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.
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.
Segal
Brahm H
BH
Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York 14263, USA. brahm.segal@roswellpark.org
Herbrecht
Raoul
R
Stevens
David A
DA
Ostrosky-Zeichner
Luis
L
Sobel
Jack
J
Viscoli
Claudio
C
Walsh
Thomas J
TJ
Maertens
Johan
J
Patterson
Thomas F
TF
Perfect
John R
JR
Dupont
Bertrand
B
Wingard
John R
JR
Calandra
Thierry
T
Kauffman
Carol A
CA
Graybill
John R
JR
Baden
Lindsey R
LR
Pappas
Peter G
PG
Bennett
John E
JE
Kontoyiannis
Dimitrios P
DP
Cordonnier
Catherine
C
Viviani
Maria Anna
MA
Bille
Jacques
J
Almyroudis
Nikolaos G
NG
Wheat
L Joseph
LJ
Graninger
Wolfgang
W
Bow
Eric J
EJ
Holland
Steven M
SM
Kullberg
Bart-Jan
BJ
Dismukes
William E
WE
De Pauw
Ben E
BE
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
D000935:Antifungal Agents