Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity--an update

Support Care Cancer. 2005 Feb;13(2):80-4. doi: 10.1007/s00520-004-0718-y. Epub 2004 Dec 14.

Abstract

Development of effective antiemetic therapy depends upon an understanding of both the antiemetic agents and the emetogenic challenges these agents are designed to address. New potential antiemetic agents should be studied in an orderly manner, proceeding from phase I to phase II open-label trials and then to randomized double-blind phase III trials comparing new agents and regimens to best standard therapy. Use of placebos in place of antiemetic therapy against highly or moderately emetogenic chemotherapy is unacceptable. Nausea and vomiting should be evaluated separately and for both the acute and delayed periods. Defining the emetogenicity of new antineoplastic agents is a challenge, since such data are often not reliably recorded during early drug development. A four-level classification system is proposed for emetogenicity of intravenous antineoplastic agents. A separate four-level classification system for emetogenicity of oral antineoplastic agents, which are often given over an extended period of time, is also proposed.

Publication types

  • Review

MeSH terms

  • Antiemetics / classification
  • Antiemetics / therapeutic use*
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / classification
  • Clinical Trials as Topic / methods*
  • Humans
  • Nausea / chemically induced
  • Nausea / classification
  • Nausea / prevention & control*
  • Vomiting / chemically induced
  • Vomiting / classification
  • Vomiting / prevention & control*

Substances

  • Antiemetics
  • Antineoplastic Agents