title: 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).
authors.affiliation: Compassionate Cancer Care Medical Group , Riverside, CA , USA.
authors.forename: Brian S
authors.initials: BS
authors.lastname: Choi
authors.forename: Gabriela P
authors.initials: GP
authors.lastname: Borsaru
authors.forename: Gianluca
authors.initials: G
authors.lastname: Ballinari
authors.forename: Daniel
authors.initials: D
authors.lastname: Voisin
authors.forename: Nicola
authors.initials: N
authors.lastname: Di Renzo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D018890:Chemoprevention; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008228:Lymphoma, Non-Hodgkin / Q000150:complications* / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced* / Q000517:prevention & control*; D000077924:Palonosetron; D011812:Quinuclidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced* / Q000517:prevention & control*
chemical_list: D007546:Isoquinolines; D011812:Quinuclidines; D012702:Serotonin Antagonists; D000077924:Palonosetron