Oral Oncology
Volume 38, Issue 4 , Pages 337-342, June 2002

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

  • Jean-Louis Lefebvre

      Affiliations

    • C.R.L.C. Oscar Lambret, 1 rue Frédéric Combemale, B.P. 307 59020- Lille Cedex, France
    • Corresponding Author InformationCorresponding author. Tel.: +33-3-20-29-55-31; fax: +33-3-20-29-59-61
    • On behalf of the Study Group on Mucositis.
    • ,
  • Christian Domenge

      Affiliations

    • Institut Gustave Roussy, 39 rue Camille Desmoulins, 94805 - Villejuif Cedex, France
    • On behalf of the Study Group on Mucositis.

Received 26 February 2001; received in revised form 21 March 2001; accepted 23 May 2001.

Abstract 

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 (CI90 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.

Keywords:  Amphotericin B, Comparative study, Fluconazole, Head and neck neoplasms, Oral candidiasis, Suspension

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PII: S1368-8375(01)00063-X

Oral Oncology
Volume 38, Issue 4 , Pages 337-342, June 2002

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