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

• Published in: Leukemia & lymphoma 2014-03, Vol.55 (3), p.544-550
• Main Authors: Choi, Brian S., Borsaru, Gabriela P., Ballinari, Gianluca, Voisin, Daniel, Di Renzo, Nicola
• Format: Article
• Language: English
• Subjects: 5-HT; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Chemoprevention; chemotherapy-induced nausea and vomiting; CINV; emetogenic chemotherapy; Humans; Isoquinolines - administration & dosage; Isoquinolines - adverse effects; Isoquinolines - therapeutic use; Lymphoma, Non-Hodgkin - complications; Lymphoma, Non-Hodgkin - drug therapy; Male; Middle Aged; Nausea - chemically induced; Nausea - prevention & control; Original; Palonosetron; Quinuclidines - administration & dosage; Quinuclidines - adverse effects; Quinuclidines - therapeutic use; Serotonin Antagonists - administration & dosage; Serotonin Antagonists - adverse effects; Serotonin Antagonists - therapeutic use; serotonin-type 3 receptor antagonist; Treatment Outcome; Vomiting - chemically induced; Vomiting - prevention & control
• ISSN: 1042-8194; 1029-2403
• DOI: 10.3109/10428194.2013.813498

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).