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A double-blind, randomised, crossover comparison of granisetron and ondansetron in 5-day fractionated chemotherapy: Assessment of efficacy, safety and patient preference

https://doi.org/10.1016/0959-8049(94)90461-8Get rights and content

Abstract

We report the first double-blind, randomised, crossover study comparing granisetron and ondansetron as anti-emetics in cancer chemotherapy. Patients receiving two cycles of identical chemotherapy fractionated over 5 days were given either granisetron (3 mg/day) or ondansetron (24 mg/day) on each day of chemotherapy, using a double-dummy technique to preserve study blindness. Patients then crossed over to the other therapy. 309 patients (237 male) completed the crossover: 260 received cisplatin (mean dose 19.2 mg/m2/day) and 49 received ifosfamide (mean dose 1415 mg/m2/day). Primary efficacy variables were prospectively defined as complete response (no vomiting and mild or absent nausea) over 5 days, and patient preference. Both agents achieved good control of emetic symptoms with 5-day complete response rates of 44.0% on granisetron and 39.8% on ondansetron [95% confidence interval (CI) for odds ratio 0.8, 1.9]. Complete response rates were very similar in patients receiving either cisplatin (40.8% granisetron, 37.6% ondansetron) or ifosfamide (61.2% granisetron, 51.0% ondansetron). There was a statistically significant difference in patient preference in favour of granisetron, 105 patients preferred granisetron, 79 preferred ondansetron, 121 had no preference (P = 0.048: 95% CI for odds ratio 1.00, 1.84). Single daily doses of granisetron (3 mg/day) appeared similarly effective and well tolerated to three daily doses of ondansetron (8 mg three times daily) in prevention of emesis induced by 5-day fractionated chemotherapy, however, significantly more patients preferred granisetron.

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The Granisetron Study Group comprises Dr T. Andre, Paris, France; Dr P. Balmes, Nîmes, France; Dr S Block, Valenciennes, France; Dr P Bouffette, Neuilly-sur-Seine, France; Dr L. Cals, La Garde-Toulon, France; Dr J. Clavreul, Saint Etienne, France; Dr T. Conroy, Vandoeuvre les Nancy, France; Dr M. Crestin, Thionville, France; Dr D. Dearnaley, Sutton, U.K.; Dr R. Despax, Toulouse, France; Prof. Dr V. Diehl, Köln, Germany; Prof. G. Falkson, Pretoria, South Africa; Dr J.-P. Fombeur, Paris, France; Dr med R. Fuchs, Eschweiler, Germany; Dr med H. Fülle, Berlin 15, Germany; Prof. J.-C. Guerin, Lyon, France; Dr P. Harper, London, U.K.; Dr med J. Hartlapp, Bonn, Germany; Dr J.-F. Heron, Caen, France; Dr J.-P. Jacquin, Saint Etienne, France; Dr med D. Kamanabrou, Münster, Germany; Dr H.J. Keizer, Leiden, The Netherlands; Dr med H.J. König, Erlangen, Germany; Dr F. Larra, Dr P. Maillart, Angers, France; Prof. Dr med H. Ludwig, Wien, Austria; Dr P.H.M. de Mulder, Nijmegen, The Netherlands; Dr H. Naman, Cannes la Bocca, France; Dr G. Netter-Pinon, Reims, France; Prof. F. Oberling, Strasbourg, France; Prof. R. Plagne, Clermont-Ferrand, France; Dr med H. Riess, Berlin 20, Germany; Dr A. Riviere, Caen, France; Dr R. Samak, Nice, France; Dr med H. Samonigg, Mrs Dr A.K. Kasparek, Graz, Austria; Prof. S. Schraub, Besançon, France; Dr J. Schuller, Wien, Austria; Prof. Dr med S. Seeber, Essen, Germany; Prof. J.J. Sotto, Grenoble, France; Prof. Dr med H. Wagner, Weiden, Germany; Dr med J. Weiss, Regensburg, Germany; Prof. Dr med M. Westerhausen, Duisberg, Germany; Dr D. Zylberait, Compiegne, France.

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