title: Daily palonosetron is superior to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting in patients with acute myelogenous leukemia.
abstract: BACKGROUND
  Nausea and vomiting in patients with acute myelogenous leukemia (AML) can be from various causes, including the use of high-dose cytarabine.
  
  
  METHODS
  The authors compared 2 schedules of palonosetron versus ondansetron in the treatment of chemotherapy-induced nausea and vomiting (CINV) in patients with AML receiving high-dose cytarabine. Patients were randomized to: 1) ondansetron, 8 mg intravenously (IV), followed by 24 mg continuous infusion 30 minutes before high-dose cytarabine and until 12 hours after the high-dose cytarabine infusion ended; 2) palonosetron, 0.25 mg IV 30 minutes before chemotherapy, daily from Day 1 of high-dose cytarabine up to Day 5; or 3) palonosetron, 0.25 mg IV 30 minutes before high-dose cytarabine on Days 1, 3, and 5.
  
  
  RESULTS
  Forty-seven patients on ondansetron and 48 patients on each of the palonosetron arms were evaluable for efficacy. Patients in the palonosetron arms achieved higher complete response rates (no emetic episodes plus no rescue medication), but the difference was not statistically significant (ondansetron, 21%; palonosetron on Days 1-5, 31%; palonosetron on Days 1, 3, and 5, 35%; P = .32). Greater than 77% of patients in each arm were free of nausea on Day 1; however, on Days 2 through 5, the proportion of patients without nausea declined similarly in all 3 groups. On Days 6 and 7, significantly more patients receiving palonosetron on Days 1 to 5 were free of nausea (P = .001 and P = .0247, respectively).
  
  
  CONCLUSIONS
  The daily assessments of emesis did not show significant differences between the study arms. Patients receiving palonosetron on Days 1 to 5 had significantly less severe nausea and experienced significantly less impact of CINV on daily activities on Days 6 and 7.
authors.affiliation: Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA. gmattiuz@mdanderson.org
authors.forename: Gloria N
authors.initials: GN
authors.lastname: Mattiuzzi
authors.forename: Jorge E
authors.initials: JE
authors.lastname: Cortes
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Blamble
authors.forename: B Nebiyou
authors.initials: BN
authors.lastname: Bekele
authors.forename: Lianchun
authors.initials: L
authors.lastname: Xiao
authors.forename: Maria
authors.initials: M
authors.lastname: Cabanillas
authors.forename: Gautam
authors.initials: G
authors.lastname: Borthakur
authors.forename: Susan
authors.initials: S
authors.lastname: O'Brien
authors.forename: Hagop
authors.initials: H
authors.lastname: Kantarjian
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D003561:Cytarabine / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000517:prevention & control; D017294:Ondansetron / Q000009:adverse effects / Q000627:therapeutic use*; D000077924:Palonosetron; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D014839:Vomiting / Q000517:prevention & control
chemical_list: D000932:Antiemetics; D007546:Isoquinolines; D011812:Quinuclidines; D012702:Serotonin Antagonists; D003561:Cytarabine; D017294:Ondansetron; D000077924:Palonosetron