group (P = 0.012). Moreover, the
metoclopramide plus
methylprednisolone and the orally administered
granisetron plus
corticosteroid arms were superior to the orally administered
granisetron alone arm in preventing
nausea (P < 0.038 and P < 0.002, respectively). No extrapyramidal side effects were noted for the
granisetron alone and the
granisetron plus
methylprednisolone arms, whereas 6% of patients treated with
metoclopramide had extrapyramidal adverse effects.
Headache was recorded in 8% of patients treated with
granisetron alone, in 9% treated with
granisetron plus
methylprednisolone, and in 3% treated with
metoclopramide plus
methylprednisolone.
CONCLUSIONS: