CONTROL OF DELAYED NAUSEA AND VOMITING WITH GRANISETRON PLUS DEXAMETHASONE OR DEXAMETHASONE ALONE IN PATIENTS RECEIVING HIGHLY EMETOGENIC CHEMOTHERAPY - A DOUBLE-BLIND, PLACEBO-CONTROLLED, COMPARATIVE-STUDY

Background. The efficacies of granisetron plus dexamethasone and dexam ethasone alone in controlling delayed nausea and vomiting after cispla tin chemotherapy (greater than or equal to 69 mg/m(2)) were compared i n a multicentre, double-blind, placebo-controlled comparative study. P atients and methods. In all, 654 patients (of whom 619 were evaluable) received prophylactic granisetron plus dexamethasone before chemother apy on day 0; on day 1 complete responders and non-responders were ran domized separately to receive dexamethasone, 8 mg b.d. p.o., with eith er granisetron, 1 mg b.d. p.o., or matching placebo for six days. Resu lts. Over days 1-6 the complete response rates were 54.5% (dexamethaso ne group) and 52.1% (dexamethasone plus granisetron group). Response r ates were higher over days 4-6 (71.8% and 70.7%, respectively) than ov er days 1-3 (60.4% and 57.9%, respectively). Significantly more patien ts who responded to antiemetic treatment during day 0 were responders over days 1-6 (63% vs. 17%; P < 0.001). No other treatment-related dif ferences were found. Adverse events tended to be minor, with constipat ion and headache the most common. Overall, there were no significant d ifferences in the safety profiles of the two regimens, but constipatio n and abdominal pain were significantly more common in the dexamethaso ne plus granisetron group. Conclusions. Granisetron plus dexamethasone did not appear to confer additional benefit over use of dexamethasone alone in controlling delayed nausea and vomiting following cisplatin chemotherapy. Control of acute nausea and vomiting, however, appeared to be an important factor influencing delayed nausea and vomiting.