Efficacy and safety of oral palonosetron compared with IV palonosetron administered with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with solid tumors receiving cisplatin-based highly emetogenic chemotherapy (HEC)

Meinolf Karthaus, Csőszi Tibor, Vito Lorusso, Rajender Singh-Arora, Alexander Filippov, Giada Rizzi, Maria Elisa Borroni, Giorgia Rossi, Steven M. Grunberg

Research output: Contribution to journalArticle

Abstract

Purpose: This study aims to compare the efficacy and safety of oral palonosetron with intravenous (IV) palonosetron for the prevention of cisplatin-related chemotherapy-induced nausea and vomiting (CINV). Methods: A multinational, randomized, double-blind study enrolling adult chemotherapy-naive patients with malignant solid tumors scheduled to receive cisplatin-based highly emetogenic chemotherapy (HEC). Patients received oral palonosetron (0.50 mg) or IV palonosetron (0.25 mg), each with oral dexamethasone. The primary objective was to demonstrate non-inferiority in terms of patients with a complete response (CR, no emesis/no rescue medication) within the acute phase (0–24 h after chemotherapy administration). Results: Of the 743 patients randomized, 739 received study medications and 738 were included in the full analysis set. The CR rate in the acute phase was high for both groups (oral 89.4 %; IV 86.2 %). As this difference in proportions (stratum-adjusted Cochran-Mantel-Haenszel method) was 3.21 % (99 % confidence interval (CI) −2.74 to 9.17 %), non-inferiority was demonstrated (since the lower limit of the 99 % CI was closer to zero than the predefined margin of 15 %). Treatment-emergent adverse events (TEAEs) related to the study drug were rare (oral 3.2 %; IV 6.5 %). No TEAEs related to study drug leading to discontinuation were reported. Conclusion: Non-inferiority of oral versus IV palonosetron was demonstrated. The CR rate in the acute phase was >86 % in both patient groups. The safety profiles were comparable.

Original languageEnglish
Pages (from-to)2917-2923
Number of pages7
JournalSupportive Care in Cancer
Volume23
Issue number10
DOIs
Publication statusPublished - Oct 31 2015

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Keywords

  • Chemotherapy-induced nausea and vomiting (CINV)
  • Cisplatin
  • Highly emetogenic chemotherapy (HEC)
  • Palonosetron

ASJC Scopus subject areas

  • Oncology

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