[A comparative study of the effect of granisetron and a combination of granisetron plus steroids on cancer chemotherapy induced emesis]

Effects of 40 micrograms/kg of granisetron monotherapy (K group) and concurrent therapy with a steroid (KS group) on acute and delayed emesis induced by cancer chemotherapy which included CDDP at a dose of 60 mg/m2 or more were compared in random clinical trials under the central registration method. In KS group, either 500 mg of methylprednisolone succinate or 8 mg of dexamethasone phosphate was given prior to granisetron administration. Clinical symptoms such as vomiting, nausea and anorexia were better in KS group than in K group, on any day from day 1 to day 7, and there was a statistically significant difference on day 1 and day 2. The cumulative total control rate throughout the period of seven days was also significantly higher in KS group. KS group was rated higher in the final clinical evaluation based on doctor's impressions, but there was no significant difference between the two groups. Augmented antiemetic effect of granisetron by concurrent therapy with a steroid was most notably demonstrated in male patients under 60 years of age. The antiemetic effect at the acute stage was proven to influence the final clinical effectiveness, thus suggesting the importance of antiemetic therapy of acute emesis. Adverse reactions were seen in two out of 122 patients (1.6%). They were slight headache and moderate diarrhea in 1 case each, both of which disappeared soon, confirming the high safety profile of granisetron.