Abstract
This double-blind multicentre study has been carried out in order to confirm the improvement of ondansetron's antiemetic efficacy when combined with a corticosteroid and to determine whether this increased efficacy is maintained over three chemotherapy courses. One hundred and two patients receiving their first course of cisplatin (50-120 mg m-2)-containing chemotherapy were randomised to receive one of the two following treatments: 8 mg OND i.v. injection and 120 mg MPD i.v. injection before chemotherapy, followed 8-12 h later by an 8 mg OND tablet and a 16 mg MPD tablet (oral treatment administered twice daily for 3-5 days): or 8 mg OND plus placebo i.v. injection before chemotherapy, followed by 8-12 h later by an 8 mg OND tablet and placebo p.o. (oral treatment administered twice daily for 3-5 days). The number of emetic episodes (EEs = vomits + retches) and the grade of nausea were recorded. Of the 101 patients studied (efficacy analysis), complete or major control (0-2 EEs) was experienced in 90.4% of patients in the first 24 h in the OND/MPD group compared with 71.4% of patients in the OND group during the first course. This difference in favour of OND/MPD was noted over the three courses and is statistically significant. In the control of delayed emesis (worst day between days 2 and 6) there is a trend in favour of the OND/MDP group during the first course [56.2% vs 43.2% for complete response (no emetic episodes)] which was statistically significant on courses 2 and 3. The global antiemetic control over the course was always in favour of OND/MPD, which leads to a better efficacy maintained over the three courses. Both treatments were well tolerated. The results of this study confirm the increased antimetic efficacy of ondansetron and methylprednisolone in combination in cisplatin-induced acute and delayed emesis which led to a better maintained efficacy over three repeated chemotherapy courses.
Highlights
In many cancer types, cisplatin is one of the most effective cytotoxic drugs currently available, but it is one of the most emetogenic (Hellenbrecht & Saller, 1986)
The aim of this study was to confirm the improvement in the antiemetic activity of ondansetron in combination with a corticosteroid on the day of the cisplatin administration, and on subsequent days; the combination was studied over a further two successive courses
The main characteristics of these 101 evaluable patients are shown in Table I: 49 patients were randomised to the Ondansetron group (OND) group and 52 patients to the OND/MPD group
Summary
The aim of this study was to confirm the improvement in the antiemetic activity of ondansetron in combination with a corticosteroid on the day of the cisplatin administration, and on subsequent days; the combination was studied over a further two successive courses
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