Dose-finding study of tropisetron in cisplatin-induced nausea and vomiting
| Autor: | J. Michel, K. M. de Bruijn, Lambert Stamatakis, S. Van Belle, Veronique Cocquyt, Harry Bleiberg |
|---|---|
| Rok vydání: | 1994 |
| Předmět: |
Adult
Male Indoles Vomiting Nausea medicine.drug_class medicine.medical_treatment Tropisetron Drug Administration Schedule 5-HT3 Receptor Antagonist Neoplasms medicine Humans Antiemetic Adverse effect Aged Aged 80 and over Chemotherapy business.industry Hematology Middle Aged Chemotherapy regimen Oncology Anesthesia Antiemetics Female Cisplatin medicine.symptom business medicine.drug |
| Zdroj: | Annals of Oncology. 5:821-825 |
| ISSN: | 0923-7534 |
| Popis: | Summary Background The purpose of these two studies was to define the optimal therapeutic dose of the 5-HT3 receptor antagonist tropisetron (Navoban®, ICS 205–930) in cisplatin-induced nausea and vomiting. Patients and methods In two multicentre, dose-finding studies of tropisetron in the prevention of cisplatin-induced emesis, cancer patients naive to chemotherapy or who had not vomited previously were randomly assigned to tropisetron 5, 10, 20 or 40 mg (study I, 143 patients) or 2 or 5 mg (study II, 74 patients), administered as a single intravenous dose over 15 minutes just before the start of chemotherapy. Results In study I total control of acute symptoms (no nausea and no vomiting) was achieved in, respectively, 66%, 50%, 64% and 50% in the 5-, 10-, 20- and 40-mg groups of patients. A total absence of vomiting alone was seen in, respectively, 71%, 51%, 61% or 58% of patients. None of the differences were statistically significant. In study II there was total acute control in 57% of patients in the 2-mg group and 63% in the 5-mg group (p ─ NS). Total or major control of vomiting (≤2 emetic episodes) was the primary endpoint in study II and was seen in 68% of patients for the 2-mg and 86% for the 5-mg group (p─0.055). In this study failures (> 3 vomiting) were rescued with a second infusion of tropisetron (5-mg fixed dose). Three of 8 rescue infusions administered in the 2-mg group prevented further vomiting whereas none of 5 were successful in the 5-mg group during course 1 of chemotherapy. The most frequently reported adverse effects (over all three courses) were headache (6.0% of 217 patients) hypertension (3.7%) and diarrhoea (2.8%). None of the 25 deaths which occurred during the two studies were attributable to tropisetron. Conclusions Thus, a single dose of tropisetron provides 24-hour protection against cisplatin-induced nausea and vomiting and is well tolerated. These studies do not allow a firm conclusion but suggest that 2 mg may be subtherapeutic and that 5 mg is as effective as higher doses. |
| Databáze: | OpenAIRE |
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