COMPARISON OF GRANISETRON, ONDANSETRON, AND TROPISETRON IN THE PROPHYLAXIS OF ACUTE NAUSEA AND VOMITING INDUCED BY CISPLATIN FOR THE TREATMENT OF HEAD AND NECK-CANCER - A RANDOMIZED CONTROLLED TRIAL

BACKGROUND. A single-institution, prospective, randomized, open contro lled trial was carried out on head and neck cancer patients to compare granisetron (GRA), ondansetron (OND), and tropisetron (TRO) in the pr evention of cisplatin-induced acute nausea and vomiting. All patients were chemotherapy-naive and treated with cisplatin on Day 1 (80 to 100 mg/m(2)). METHODS. One hundred seventeen patients were treated for a total of 463 cycles of cisplatin-based chemotherapy and randomized to receive 24 mg of OND intravenously (i.v.), 3 mg of GRA i.v., or 5 mg o f TRO i.v. for the control of acute nausea and emesis. RESULTS. In the GRA group, complete response (CR) was obtained in 119 of 165 cycles ( 72.1%), major response (MR) in 32 cycles (19.4%), minor response (MiR) in 5 cycles (3%), and a failure (F) in 9 cycles (5.5%). In the OND gr oup, CR was obtained in 110 of 150 cycles (73.3%), MR in 31 cycles (20 .7%), MiR in 2 cycles (1.3%), and F in 7 cycles (4.7%). In the TRO gro up, CR was obtained in 100 of 148 cycles (67.6%), MR in 26 cycles (17. 6%), MiR in 15 cycles (10.1%), and F in 7 cycles (4.7%). Major efficac y (CR + MR) was obtained in 151 of 165 cycles (91.5%) for GRA, in 141 of 150 cycles (94.0%) for OND, and in 126 of 148 cycles (85.2%) for TR O. The difference in major efficacy between OND and TRO was statistica lly significant. When comparing MiR, both GRA and OND were more effect ive than TRO. No other significant differences were observed among the three antiemetic agents. CONCLUSIONS. Although our results were achie ved in an open trial, they show that GRA and OND are equally effective antiemetic agents in the prevention of cisplatin-induced acute nausea and vomiting. TRO provides almost the same protection but is not as e ffective as OND for major efficacy. All three antiemetics can be admin istered safely to patients undergoing chemotherapy with cisplatin at d oses of 80 mg/m(2) or more. (C) 1996 American Cancer Society.