A comparative study of the efficacy and safety of fluconazole oral suspension and amphotericin B oral suspension in cancer patients with mucositis.

Author(s): Lefebvre JL, Domenge C, Study Group of Mucositis

Affiliation(s): C.R.L.C. Oscar Lambret, 1 rue Frederic Combemale, B.P. 307 59020-Lille Cedex, France. jl-lefebvre@o-lambret.fr

Publication date & source: 2002-06, Oral Oncol., 38(4):337-42.

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

This randomized study compared the efficacy and safety of fluconazole suspension with that of amphotericin B suspension in patients with head and neck cancer who were suffering from candidiasis during cancer treatment with radiotherapy and/or chemotherapy. A total of 123 evaluable patients received 50 mg fluconazole once daily and 120 evaluable patients received 0.5 g amphotericin B thrice daily for 7-14 days depending on clinical response. A positive culture result was obtained in 121 of 264 (46%) patients; Candida albicans was most common. At the end of treatment, fluconazole and amphotericin B were equivalent (CI(90) of -10.7 to +14.9) in terms of clinical cure and improvement, but the rate of mycologic cure was higher for fluconazole (48%) than amphotericin B (35%). The incidence of adverse events was 39% for fluconazole and 44% for amphotericin B. Fluconazole suspension appeared effective and safe.