title: Single-dose palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with aggressive non-Hodgkin's lymphoma receiving moderately emetogenic chemotherapy containing steroids: results of a phase II study from the Gruppo Italiano per lo Studio dei Linfomi (GISL).
abstract: OBJECTIVE
  The control of nausea and vomiting induced by chemotherapy is paramount for overall treatment success in cancer patients. Antiemetic therapy during chemotherapy in lymphoma patients generally consists of anti-serotoninergic drugs and dexamethasone. The aim of this trial was to evaluate the efficacy of a single dose of palonosetron, a second-generation serotonin type 3 (5-HT(3)) receptor antagonist, in patients with aggressive non-Hodgkin's lymphoma receiving moderately emetogenic chemotherapy (MEC) containing steroids.
  
  
  METHODS
  Patients received a single intravenous bolus of palonosetron (0.25 mg) before administration of chemotherapy. Complete response (CR) defined as no vomiting and no rescue therapy during overall phase (0-120 h) was the primary endpoint. Complete control (CC) defined as CR and only mild nausea was a secondary endpoint.
  
  
  RESULTS
  Eighty-six evaluable patients entered in the study. A CR was observed in 74 patients (86.0%) during the overall phase; the CR during the acute (0-24 h) and delayed (24-120 h) phases was 90.7% and 88.4%, respectively. CC was 89.5% during the acute and 84.9% during the delayed phase; the overall CC was 82.6%.
  
  
  CONCLUSIONS
  This was the first trial, which demonstrated the efficacy of a single dose of palonosetron in control CINV in patients with aggressive non-Hodgkin's lymphoma receiving MEC regimen containing steroids.
authors.affiliation: UO di Ematologia e Trapianto di Cellule Staminali, Ospedale Vito Fazzi, Piazza Filippo Muratore, 73100 Lecce, Italy. direnzo.ematolecce@libero.it
authors.forename: Nicola
authors.initials: N
authors.lastname: Di Renzo
authors.forename: Antonella
authors.initials: A
authors.lastname: Montanini
authors.forename: Donato
authors.initials: D
authors.lastname: Mannina
authors.forename: Alessandra
authors.initials: A
authors.lastname: Dondi
authors.forename: Stefania
authors.initials: S
authors.lastname: Muci
authors.forename: Salvatrice
authors.initials: S
authors.lastname: Mancuso
authors.forename: M Rosaria
authors.initials: MR
authors.lastname: De Paolis
authors.forename: Caterina
authors.initials: C
authors.lastname: Plati
authors.forename: Caterina
authors.initials: C
authors.lastname: Stelitano
authors.forename: Catia
authors.initials: C
authors.lastname: Patti
authors.forename: Attilio
authors.initials: A
authors.lastname: Olivieri
authors.forename: Eliana
authors.initials: E
authors.lastname: Liardo
authors.forename: Gabriele
authors.initials: G
authors.lastname: Buda
authors.forename: Renato
authors.initials: R
authors.lastname: Cantaffa
authors.forename: Massimo
authors.initials: M
authors.lastname: Federico
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D000077924:Palonosetron; D011446:Prospective Studies; D011812:Quinuclidines / Q000627:therapeutic use*; D058831:Serotonin 5-HT3 Receptor Antagonists / Q000627:therapeutic use; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000932:Antiemetics; D005938:Glucocorticoids; D007546:Isoquinolines; D011812:Quinuclidines; D058831:Serotonin 5-HT3 Receptor Antagonists; D000077924:Palonosetron; D003907:Dexamethasone