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Dexamethasone Alone or in Combination with Ondansetron for the Prevention of Delayed Nausea and Vomiting Induced by Chemotherapy

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The Italian Group for Antiemetic Research
Abramson Cancer Center of the University of Pennsylvania
Last Modified: November 1, 2001

Reviewers: Li Liu, MD
Source: The New England Journal of Medicine, volume 342, 1554-1559, (May) 2000

Introduction

Nausea and vomiting are among the most distressing side effects of chemotherapy for cancer, but the best way to prevent these symptoms is unclear. Some studies have found that ondansetron and dexamethasone were equally effective in controlling acute nausea and vomiting but that dexamethasone was better in the control of delayed nausea. This double-blind, randomized, multicenter study investigated early treatment of nausea and vomiting as well as the efficacy of several regimens for the prevention of delayed emesis

Materials and Methods

A total of 705 were enrolled into this study. All the patients received prophylactic ondansetron combined with dexamethasone prior to chemotherapy. The low-risk patients (the group of patients who were protected against moderate-to-severe nausea and vomiting on the first day) were randomly assigned to oral placebo, dexamethasone, or ondansetron in combination with dexamethasone. The high-risk patients (those who were not protected against symptoms on day one) were randomized to either dexamethasone alone or in combination with ondansetron.

Results

• The combination of ondansetron and dexamethasone was effective in protecting 90% of patients from vomiting and 70.8% of patients from nausea during the first 24 hours after chemotherapy.
• Among the patients in the low-risk group, ondansetron combined with dexamethasone or dexamethasone alone were significantly more effective than placebo, 91.8%, 87.4%, and 76.8%, respectively.
• Of patients in the high-risk group, only 23.3% treated with dexamethasone alone and 40.9% treated with the combination of drugs were protected against delayed-onset nausea and vomiting.

Discussion

This study demonstrated that controlling emesis on the first day with combination of ondansetron and dexamethasone alone appeared to be an effective way to prevent delayed emesis in patients receiving chemotherapy. For low-risk patients (those who were protected on day one), dexamethasone was effective against delayed emesis.