Dose-finding study of tropisetron in cisplatin-induced nausea and vomiting
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 cisp...
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Published in | Annals of oncology Vol. 5; no. 9; pp. 821 - 825 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
Oxford
Oxford University Press
01.11.1994
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Subjects | |
Online Access | Get full text |
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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 naïve 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. |
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Bibliography: | Correspondence to: Dr. S. Van Belle, University Hospital of Gent, DePintelaan 185, 9000 Gent, Belgium istex:E0F7392F93FF1DB927BDAFFEBD755CC37A0012D7 ark:/67375/HXZ-HLL99SVQ-J ArticleID:5.9.821 |
ISSN: | 0923-7534 1569-8041 |
DOI: | 10.1093/oxfordjournals.annonc.a059011 |