A RANDOMIZED, MULTICENTER STUDY COMPARING THE EFFICACY AND TOLERABILITY OF TROPISETRON, A NEW 5-HT3 RECEPTOR ANTAGONIST, WITH A METOCLOPRAMIDE-CONTAINING ANTIEMETIC COCKTAIL IN THE PREVENTION OF CISPLATIN-INDUCED EMESIS

Background. Chemotherapy-induced emesis is one of the most disturbing side effects in cancer therapy. Thus, antiemetic treatment is a mandatory adjunct in emetogenic chemotherapy. Methods. Tropisetron (Navoban, Sandoz Pharma Ltd., Basel, Switzerland), a new 5-HT3, receptor antagonist, was compared in a randomized multicenter trial with a high-dose metoclopramide-dexamethasone cocktail for the prevention of nausea and emesis during cisplatin-containing chemotherapy. Two hundred fifty-nine chemotherapy-naive patients were included and followed during two consecutive courses. The main cancer types were gynecologic tumors, followed by lung cancer, head and neck cancer, and bladder cancer. The cisplatin dose usually was in the range of 50-89 mg/m(2). The efficacy and quality of life assessments and the safety recordings were done during the first 6 days of both courses of chemotherapy. Results. Acute vomiting was prevented in 63-64% of patients by both antiemetic regimens. The total rate of control of vomiting increased from 63% on day 1 to 93% on day 6 in the group receiving tropisetron. Acute nausea was prevented in 40% of the patients with tropisetron monotherapy and in 61% of patients receiving the antiemetic cocktail. With regard to delayed nausea, there were no significant differences between the two antiemetic regimens. Mild headache and constipation were more frequently associated with tropisetron, and extrapyramidal side effects and sedation were associated with the antiemetic cocktail. Conclusions. Tropisetron was easier to administer and better tolerated than the cocktail, and it seems to be a highly efficacious and safe new antiemetic drug.