Randomized, double-blind comparison of ondansetron versus ondansetron plus metopimazine as antiemetic prophylaxis during platinum-based chemotherapy in patients with cancer.

Abstract

PURPOSE:

To investigate the antiemetic effect and tolerability of the 5-hydroxytryptamine3(5-HT3) antagonist ondansetron plus the dopamine D2 antagonist metopimazine versus ondansetron alone in patients receiving platinum-based chemotherapy.

PATIENTS AND METHODS:

One hundred eleven chemotherapy-naive patients who were scheduled to receive two consecutive courses of platinum-based chemotherapy were randomized between ondansetron 8 mg intravenously (IV) followed by 8 mg orally twice a day plus metopimazine 35 mg/m2 as a 24-hour continuous infusion followed by 30 mg orally four times a day for 4 days, or ondansetron plus placebo. The study used a double-blind, crossover, placebo-controlled design.

RESULTS:

Ninety-four patients completed the crossover. Complete response (CR; no emetic episodes) was obtained on day 1 in 77.7% of the patients who received the combination versus 50.0% of those who received ondansetron alone (P = .00002), and in 51.7% versus 31.0% on days 2 to 6 (P = .0009). The overall CR (days 1 to 6) was 48.9% versus 25.3% (P = .0002). Additionally, significantly less nausea was observed with the combination on day 1 (P = .0002), days 2 to 6 (P = .0001), and days 1 to 6 (P = .00004). Patient preference was 63.6% for the combination and 13.6% for ondansetron alone; 22.7% expressed no treatment preference (P < .0001; therapeutic gain 50.0%; 95% confidence interval [CI], 31.6% to 68.4%). Adverse reactions were mild and without significant differences between the two treatments.

CONCLUSION:

Metopimazine plus ondansetron was significantly superior to ondansetron alone, concerning all efficacy parameters assessed, in patients who received platinum-based chemotherapy.

• Authors: J Herrstedt, T Sigsgaard, J Handberg, B M Schousboe, M Hansen, P Dombernowsky
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 15 Issue 4 Pg. 1690-6 (Apr 1997) ISSN: 0732-183X [Print] United States
• PMID: 9193370 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiemetics
• Antineoplastic Agents
• Isonipecotic Acids
• Platinum Compounds
• metopimazine
• Ondansetron
• Carboplatin
• Cisplatin

Topics

• Adult
• Aged
• Antiemetics (therapeutic use)
• Antineoplastic Agents (adverse effects)
• Carboplatin (adverse effects)
• Cisplatin (adverse effects)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Isonipecotic Acids (therapeutic use)
• Male
• Middle Aged
• Nausea (chemically induced, prevention & control)
• Neoplasms (drug therapy)
• Ondansetron (therapeutic use)
• Platinum Compounds (adverse effects)
• Severity of Illness Index
• Treatment Outcome
• Vomiting (chemically induced, prevention & control)