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

被引:388
作者
Segal, Brahm H. [1 ]
Herbrecht, Raoul [10 ,23 ]
Stevens, David A. [9 ]
Ostrosky-Zeichner, Luis [4 ]
Sobel, Jack [7 ]
Viscoli, Claudio [30 ,31 ]
Walsh, Thomas J. [12 ]
Maertens, Johan [32 ]
Patterson, Thomas F. [5 ]
Perfect, John R. [2 ]
Dupont, Bertrand [24 ]
Wingard, John R. [8 ]
Calandra, Thierry [21 ,22 ]
Kauffman, Carol A. [6 ]
Graybill, John R. [5 ]
Baden, Lindsey R. [15 ]
Pappas, Peter G. [11 ]
Bennett, John E. [13 ]
Kontoyiannis, Dimitrios P. [3 ]
Cordonnier, Catherine [25 ,26 ]
Viviani, Maria Anna [29 ]
Bille, Jacques [20 ]
Almyroudis, Nikolaos G. [1 ]
Wheat, L. Joseph [14 ]
Graninger, Wolfgang [27 ,28 ]
Bow, Eric J. [16 ]
Holland, Steven M. [13 ]
Kullberg, Bart-Jan [18 ,19 ]
Dismukes, William E. [11 ]
De Pauw, Ben E. [17 ]
机构
[1] Roswell Pk Canc Inst, Dept Med, Buffalo, NY 14263 USA
[2] Duke Univ, Med Ctr, Durham, NC USA
[3] Univ Texas MD Anderson Canc Ctr, San Antonio, TX USA
[4] Univ Texas Hlth Sci Ctr Houston, San Antonio, TX USA
[5] Univ Texas Hlth Sci Ctr San Antonio, Dept Med, San Antonio, TX 78229 USA
[6] Univ Michigan, Ann Arbor, MI 48109 USA
[7] Wayne State Univ, Sch Med, Detroit, MI USA
[8] Univ Florida, Coll Med, Gainesville, FL USA
[9] Santa Clara Valley Med Ctr, San Jose, CA 95128 USA
[10] Stanford Univ, Sch Med, Stanford, CA 94305 USA
[11] Univ Alabama Birmingham, Dept Med, Birmingham, AL 35294 USA
[12] NCI, Pediat Oncol Branch, Bethesda, MD 20892 USA
[13] NIAID, Lab Clin Infect Dis, NIH, Bethesda, MD 20892 USA
[14] MiraVista Diagnost MiraBella Technol, Indianapolis, IN USA
[15] Harvard Univ, Sch Med, Brigham & Womens Hosp, Dana Farber Canc Inst,Div Infect Dis, Cambridge, MA 02138 USA
[16] Univ Manitoba, Winnipeg, MB, Canada
[17] Univ Med Ctr St Raboud, Nijmegen, Netherlands
[18] Univ Nijmegen, Med Ctr, Dept Med, Nijmegen, Netherlands
[19] Radboud Univ Nijmegen, Med Ctr, NL-6525 ED Nijmegen, Netherlands
[20] Univ Lausanne Hosp, Inst Microbiol, Lausanne, Switzerland
[21] CHU Vaudois, Dept Med, Infect Dis Serv, CH-1011 Lausanne, Switzerland
[22] Univ Lausanne, Lausanne, Switzerland
[23] Hosp Hautepierre, Dept Hematol & Oncol, Strasbourg, France
[24] Hop Necker Enfants Malad, Paris, France
[25] Hop Henri Mondor, APHP, F-94010 Creteil, France
[26] Univ Paris 12, Creteil, France
[27] Med Univ Vienna, Vienna, Austria
[28] Univ Hosp Vienna, Div Infect Dis, Vienna, Austria
[29] Univ Milan, Dept Publ Hlth Microbiol & Virol, Sect Publ Hlth, Milan, Italy
[30] Univ Genoa, Genoa, Italy
[31] San Martino Univ Hosp, Div Infect Dis, Genoa, Italy
[32] Univ Hosp Gasthuisberg, Dept Hematol, Acute Leukemia & Hematopoiet Stem Cell Transplant, B-3000 Louvain, Belgium
关键词
D O I
10.1086/590566
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 [免疫学];
摘要
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.
引用
收藏
页码:674 / 683
页数:10
相关论文
共 78 条
[1]
ALBELDA SM, 1985, AM REV RESPIR DIS, V131, P115
[2]
Issues related to the design and interpretation of clinical trials of salvage therapy for invasive mold infection [J].
Almyroudis, Nikolaos G. ;
Kontoyiannis, Dimitrios P. ;
Sepkowitz, Kent A. ;
DePauw, Ben E. ;
Walsh, Thomas J. ;
Segal, Brahm H. .
CLINICAL INFECTIOUS DISEASES, 2006, 43 (11) :1449-1455
[4]
Infusion-related toxicity of three different amphotericin B formulations and its relation to cytokine plasma levels [J].
Arning, M ;
Kliche, KO ;
HeerSonderhoff, AH ;
Wehmeier, A .
MYCOSES, 1995, 38 (11-12) :459-465
[5]
Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: An international consensus [J].
Ascioglu, S ;
Rex, JH ;
de Pauw, B ;
Bennett, JE ;
Bille, J ;
Crokaert, F ;
Denning, DW ;
Donnelly, JP ;
Edwards, JE ;
Erjavec, Z ;
Fiere, D ;
Lortholary, O ;
Maertens, J ;
Meis, JF ;
Patterson, TF ;
Ritter, J ;
Selleslag, D ;
Shah, PM ;
Stevens, DA ;
Walsh, TJ .
CLINICAL INFECTIOUS DISEASES, 2002, 34 (01) :7-14
[6]
Liposomal amphotericin B activates antifungal resistance with reduced toxicity by diverting Toll-like receptor signalling from TLR-2 to TLR-4 [J].
Bellocchio, S ;
Gaziano, R ;
Bozza, S ;
Rossi, G ;
Montagnoli, C ;
Perruccio, K ;
Calvitti, M ;
Pitzurra, L ;
Romani, L .
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 2005, 55 (02) :214-222
[7]
Forum report: Issues in the design of trials of drugs for the treatment of invasive aspergillosis [J].
Bennett, JE ;
Powers, J ;
de Pauw, B ;
Dismukes, W ;
Galgiani, J ;
Glauser, M ;
Herbrecht, R ;
Kauffman, C ;
Lee, J ;
Pappas, P ;
Rex, J ;
Verweij, P ;
Viscoli, C ;
Walsh, T .
CLINICAL INFECTIOUS DISEASES, 2003, 36 :S113-S116
[8]
Forum report: Issues in clinical trials of empirical antifungal therapy in treating febrile neutropenic patients [J].
Bennett, JE ;
Powers, J ;
Walsh, T ;
Viscoli, C ;
de Pauw, B ;
Dismukes, W ;
Galgiani, J ;
Glauser, M ;
Herbrecht, R ;
Kauffman, C ;
Lee, J ;
Pappas, P ;
Rex, J ;
Verweij, P .
CLINICAL INFECTIOUS DISEASES, 2003, 36 :S117-S122
[9]
Forum report: Issues in the evaluation of diagnostic tests, use of historical controls, and merits of the current multicenter collaborative groups [J].
Bennett, JE ;
Kauffman, C ;
Walsh, T ;
de Pauw, B ;
Dismukes, W ;
Galgiani, J ;
Glauser, M ;
Herbrecht, R ;
Lee, J ;
Pappas, P ;
Powers, J ;
Rex, J ;
Verweij, P ;
Viscoli, C .
CLINICAL INFECTIOUS DISEASES, 2003, 36 :S123-S127
[10]
Invasive aspergillosis in allogeneic stem cell transplant recipients: Increasing antigenemia is associated with progressive disease [J].
Boutboul, F ;
Alberti, C ;
Leblanc, T ;
Sulahian, A ;
Gluckman, E ;
Derouin, F ;
Ribaud, P .
CLINICAL INFECTIOUS DISEASES, 2002, 34 (07) :939-943