title: Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity--an update.
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.
authors.affiliation: University of Vermont, Burlington, Vermont 05401, USA. Steven.Grunberg@uvm.edu
authors.forename: Steven M
authors.initials: SM
authors.lastname: Grunberg
authors.forename: David
authors.initials: D
authors.lastname: Osoba
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Hesketh
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Gralla
authors.forename: Sussanne
authors.initials: S
authors.lastname: Borjeson
authors.forename: Bernardo L
authors.initials: BL
authors.lastname: Rapoport
authors.forename: Andreas
authors.initials: A
authors.lastname: du Bois
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tonato
mesh_terms: D000932:Antiemetics / Q000145:classification / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000145:classification; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D009325:Nausea / Q000139:chemically induced / Q000145:classification / Q000517:prevention & control*; D014839:Vomiting / Q000139:chemically induced / Q000145:classification / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents