title: Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV).
abstract: OBJECTIVE
  Preventing chemotherapy-induced nausea and vomiting (CINV) is integral to treatment success in patients with cancer. This analysis was undertaken to assess the relative efficacy and safety of palonosetron versus older 5HT3 RAs in preventing CINV associated with moderately or highly emetogenic chemotherapy.
  
  
  METHODS
  Patient-level data from four randomized, double-blind, phase III trials comparing palonosetron 0.25 or 0.75 mg with ondansetron 32 mg, dolasetron 100 mg, or granisetron 40 μg/kg were analyzed. Endpoints included complete response (CR: no emesis and no rescue antiemetics) in the acute (0-24 h), delayed (>24-120 h), and overall (0-120 h) postchemotherapy periods (primary), complete control (CC: no emesis, no rescue antiemetics, and no more than mild nausea), number of emetic episodes, and nausea severity.
  
  
  RESULTS
  CR rates were significantly higher for palonosetron (n = 1,787) versus older 5HT3 RAs (n = 1,175) in the delayed (57 vs 45 %, P < 0.0001) and overall periods (51 vs 40 %, P < 0.0001); odds ratios (95 % CI) in the acute, delayed, and overall periods were 1.15 (0.98-1.34), 1.62 (1.40-1.88), and 1.56 (1.34-1.81), respectively. Significant differences in CC rates and nausea severity were observed for the delayed and overall periods and in emetic episodes for all three periods. The incidence of treatment-related adverse events was similar with palonosetron (0.25 mg, 20.0 %; 0.75 mg, 26.5 %) and older 5HT3 RAs (27.5 %).
  
  
  CONCLUSIONS
  Palonosetron is more effective than older 5HT3 RAs for controlling CINV in the delayed and overall postchemotherapy periods.
authors.affiliation: West Clinic, 100 North Humphreys Boulevard, Memphis, TN, 38120-2146, USA, lschwartzberg@westclinic.com.
authors.forename: Lee
authors.initials: L
authors.lastname: Schwartzberg
authors.forename: Sally Y
authors.initials: SY
authors.lastname: Barbour
authors.forename: Gary R
authors.initials: GR
authors.lastname: Morrow
authors.forename: Gianluca
authors.initials: G
authors.lastname: Ballinari
authors.forename: Michael D
authors.initials: MD
authors.lastname: Thorn
authors.forename: David
authors.initials: D
authors.lastname: Cox
mesh_terms: D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D017829:Granisetron / Q000008:administration & dosage; D006801:Humans; D007211:Indoles / Q000008:administration & dosage; D007546:Isoquinolines / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy*; D017294:Ondansetron / Q000008:administration & dosage; D000077924:Palonosetron; D011807:Quinolizines / Q000008:administration & dosage; D011812:Quinuclidines / Q000008:administration & dosage; D012702:Serotonin Antagonists / Q000008:administration & dosage; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D017829:Granisetron; D007211:Indoles; D007546:Isoquinolines; D017294:Ondansetron; D000077924:Palonosetron; D011807:Quinolizines; D011812:Quinuclidines; D012702:Serotonin Antagonists; C060344:dolasetron