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

Abstract

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/m2. 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. Cancer 1994; 73:445–54.

Efficacy and Tolerability of Tropisetron in the Prevention of Cisplatin-induced Nausea and Vomiting in Advanced Non-small Cell Lung Cancer

“…The complete plus major control rates were 77%, 81%, 86%, 67% and 75% for cycles l to 5, respectively, which falls within the range of 53 -76% previously reported by other investigators (2 -6). In our study, the outcome for control of delayed nausea and vomiting was good, the complete plus major control rates were 82%, 69%, 72%, 73%, and 80% for cycles 1 -5, respectively, which was an improvement on the other reports (7,8). This may reflect the better control of acute nausea and vomiting plus the effect of oral tropisetron given on days 2-6.…”

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“…Finally two open, randomized, multicenter studies have been published [28,29]. The first compared tropisetron (5 mg i.v.…”

The antiemetic efficacy of granisetron plus dexamethasone, haloperidol and loracepam in breast cancer patients treated with high-dose chemotherapy with peripheral blood stem-cell support

“…There has been marked progress in the control of chemotherapy-induced emesis over the past few years. Clinical trials have confirmed the value of serotonin receptor antagonists in the prevention and treatment of acute drug-induced nausea and vomiting [3,[8][9][10]14]. In recent years there has been a market trend to increasing dose intensity in cancer chemotherapy, with or without peripheral blood stem-cell support.…”