An open multicentre comparative study of the efficacy, safety and tolerance of fluconazole and itraconazole in the treatment of cancer patients with oropharyngeal candidiasis.

Author(s): Oude Lashof AM, De Bock R, Herbrecht R, de Pauw BE, Krcmery V, Aoun M, Akova M, Cohen J, Siffnerova H, Egyed M, Ellis M, Marinus A, Sylvester R, Kullberg BJ, EORTC Invasive Fungal Infections Group

Affiliation(s): Nijmegen University Medical Center, St Radboud and Nijmegen University, Center for Infectious Diseases, Nijmegen, The Netherlands.

Publication date & source: 2004-06, Eur J Cancer., 40(9):1314-9.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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.