Original Article

You have full text access to this OnlineOpen article

Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist

Results of a Phase III, single-dose trial versus dolasetron

  1. Peter Eisenberg MD1,†,
  2. Jazmin Figueroa-Vadillo MD2,
  3. Rosalio Zamora MD3,
  4. Veena Charu MD4,
  5. Julio Hajdenberg MD5,
  6. Alan Cartmell MD6,
  7. Alberto Macciocchi MD7,‡,*,
  8. Steven Grunberg MD8

Article first published online: 16 OCT 2003

DOI: 10.1002/cncr.11817

Issue

Cancer

Cancer

Volume 98, Issue 11, pages 2473–2482, 1 December 2003

Additional Information

How to Cite

Eisenberg, P., Figueroa-Vadillo, J., Zamora, R., Charu, V., Hajdenberg, J., Cartmell, A., Macciocchi, A. and Grunberg, S. (2003), Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist. Cancer, 98: 2473–2482. doi: 10.1002/cncr.11817

Author Information

  1. 1

    California Cancer Care, Greenbrae, California

  2. 2

    Hospital General Mexico, Mexico City, Mexico

  3. 3

    Hospital Regional 1° de Octubre, Mexico City, Mexico

  4. 4

    Pacific Cancer Medical Center, Anaheim, California

  5. 5

    Pasco-Pinellas Cancer Center, Tarpon Springs, Florida

  6. 6

    Comprehensive Blood and Cancer Center, Bakersfield, California

  7. 7

    Helsinn Healthcare SA, Lugano, Switzerland

  8. 8

    Fletcher Allen Health Care, Burlington, Vermont

  1. †

    Dr. Eisenberg has participated in clinical trials and received consulting fees and honoraria from Helsinn Healthcare SA (Lugano, Switzerland), MGI Pharma (Bloomington, Minnesota), GlaxoSmithKline (Research Triangle Park, North Carolina), Merck (Whitehouse Station, New Jersey), Roche (Basel, Switzerland), and Aventis Pharmaceuticals (Bridgewater, New Jersey). Dr. Cartmell is a clinical investigator for MGI Pharma. Dr. Macciocchi is an employee of Helsinn Healthcare SA. Dr. Grunberg is a consultant to Helsinn Healthcare SA and has received honoraria from MGI Pharma.

  2. ‡

    Fax: (011) 41-91-993-21-22

*Helsinn Healthcare SA, P.O. Box 357, 6915 Pambio-Noranco (Lugano(, Switzerland

Publication History

  1. Issue published online: 17 NOV 2003
  2. Article first published online: 16 OCT 2003
  3. Manuscript Accepted: 1 SEP 2003
  4. Manuscript Revised: 11 AUG 2003
  5. Manuscript Received: 5 MAY 2003

Funded by

  • Helsinn Healthcare SA

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (174K)

REFERENCES

  • 1
    Balfour JA, Goa KL. Dolasetron: a review of its pharmacology and therapeutic potential in the management of nausea and vomiting induced by chemotherapy, radiotherapy or surgery. Drugs. 1997; 54: 273–298.
  • 2
    Hesketh PJ. Comparative review of 5-HT3 receptor antagonists in the treatment of acute chemotherapy-induced nausea and vomiting. Cancer Invest. 2000; 18: 163–173.
  • 3
    Koeller JM, Aapro MS, Gralla RJ, et al. Antiemetic guidelines: creating a more practical treatment approach. Support Care Cancer. 2002; 10: 519–522.
  • 4
    American Society of Health-System Pharmacists therapeutic guidelines on the pharmacologic management of nausea and vomiting in adult and pediatric patients receiving chemotherapy or radiation therapy or undergoing surgery. Am J Health Syst Pharm. 1999; 56: 729–764.
  • 5
    Gralla RJ, Osoba D, Kris MG, et al. Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. American Society of Clinical Oncology. J Clin Oncol. 1999; 17: 2971–2994.
  • 6
    Ettinger DS, Bierman PJ, Bradbury B, et al. The NCCN antiemesis clinical practice guidelines in oncology (Version 1. 2002) [monograph online]. Available from URL: http://www.nccn.org/physician_gls/index.html [accessed April 16, 2003].
  • 7
    Johnston D, Latreille J, Laberge F, et al. Preventing nausea and vomiting during days 2-7 following high dose cisplatin chemotherapy (HDCP). A study by the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) [abstract]. Proc Am Soc Clin Oncol. 1995; 14: 529.
  • 8
    Kaizer L, Warr D, Hoskins P, et al. Effect of schedule and maintenance on the antiemetic efficacy of ondansetron combined with dexamethasone in acute and delayed nausea and emesis in patients receiving moderately emetogenic chemotherapy: a Phase III trial by the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 1994; 12: 1050–1057.
  • 9
    Hesketh PJ. Potential role of the NK1 receptor antagonists in chemotherapy-induced nausea and vomiting. Support Care Cancer. 2001; 9: 350–354.
  • 10
    Wong EH, Clark R, Leung E, et al. The interaction of RS 25259-197, a potent and selective antagonist, with 5-HT3 receptors, in vitro. Br J Pharmacol. 1995; 114: 851–859.
  • 11
    Eisenberg P, MacKintosh FR, Ritch P, Cornett PA, Macciocchi A. Efficacy, safety and pharmacokinetics of palonosetron in patients receiving highly emetogeric, cisplatin-based chemotherapy: a dose-ranging, clinical study. Ann Oncol. In press.
  • 12
    Lindley CM, Hirsch JD, O'Neill CV, Transau MC, Gilbert CS, Osterhaus JT. Quality of life consequences of chemotherapy-induced emesis. Qual Life Res. 1992; 1: 331-340.
  • 13
    Miller RC, Galvan M, Gittos MW, van Giersbergen PL, Moser PC, Fozard JR. Pharmacological properties of dolasetron, a potent and selective antagonist at 5-HT3 receptors. Drug Dev Res. 1993; 28: 87–93.
    Direct Link:
  • 14
    Piraccini G, Stolz R, Tei M, Macciocchi A. Pharmacokinetic features of a novel 5-HT3-receptor antagonist: palonosetron (RS 25259-197) [abstract]. Proc Am Soc Clin Oncol. 2001; 20: 400a.
  • 15
    Aventis Pharmaceuticals. Anzemet (dolasetron mesylate injection) [package insert]. Bridgewater, NJ: Aventis, 2002.
  • 16
    GlaxoSmithKline. Zofran (ondansetron hydrochloride) injection [package insert]. Research Triangle Park, NC: GlaxoSmithKline, 2001.
  • 17
    Roche Laboratories. Kytril (granisetron hydrochloride) injection [package insert]. Nutley, NJ: Roche, 2000.
View Full Article (HTML) Get PDF (174K)