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Annals of Oncology 2:681-686, 1991
© 1991 European Society for Medical Oncology

research-article

Original article: A randomized, double-blinded study comparing six doses of batanopride (BMY-25801) with methylprednisolone in patients receiving moderately emetogenic chemotherapy

J. Rusthoven1, J. Pater2, L. Kaizer4, K. Wilson5, D. Osoba8, J. Latreille10, B. Findlay9, W. S. Lofters7, D. Warr6, F. Laberge11, T. Vandenberg12, B. Zee2, J. Goodlow3, D. Johnston2 and L. Smaldone3

1From Department of Medicine, McMaster University, Hamilton Regional Cancer Centre Canada
2From Department of Medicine, National Cancer Institute of Canada Clinical Trials Group Canada
3From Department of Medicine, Bristol-Myers Squibb Canada
4From Department of Medicine, University of Toronto, Credit Valley Hospital Canada
5From Department of Medicine, University of British Columbia, British Columbia Cancer Agency, Victoria Clinic Canada
6From Department of Medicine, University of Toronto, Princess Margaret Hospital Canada
7From Department of Medicine, Queens University, Kingston Regional Cancer Centre Canada
8From Department of Medicine, University of British Columbia, British Columbia Cancer Agency Canada
9From Department of Medicine, Hotel Dieu Hospital Canada
I0From Department of Medicine, Hotel Dieu Hospital, University of Montreal Canada
11From Department of Medicine, Laval University Canada
12From Department of Medicine, University of Western Ontario, London Regional Cancer Centre Canada

Correspondence to: James J. Rusthoven, M.D., Hamilton Regional Cancer Centre, 711 Concession Street, Hamilton, Ontario, Canada L8V 1C3

Several agents in a new class of antiemetic compounds, 5-hydroxytryptamine (5-HT3) antagonists, have shown promise as effective antiemetics with fewer side effects than metoclopramide. One of these agents, batanopride, produced no severe toxicity at doses that prevented emesis due to chemotherapy in early Phase I trials. We conducted a randomized, double-blinded, 7 arm clinical trial to: (1) identify the presence of a dose-response for complete protection from emesis, and (2) compare batanopride with a standard antiemetic, methyl-prednisolone if a dose-response was found not to exist. Prior to chemotherapy, six patient groups each received a single intravenous dose of batanopride ranging from 0.2 to 6.0 mg/kg whereas a seventh group received methyl-prednisolone 250 mg intravenously. Chemotherapy-náive cancer patients scheduled to receive moderately emeto-genic chemotherapy were eligible. Primary treatment outcomes that were recorded and analyzed included the number of episodes of emesis, the time to the first episode of emesis as well as the frequency and severity of nausea. Two hundred and eight patients accrued between April 1989 and February 1990 were evaluable for response. A significant dose-response effect for complete protection from emesis was not seen over the first 24 hours after chemotherapy (p = 0.102). However, a linear dose-response effect for time to first emesis was evident in a multivariate analysis (p = 0.029). While the highest batanopride dose group was associated with a higher complete protection rate (CPR) than the control group, this group also exhibited a higher incidence of diarrhea (p = 0.013), hypotension, and electrocardiographic abnormalities. We conclude that batanopride is associated with significant side effects at doses that may be otherwise effective in this patient population. This trial design using multiple arms of different doses and a control arm is useful in validating efficacy data of new antiemetic agents derived from early Phase I trials.

antimetic, batanopride, chemotherapy-induced emesis, clinical trial, moderately-emetogenic chemotherapy, 5-hydroxytryptamine receptor antagonist


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