title: An open multicentre comparative study of the efficacy, safety and tolerance of fluconazole and itraconazole in the treatment of cancer patients with oropharyngeal candidiasis.
abstract: Oropharyngeal candidiasis is a frequent infection in cancer patients who receive cytotoxic drugs. In this study, the efficacy, safety and tolerance of fluconazole and itraconazole were compared in non-neutropenic cancer patients with oropharyngeal candidiasis. Of 279 patients who were randomised between the two treatment groups, 252 patients were considered to be eligible (126 in each group). The clinical cure rate was 74% for fluconazole and 62% for itraconazole (P=0.04, 95% Confidence Interval (CI): 0.5-23.3%). The mycological cure rate was 80% for fluconazole and 68% for itraconazole (P=0.03, 95% CI: 1.2-22.6%). The safety and tolerance profile of both drugs were comparable. This study has shown that in patients with cancer and oropharyngeal candidiasis, fluconazole has a significantly better clinical and mycological cure rate compared with itraconazole.
authors.affiliation: Nijmegen University Medical Center, St Radboud and Nijmegen University, Center for Infectious Diseases, Nijmegen, The Netherlands.
authors.forename: A M L
authors.initials: AM
authors.lastname: Oude Lashof
authors.forename: R
authors.initials: R
authors.lastname: De Bock
authors.forename: R
authors.initials: R
authors.lastname: Herbrecht
authors.forename: B E
authors.initials: BE
authors.lastname: de Pauw
authors.forename: V
authors.initials: V
authors.lastname: Krcmery
authors.forename: M
authors.initials: M
authors.lastname: Aoun
authors.forename: M
authors.initials: M
authors.lastname: Akova
authors.forename: J
authors.initials: J
authors.lastname: Cohen
authors.forename: H
authors.initials: H
authors.lastname: Siffnerová
authors.forename: M
authors.initials: M
authors.lastname: Egyed
authors.forename: M
authors.initials: M
authors.lastname: Ellis
authors.forename: A
authors.initials: A
authors.lastname: Marinus
authors.forename: R
authors.initials: R
authors.lastname: Sylvester
authors.forename: B J
authors.initials: BJ
authors.lastname: Kullberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D002176:Candida albicans; D041221:Candida glabrata; D002180:Candidiasis, Oral / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D015725:Fluconazole / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D016867:Immunocompromised Host; D017964:Itraconazole / Q000009:adverse effects / Q000627:therapeutic use; D008099:Liver / Q000503:physiopathology; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000382:microbiology* / Q000401:mortality / Q000503:physiopathology
chemical_list: D000935:Antifungal Agents; D017964:Itraconazole; D015725:Fluconazole