Multicenter phase IV study of palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with non-Hodgkin lymphomas undergoing repeated cycles of moderately emetogenic chemotherapy

Abstract

Antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with non-Hodgkin lymphoma (NHL) receiving moderately emetogenic chemotherapy (MEC) generally includes a serotonin-type 3 (5-HT₃) receptor antagonist (RA). The efficacy and safety of the second-generation 5-HT₃ RA, palonosetron, in patients with NHL receiving MEC was assessed. Patients received a single iv bolus injection of 0.25 mg palonosetron and chemotherapy on day 1 of the first chemotherapy cycle, and up to three further consecutive cycles. Eighty-eight patients were evaluable for efficacy and safety. The primary endpoint, the percentage of patients with a complete response in the overall phase (0–120 h after chemotherapy in each cycle), increased from 68.2% (cycle 1) to 80.5% (cycle 2), remaining high for the following cycles, and > 90% patients were emesis-free without using aprepitant during therapy. Across all cycles, 78.4% of patients experienced treatment-emergent adverse events, but only 8% related to study drug, confirming palonosetron's good safety profile (EudraCT Number: 2008-007827-14).

Keywords::

• Palonosetron
• emetogenic chemotherapy
• serotonin-type 3 receptor antagonist
• 5-HT₃ RA
• chemotherapy-induced nausea and vomiting
• CINV

Potential conflict of interest:

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This study was funded by Helsinn, 6915 Pambio-Noranco (Lugano), Switzerland. Medical writing support was provided by Dr. Anne Kinsella, Cancer Communications and Consultancy Ltd., Knutsford, Cheshire, UK, funded by Helsinn.