USE OF DEXAMETHASONE AND GRANISETRON IN THE CONTROL OF DELAYED EMESISFOR PATIENTS WHO RECEIVE HIGHLY EMETOGENIC CHEMOTHERAPY

Purpose: To evaluate the roles of granisetron and dexamethasone for em esis control on days 2 through 7 after the administration of cisplatin in doses of 50 mg/m(2) or greater to patients who had not previously received chemotherapy. Patients and Methods: Four hundred thirty-five eligible and assessable patients were randomized to one of two arms in a double-blind fashion: arm A; granisetron 3 mg intravenous (IV) plus dexamethasone 10 mg IV prechemotherapy followed by granisetron 1 mg o rally at 6 and 12 hours, then granisetron 1 mg orally and dexamethason e 8 mg orally twice daily on days 2 through 7 (219 patients); arm B; a s in arm A but with placebo substituted for granisetron on days 2 thro ugh 7 (216 patients). All patients completed diaries in which episodes of emesis and severity of nausea were recorded. Results: The addition of granisetron on days 2 through 7 had no discernable impact on nause a and vomiting during this period. Conclusion: The administration of a 5-hydroxytryptamine(3), receptor (5-HT3) antagonist, in this case gra nisetron, after 24 hours conferred no benefit. This negative result ne eds to be assessed in light of conflicting literature, but at present it does not appear that the routine use of these drugs in this setting is justified. (C) 1998 by American Society of Clinical Oncology.