title: Palonosetron versus older 5-HT3 receptor antagonists for nausea prevention in patients receiving chemotherapy: a multistudy analysis.
abstract: No clinical standard currently exists for the optimal management of nausea induced by emetogenic chemotherapy, 7particularly delayed nausea.
  
  
  
  To compare the effcacy and safety of palonosetron with older 5-HT3 receptor antagonists (RAs) in preventing chemotherapy-induced nausea.
  
  
  
  Data were pooled from 4 similarly designed multicenter, randomized, double-blind, clinical trials that compared single intravenous doses of palonosetron 0.25 mg or 0.75 mg with ondansetron 32 mg, dolasetron 100 mg, or granisetron 40 μg/kg, administered 30 minutes before moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). Pooled data within each chemotherapy category (MEC: n = 1,132; HEC: n = 1,781) were analyzed by a logistic regression model. Nausea endpoints were complete control rates (ie, no more than mild nausea, no vomiting, and no rescue medication), nausea-free rates, nausea severity, and requirement for rescue antiemetic/antinausea medication over 5 days following chemotherapy. Pooled safety data were summarized descriptively.
  
  
  
  Numerically more palonosetron-treated patients were nausea-free on each day, and fewer had moderate-severe nausea. Similarly, usage of rescue medication was less frequent among palonosetron-treated patients. Complete control rates for palonosetron and older 5-HT3 RAs in the acute phase were 66% vs 63%, 52% vs 42% in the delayed phase (24-120 hours), and 46% vs 37% in the overall phase. The incidence of adverse events was similar for palonosetron and older 5-HT3 RAs.
  
  
  
  This post hoc analysis summarized data for palonosetron and several other 5-HT3 RAs but was not powered for statistical comparisons between individual agents. Because nausea is inherently subjective, the reliability of assessments of some aspects (eg, severity) may be infuenced by interindividual variability.
  
  
  
  Palonosetron may be more effective than older 5-HT3 RAs in preventing nausea, with comparable tolerability.
  
  
  
  Dr Schwartzberg is a consultant to and Dr Cox an employee at Esai. Mr Ballinari is a member of staff at and Dr Thorn consults for Helsinn Healthcare SA. Funding to support this study and the preparation of this manuscript was provided by Eisai Inc.
authors.affiliation: University of Rochester School of Medicine and Dentistry, Rochester, New York, USA. Gary_Morrow@urmc.rochester.edu.
authors.forename: Gary R
authors.initials: GR
authors.lastname: Morrow
authors.affiliation: West Clinic, Memphis, Tennessee, USA.
authors.forename: Lee
authors.initials: L
authors.lastname: Schwartzberg
authors.affiliation: Department of Pharmacy, Duke University Medical Center, Durham, North Carolina, USA.
authors.forename: Sally Y
authors.initials: SY
authors.lastname: Barbour
authors.affiliation: Helsinn Healthcare SA, Lugano, Switzerland.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Ballinari
authors.affiliation: Statistics Resources Inc, Chapel Hill, North Carolina, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Thorn
authors.affiliation: Eisai Inc, Woodcliff, New Jersey, USA.
authors.forename: David
authors.initials: D
authors.lastname: Cox
references.citation: Gan To Kagaku Ryoho. 2012 Aug;39(8):1215-9
references.pmid: 22902445
references.citation: Eur J Pharmacol. 2012 Aug 15;689(1-3):25-30
references.pmid: 22683863
references.citation: Cancer Invest. 2000;18(2):163-73
references.pmid: 10705879
references.citation: J Clin Oncol. 1999 Sep;17(9):2971-94
references.pmid: 10561376
references.citation: Support Care Cancer. 2014 Feb;22(2):469-77
references.pmid: 24141698
references.citation: Toxicology. 2000 Nov 16;153(1-3):189-201
references.pmid: 11090957
references.citation: Eur J Cancer. 2003 May;39(8):1074-80
references.pmid: 12736106
references.citation: Cancer. 2003 Jun 1;97(11):2880-6
references.pmid: 12767103
references.citation: Ann Oncol. 2003 Oct;14(10):1570-7
references.pmid: 14504060
references.citation: Cancer. 2003 Dec 1;98(11):2473-82
references.pmid: 14635083
references.citation: Expert Opin Pharmacother. 2003 Dec;4(12):2297-303
references.pmid: 14640928
references.citation: J Clin Pharmacol. 2004 May;44(5):520-31
references.pmid: 15102873
references.citation: Cancer. 2004 May 15;100(10):2261-8
references.pmid: 15139073
references.citation: Lancet Oncol. 2005 Oct;6(10):765-72
references.pmid: 16198982
references.citation: Ann Oncol. 2006 Sep;17(9):1441-9
references.pmid: 16766588
references.citation: N Engl J Med. 2008 Jun 5;358(23):2482-94
references.pmid: 18525044
references.citation: Anesth Analg. 2008 Aug;107(2):469-78
references.pmid: 18633025
references.citation: Anesthesiology. 2008 Aug;109(2):206-12
references.pmid: 18648229
references.citation: Lancet Oncol. 2009 Feb;10(2):115-24
references.pmid: 19135415
references.citation: Eur J Pharmacol. 2010 Jan 25;626(2-3):193-9
references.pmid: 19836386
references.citation: Support Care Cancer. 2010 Jul;18(7):869-76
references.pmid: 19701781
references.citation: Ann Oncol. 2010 May;21 Suppl 5:v232-43
references.pmid: 20555089
references.citation: J Pharmacol Exp Ther. 2010 Nov;335(2):362-8
references.pmid: 20724484
references.citation: Support Care Cancer. 2011 Mar;19 Suppl 1:S43-7
references.pmid: 20972805
references.citation: Support Care Cancer. 2011 Jun;19(6):823-32
references.pmid: 20495832
references.citation: J Clin Oncol. 2011 Nov 1;29(31):4189-98
references.pmid: 21947834
references.citation: Eur J Pharmacol. 2012 Jun 5;684(1-3):1-7
references.pmid: 22425650
references.citation: Support Care Cancer. 2012 Jul;20(7):1435-9
references.pmid: 21773677
references.citation: Support Care Cancer. 2012 Oct;20(10):2343-7
references.pmid: 22170340