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5-Hydroxytryptamine-3 Receptor Antagonist With or Without Short-Course Dexamethasone in the Prophylaxis of Radiation Induced Emesis: A Placebo-Controlled Randomized Trial of the National Cancer Institute of Canada Clinical Trials Group (SC19)

Rebecca K.S. Wong, Nancy Paul, Keyue Ding, Marlo Whitehead, Michael Brundage, Anthony Fyles, Derek Wilke, Abdenour Nabid, Andre Fortin, Don Wilson, Michael McKenzie, Ida Ackerman, Luis Souhami, Pierre Chabot, Joseph Pater

From the National Cancer Institute of Canada Clinical Trials Group; Kingston Regional Cancer Centre, Queen's University, Kingston; Queen Elizabeth II Health Sciences Centre, Nova Scotia; Centre Hospitalier Universitaire de Sherbrooke Hopital Fluerimont, Sherbrooke; Centre Hospitalier Universitaire de Quebec Pavillon Hotel Dieu de Quebec, Hopital Maisonneuve Rosemont; McGill University, Department of Oncology; Centre Hospitalier de L'Universite de Montreal Hopital Notre-Dame, Quebec; Toronto Sunnybrook Regional Cancer Centre; University of Toronto; Princess Margaret Hospital, University Health Network, University of Toronto, Toronto; British Columbia Cancer Agency, Vancouver Centre; British Columbia Cancer Agency Fraser Valley Centre; British Columbia Cancer Agency Cancer Centre for the Southern Interior; British Columbia Cancer Agency Vancouver Island Cancer Centre, British Columbia, Canada; London Regional Cancer Centre, London; Northwestern Ontario Regional Cancer Centre, Sudbury; Cross Cancer Institute, Edmonton, Canada

Address reprint requests to Rebecca K.S. Wong, MBChB MSc, Radiation Medicine Program, Princess Margaret Hospital, 610 University Avenue, Toronto M5G 2M9 Canada; e-mail: Rebecca.wong{at}rmp.uhn.on.ca

PURPOSE: To evaluate the effectiveness of prophylactic dexamethasone for the control of radiation induced emesis (RIE) when added to ondansetron during days 1 to 5 of fractionated radiotherapy. The study had two hypotheses: ondansetron and dexamethasone could provide superior control of RIE over ondansetron alone during the prophylactic period and; the combination could provide sustained control of RIE during subsequent fractions of radiotherapy.

PATIENTS AND METHODS: Between May 2001 to Jan 2004, 211 patients receiving radiotherapy ( 15 fractions) to the upper abdomen were randomly assigned to receive ondanstron 8 mg bid with either dexamethasone 4 mg daily or placebo during fractions 1 to 5. Rescue antiemetics were provided.

RESULTS: During the prophylactic period there was a trend for improved complete control of nausea in the dexamethasone arm (50% v 38%; P = .06) while complete and partial control of emesis, average nausea score, and use of rescue medications were similar in the two groups. During the overall study period patients receiving dexamethasone had better complete control of emesis (23% v 12%; P = .02) and a lower average nausea score (0.28 v 0.39; P = .03); there was a trend towards less use of rescue medications with dexamethasone (70% v 80%; P = .09); other outcomes were similar on the two arms. Quality of life analysis showed a significant difference in appetite.

CONCLUSION: The addition of dexamethasone to ondansetron as prophylaxis provides a modest improvement in protection against RIE during moderately emetogenic fractionated radiotherapy. It is a potentially useful addition to 5-hydroxytryptamine-3 receptor antagonists in this setting.

Supported by GlaxoSmithKline.

Presented in part at the Annual Meeting of the European Society of Therapeutic Radiation Oncology, Amsterdam, 2004; and the Annual Meeting of the Multinational Association of Supportive Care in Cancer, Geneva, 2005.

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