This Article Full Text Full Text (PDF) Erratum (v22,p2038) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Search for Related Content PubMed PubMed Citation Social Bookmarking                            What's this?

Randomized, Double-Blind, Dose-Finding Study of Dexamethasone in Preventing Acute Emesis Induced by Anthracyclines, Carboplatin, or Cyclophosphamide:

From the Italian Group for Antiemetic Research

Address reprint requests to Fausto Roila, MD, Medical Oncology Division, Policlinico Hospital, 06122 Perugia, Italy; e-mail: roila.fausto{at}libero.it

PURPOSE: Different doses and schedules of dexamethasone, combined with a 5-HT3 antagonist, are used to prevent acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide. Therefore, we planned a randomized, double-blind, dose finding study aimed to identify the preferred dose and schedule of dexamethasone.

PATIENTS AND METHODS: All consecutive chemotherapy-naive patients enrolled onto study were randomly assigned to receive for the prevention of acute emesis, during the first 24 hours, one of the following dexamethasone regimens, in combination with ondansetron 8 mg intravenously (IV): for arm A, 8 mg IV before chemotherapy plus 4 mg orally every 6 hours for four doses, starting at the same time of the chemotherapy; for arm B, 24 mg IV single dose before chemotherapy; and for arm C, 8 mg IV single dose before chemotherapy. All patients received from day 2 to 5 oral dexamethasone 4 mg bid.

RESULTS: A total of 587 patients were enrolled, and 585 were assessed according to the intention-to-treat principle (195 patients in each arm). The rate of complete protection from acute vomiting and nausea, respectively, was not significantly different among the three groups (arm A, 84.6% and 66.7%; arm B, 83.6% and 56.9%; arm C, 89.2% and 61.0%), nor was the rate of complete protection from delayed vomiting and nausea, respectively (arm A, 81.0% and 46.7%; arm B, 81.3% and 45.1%; arm C, 79.8% and 46.1%). The incidence of delayed vomiting and nausea was strictly dependent on the presence of acute vomiting and nausea. Adverse events were mild and not significantly different among the three groups.

CONCLUSION: Dexamethasone 8 mg single dose IV before chemotherapy, in combination with a 5-HT3 antagonist, should be considered the preferred dose to prevent acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide.

Presented at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago IL, May 31-June 3, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				P. J. Hesketh Chemotherapy-Induced Nausea and Vomiting N. Engl. J. Med., June 5, 2008; 358(23): 2482 - 2494. [Full Text] [PDF]

				K. Jordan, C. Sippel, and H.-J. Schmoll Guidelines for Antiemetic Treatment of Chemotherapy-Induced Nausea and Vomiting: Past, Present, and Future Recommendations Oncologist, September 1, 2007; 12(9): 1143 - 1150. [Abstract] [Full Text] [PDF]

				S. Grunberg Antiemetic activity of corticosteroids in patients receiving cancer chemotherapy: dosing, efficacy, and tolerability analysis Ann. Onc., February 1, 2007; 18(2): 233 - 240. [Abstract] [Full Text] [PDF]

				M. G. Kris, P. J. Hesketh, M. R. Somerfield, P. Feyer, R. Clark-Snow, J. M. Koeller, G. R. Morrow, L. W. Chinnery, M. J. Chesney, R. J. Gralla, et al. American Society of Clinical Oncology Guideline for Antiemetics in Oncology: Update 2006 J. Clin. Oncol., June 20, 2006; 24(18): 2932 - 2947. [Abstract] [Full Text] [PDF]

				The Antiemetic Subcommittee of the Multinational A Prevention of chemotherapy- and radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference Ann. Onc., January 1, 2006; 17(1): 20 - 28. [Abstract] [Full Text] [PDF]

				M. T Holdsworth and T. Vo-Nguyen Employment of Substandard Antiemetic Prophylaxis in Recent Trials of Chemotherapy-Induced Nausea and Vomiting Ann. Pharmacother., November 1, 2005; 39(11): 1903 - 1910. [Abstract] [Full Text] [PDF]