Palonosetron plus dexamethasone in highly emetogenic chemotherapy: Pooled data from two Phase III trials

Luigi Celio, Francesco Agustoni, Francesca Ricchini, Katia Dotti, Monica Niger, Filippo De Braud

Research output: Contribution to journalArticle

Abstract

Aim: Data from two randomized trials were pooled to further characterize the effectiveness of palonosetron combined with dexamethasone in the setting of highly emetogenic chemotherapy. Patients & methods: The analysis included 1411 patients who were randomized to receive palonosetron or ondansetron/granisetron intravenously on day 1 plus either 1-day or 3-day dexamethasone dosing. The primary end point was complete response (no vomiting and no rescue antiemetics over days 1-5) in cycle one. Data across the studies were analyzed by the Mantel-Haenszel method. Results: The vast majority of patients received either cisplatin (62%) or anthracycline plus cyclophosphamide (34%). The palonosetron regimen provided a 12 percentage-point improvement in the rate of overall complete response compared with the control regimen (49.2 vs 37.3%; odds ratio: 1.65; 95% CI: 1.33-2.04; p <0.0001). The frequency of no delayed nausea at all daily periods was consistently higher in the palonosetron group. Conclusion: The current analysis confirmed that palonosetron plus dexamethasone improved control of highly emetogenic chemotherapy-induced nausea and vomiting throughout 5 days postchemotherapy to a significantly greater extent than the combination including older 5-HT3 antagonists.

Original languageEnglish
Pages (from-to)1451-1458
Number of pages8
JournalFuture Oncology
Volume9
Issue number10
DOIs
Publication statusPublished - Oct 2013

Fingerprint

Dexamethasone
Drug Therapy
Nausea
Vomiting
Granisetron
Serotonin 5-HT3 Receptor Antagonists
Ondansetron
Antiemetics
Anthracyclines
Cyclophosphamide
Cisplatin
Odds Ratio
palonosetron

Keywords

  • chemotherapy-induced nausea and vomiting
  • dexamethasone
  • highly emetogenic chemotherapy
  • nausea
  • palonosetron
  • vomiting

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Palonosetron plus dexamethasone in highly emetogenic chemotherapy : Pooled data from two Phase III trials. / Celio, Luigi; Agustoni, Francesco; Ricchini, Francesca; Dotti, Katia; Niger, Monica; Braud, Filippo De.

In: Future Oncology, Vol. 9, No. 10, 10.2013, p. 1451-1458.

Research output: Contribution to journalArticle

Celio, Luigi ; Agustoni, Francesco ; Ricchini, Francesca ; Dotti, Katia ; Niger, Monica ; Braud, Filippo De. / Palonosetron plus dexamethasone in highly emetogenic chemotherapy : Pooled data from two Phase III trials. In: Future Oncology. 2013 ; Vol. 9, No. 10. pp. 1451-1458.
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