Prevention of cisplatin-induced emesis: A double-blind multicenter randomized crossover study comparing ondansetron and ondansetron plus dexamethasone

Fausto Roila, Maurizio Tonato, Francesco Cognetti, Enrico Cortesi, Giuseppe Favalli, Maurizio Marangolo, Dino Amadori, Maria Angela Bella, Vattilio Gramazio, Donatella Donati, Enzo Ballatori, Albano Del Favero

Research output: Contribution to journalArticle

Abstract

Ondansetron (OND) is a new 5-HT3 receptor antagonist that gives complete protection from emesis/ nausea in approximately 50% of cisplatin (CDDP)-treated patients. To evaluate if dexamethasone (DEX) added to OND increases antiemetic efficacy, we carried out a double-blind randomized crossover study to compare the antiemetic activity of OND with OND plus DEX. One hundred two chemotherapy-naive patients (44 women and 58 men) scheduled to receive CDDP chemotherapy at doses ≥ 50 mg/m2 entered the study. Eighty-nine patients completed both cycles with the following results: complete protection from emesis/ nausea was obtained in 57/59 patients (64.0%/66.3%) with OND and in 81/79 (91.0%/88.8%) with OND plus DEX (P = .0005/P = .0021). At the end of the study, 53% of the patients expressed a treatment preference, and of these, 74% chose OND plus DEX compared with 26% who preferred OND alone, a statistically significant difference (P <.003). Side effects were very mild and not significantly different between the two treatments. We conclude that OND plus DEX is more efficacious than OND in protecting patients from CDDP-induced emesis and nausea.

Original languageEnglish
Pages (from-to)675-678
Number of pages4
JournalJournal of Clinical Oncology
Volume9
Issue number4
Publication statusPublished - 1991

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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    Roila, F., Tonato, M., Cognetti, F., Cortesi, E., Favalli, G., Marangolo, M., Amadori, D., Bella, M. A., Gramazio, V., Donati, D., Ballatori, E., & Favero, A. D. (1991). Prevention of cisplatin-induced emesis: A double-blind multicenter randomized crossover study comparing ondansetron and ondansetron plus dexamethasone. Journal of Clinical Oncology, 9(4), 675-678.