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Annals of Oncology 8:181-185, 1997
© 1997 European Society for Medical Oncology


research-article

The role of the 5-HT3 antagonists ondansetron and dolasetron in the control of delayed onset nausea and vomiting in patients receiving moderately emetogenic chemotherapy

J. L. Pater1,, W. S. Lofters2, B. Zee1, E. Dempsey3, D. Walde4, J.-P. Moquin5, K. Wilson6, P. Hoskins7, R. M. Guevin8, S. Verma9, R. Navari10, J. E. Krook11, J. Hainsworth12, M. Palmer1 and C. Chin3

1NCIC Clinical Trials Group, Queen's University Kingston, USA
2Kingston Regional Cancer Centre Kingston, USA
3Hoechst-Marion Roussel Canada Inc Montreal, USA
4Algoma Group Health Centre, Sault Ste Marie, USA
5Hospital du Sacre-Coeur Montreal, USA
6BCCA - Vancouver Island Cancer Centre Victoria, USA
7BCCA - Vancouver Cancer Centre Vancouver, USA
8Hospital Saint-Luc Montreal, USA
9ORCC-General Division Ottawa, Canada, USA
10Simon-Williamson Clinic Birmingham, AL, USA
11Duluth CCOP Duluth, MN, USA
12Sarah Cannon Cancer Centre, Nashville Nashville, TN, USA

Correspondence to: Joseph L. Pater, MD, MSc, FRCP(C) Director, NCIC Clinical Trials Group Queen's University 82–84 Barrie Street Kington, ON K7L 3N6 Canada

BACKGROUND:: 5-HT3 antagonists are effective in reducing the acute nausea and vomiting caused by cancer chemotherapy. However, it is not clear whether continuing these agents beyond twenty four hours is useful in controlling emesis on days two to seven after chemotherapy.

PATIENTS AND METHODS:: Four hundred seven patients receiving moderately emetogenic chemotherapy who had been given dexamethasone 8 mg i.v. and either ondansetron 32 mg i.v. or dolasetron 2.4 mg/kg i.v. were randomized to continue either an oral form of their 5-HT3 antagonist (ondansetron 8 mg b.i.d. or dolasetron 200 mg daily) plus dexamethasone 8 mg p.o. daily or dexamethasone alone for days two to seven. Endpoints assessed by self-report were: 1) complete control (no vomiting, no rescue medications, no missing data) of emesis; 2) nausea severity; and 3) quality-of-life as measured by the EORTC QLQ-C30.

RESULTS:: Continuation of 5-HT3 antagonists improved slightly, but not significantly, the complete control rate (47% vs. 41%; P = 0.24 one-sided) after chemotherapy. However, mean nausea severity was significantly (P = 0.015 one sided) reduced (by 3 mm on a 10 cm scale) on the combined arm. Minimal differences in quality of life were observed

CONCLUSION:: The benefit of continuing 5-HT3 antagonists beyond 24 hours is modest and the merits of routine use in these circumstances debatable.

chemotherapy, clinical trial, emesis, 5-HT3, antagonists


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