title: Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria.
abstract: Invasive fungal diseases (IFDs) have become major causes of morbidity and mortality among highly immunocompromised patients. Authoritative consensus criteria to diagnose IFD have been useful in establishing eligibility criteria for antifungal trials. There is an important need for generation of consensus definitions of outcomes of IFD that will form a standard for evaluating treatment success and failure in clinical trials. Therefore, an expert international panel consisting of the Mycoses Study Group and the European Organization for Research and Treatment of Cancer was convened to propose guidelines for assessing treatment responses in clinical trials of IFDs and for defining study outcomes. Major fungal diseases that are discussed include invasive disease due to Candida species, Aspergillus species and other molds, Cryptococcus neoformans, Histoplasma capsulatum, and Coccidioides immitis. We also discuss potential pitfalls in assessing outcome, such as conflicting clinical, radiological, and/or mycological data and gaps in knowledge.
authors.affiliation: Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York 14263, USA. brahm.segal@roswellpark.org
authors.forename: Brahm H
authors.initials: BH
authors.lastname: Segal
authors.forename: Raoul
authors.initials: R
authors.lastname: Herbrecht
authors.forename: David A
authors.initials: DA
authors.lastname: Stevens
authors.forename: Luis
authors.initials: L
authors.lastname: Ostrosky-Zeichner
authors.forename: Jack
authors.initials: J
authors.lastname: Sobel
authors.forename: Claudio
authors.initials: C
authors.lastname: Viscoli
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Walsh
authors.forename: Johan
authors.initials: J
authors.lastname: Maertens
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Patterson
authors.forename: John R
authors.initials: JR
authors.lastname: Perfect
authors.forename: Bertrand
authors.initials: B
authors.lastname: Dupont
authors.forename: John R
authors.initials: JR
authors.lastname: Wingard
authors.forename: Thierry
authors.initials: T
authors.lastname: Calandra
authors.forename: Carol A
authors.initials: CA
authors.lastname: Kauffman
authors.forename: John R
authors.initials: JR
authors.lastname: Graybill
authors.forename: Lindsey R
authors.initials: LR
authors.lastname: Baden
authors.forename: Peter G
authors.initials: PG
authors.lastname: Pappas
authors.forename: John E
authors.initials: JE
authors.lastname: Bennett
authors.forename: Dimitrios P
authors.initials: DP
authors.lastname: Kontoyiannis
authors.forename: Catherine
authors.initials: C
authors.lastname: Cordonnier
authors.forename: Maria Anna
authors.initials: MA
authors.lastname: Viviani
authors.forename: Jacques
authors.initials: J
authors.lastname: Bille
authors.forename: Nikolaos G
authors.initials: NG
authors.lastname: Almyroudis
authors.forename: L Joseph
authors.initials: LJ
authors.lastname: Wheat
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Graninger
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Bow
authors.forename: Steven M
authors.initials: SM
authors.lastname: Holland
authors.forename: Bart-Jan
authors.initials: BJ
authors.lastname: Kullberg
authors.forename: William E
authors.initials: WE
authors.lastname: Dismukes
authors.forename: Ben E
authors.initials: BE
authors.lastname: De Pauw
mesh_terms: D000935:Antifungal Agents / Q000627:therapeutic use*; D001228:Aspergillosis / Q000188:drug therapy*; D035843:Biomedical Research / Q000592:standards*; D002177:Candidiasis / Q000188:drug therapy*; D003047:Coccidioidomycosis / Q000188:drug therapy*; D003453:Cryptococcosis / Q000188:drug therapy*; D006660:Histoplasmosis / Q000188:drug therapy*; D006801:Humans; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents