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 journalArticlepeer-review


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
Issue number10
Publication statusPublished - Oct 2013


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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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