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From December 1992 to July 1994, 973 consecutive patients scheduled to receive for the first time cisplatin at doses ≥ 50 mg/m 2 , used alone or in combination with other antineoplastic agents, entered a doubleblind multicenter randomized study comparing ondansetron (OND) 8 mg iv vs granisetron (GRAN) 3 mg iv, both diluted in 50 ml normal saline and administered in 15 minutes, 30 minutes before chemotherapy. Dexamethasone (DEX) 20 mg iv was added to the 5-HT 3 antagonists and administered in 15 min, 45 min befure chemotherapy. Nine hundred and sixty-six patients (483 receiving OND and 483 GRAN) were evaluable for intention to treat analysis. Patient characteristics were well balanced between the two antiemetic treatments. Complete protection from acute vomiting/nausea was obtained in 383 (79.3%)/348 (72.1%) of patients receiving OND and in 386 (79.9%)/347 (71.8%) of those receiving GRAN. During day 2–4 after chemotherapy patients received the same antiemetic prophylaxis for delayed emesis (metoclopramide 20 mg 4 times/day + DEX 8 mg im × 2 on day 2–3 and 4 mg im × 2 on day 4). Complete protection on day 2–6 from vomiting/nausea was obtained in 69.7%/52.9% and 70.0%/49.6%, respectively. Adverse events were mild and not significantly different between the two antiemetic regimens. In conclusion, OND 8 mg and GRAN 3 mg, both combined with DEX, showed similar efficacy and tolerability in the prevention of acute and delayed cisplatin-induced emesis; therefure, the choice between them should be made on the basis of acquisition costs. Supported by AUCC (Associazione Umbra Contro il Cancro).