ONDANSETRON VERSUS GRANISETRON IN THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING - RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL

Background. A single-institution, prospective, randomized open trial w as performed to compare ondansetron and granisetron in the prevention of chemotherapy-related nausea and vomiting. The effect of antemetic d rugs was analyzed indipendently for patients treated with highly emeto genic chemotherapy (Study 1), and those treated with moderately emetog enic regimens (Study 2). Methods. In Study 1, 182 patients treated wit h chemotherapeutic regimens containing high dose cisplatin (more than 70 mg/m(2)) were randomized to receive 24 mg of ondasentron intravenou sly (i.v.) or 3 mg of granisetron i.v. for the control of acute emesis . Patients treated with fractionated chemotherapy and those followed-u p for delayed emesis also received 8 mg of ondansetron orally twice a day or 3 mg of granisetron i.v. on the days after Day 1. In Study 2, 1 64 patients were randomized to receive either 16 mg of ondansetron i.v . or 3 mg of granisetron i.v. to prevent emesis in the first 24 hours. Results. In the ondansetron group in Study 1, a complete response (CR ) (i.e., no vomiting, nausea possible) from acute emesis was achieved in 52% of cases, a major response (MR) in 29%, and a minor response (M iR) in 14%. In the granisetron group in Study I, a CR was seen in 49% of patients, an MR in 24%, and an MiR in 12%. Failure was recorded in 5% and 15% of cases in the ondansetron and granisetron groups, respect ively. No statistically significant difference in any response categor y was seen between the two groups. In the ondansetron group, a complet e protection from delayed emesis was recorded in 39% of cases, an MR i n 32%, an MiR in 21%, and failure in 16%. In the granisetron arm, 36% of the patients had a CR, 22% had an MR, 14% had an MiR, and 14% exper ienced treatment failure. Again, these differences did not reach stati stical significance. In Study 2, no statistical significant difference was observed between the ondansetron arm and the granisetron arm, bot h for acute and delayed emesis. Both ondansetron and granisetron were tolerated very well by most patients, with no severe side effects. In the group of patients treated with ondansetron, however, the incidence of headache (9%) was higher than in the group treated with granisetro n (4%). Conclusions. These data suggest that although both ondansetron and granisetron are very effective drugs for the control of acute eme sis, their efficacy against delayed emesis is still not entirely satis factory.