1206 Comparison of granisetron vs ondansetron vs tropisetron in the prophylaxis of acute nausea and vomiting induced by highly emetogenic chemotherapy (high-dose cisplatin) for treatment of primary head and neck cancer: An open cross-over randomized controlled trial (RCT)

A two-centre prospective randomized open cross-over study to compare granisetron (Gra) vs ondansetron (Ond) vs tropisetron (Tro) in the prevention of high-dose cisplatin-induced nausea and vomiting was carried out. The notable characteristics of our study were: all patients were very homogeneous for tumor site (head and neck cancer), all were treated with high-dose (80 to 100 mg/sqm) cisplatin on day 1 and all were chemotherapy-naive. 141 patients for a total number of 541 chemotherapy cycles containing high-dose cisplatin were randomized to receive 24 mg of Ond intravenously (i.v.) or 3 mg of Gra i.v. or 5 mg of Tro i.v. for the control of acute nausea and emesis. In the Gra group in 138 out of 193 cycles (71.5%) the patients experienced a complete response (CR), in 34 cycles (17.6%) a major response (MR), in 9 cycles, (4.7%) a minor response (MiR) and in 12 cycles (6.2%) a failure (F). In the Ond group in 126 out of 176 cycles (71.6%) the patients experienced a CR, in 35 cycles (19.9%) an MR, in 5 cycles (2.8%) a MiR and in 10 cycles (5.7%) a F. In the Tro group in 115 out of 172 cycles (66.9%) the patients experienced a CR, in 30 cycles (17.4%) a MR, in 18 cycles (10.5%) a MiR and in 9 cycles (5.2%) a F. The major efficacy (CR + MR) was achieved in 172 out of 193 cycles (89.1%) for Gra, in 161 out of 176 cycles (91.5%) for Ond and in 145 out of 172 cycles (84.3%) for Tro. The statistical analysis could detect a significant difference as for major efficacy only between Ond and Tro (P Work supported by CNR, Rome, AP. ACRO, Contract No. 94.01157.PF39.