Effects of fluconazole in the prophylaxis of oropharyngeal candidiasis in patients undergoing radiotherapy for head and neck tumour: Results from a double-blind placebo-controlled trial: Original article

R. Corvò, M. Amichetti, A. Ascarelli, G. Arcangeli, A. Buffoli, N. Cellini, L. Cionini, C. De Renzis, E. Emiliani, P. Franchini, P. Gabriele, C. Gobitti, F. Grillo Ruggieri, F. Bertoni, S. M. Magrini, L. Marmiroli, M. Orsatti, G. M. Panizza, M. Tordiglione, L. ZiccarelliA. Gava, P. L. Zorat, R. Ghelfi, G. F. Serra, V. Vitale

Research output: Contribution to journalArticle

Abstract

Fluconazole is recommended in the prophylaxis of oropharyngeal candidiasis (OPC) in patients undergoing radiotherapy for head-neck tumours; however, the actual effectiveness of fluconazole in this setting remains unclear. Adult patients with cervico-cephalic carcinoma submitted to radical or adjuvant radiotherapy were randomized to 100 mg fluconazole (n = 138) or matched placebo (n = 132) oral suspension once daily from the sixth session of radiotherapy up to the end of treatment. The final analysis of the investigation showed a higher rate of the OPC outbreak-free survival in the fluconazole compared with placebo (P = 0.008 in the log-rank test). The mean time (95% CI) to OPC outbreak was 56 (53-59) days in the fluconazole group and 47 (43-51) days with placebo. The mean duration of radiotherapy was 43.5 and 39.9 days, respectively in the two groups (P = 0.027). Adverse effects were reported in 70.3% of patients in the fluconazole group and in 67.4% with placebo. The results showed prophylaxis with fluconazole given in irradiated patients with head-neck tumours significantly reduces the rate and the time to development of OPC compared with placebo.

Original languageEnglish
Pages (from-to)270-277
Number of pages8
JournalEuropean Journal of Cancer Care
Volume17
Issue number3
DOIs
Publication statusPublished - May 2008

Keywords

  • Fluconazole
  • Head and neck cancer
  • Oropharyngeal candidiasis
  • Radiotherapy

ASJC Scopus subject areas

  • Nursing(all)
  • Oncology
  • Rehabilitation
  • Health Professions(all)

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    Corvò, R., Amichetti, M., Ascarelli, A., Arcangeli, G., Buffoli, A., Cellini, N., Cionini, L., De Renzis, C., Emiliani, E., Franchini, P., Gabriele, P., Gobitti, C., Grillo Ruggieri, F., Bertoni, F., Magrini, S. M., Marmiroli, L., Orsatti, M., Panizza, G. M., Tordiglione, M., ... Vitale, V. (2008). Effects of fluconazole in the prophylaxis of oropharyngeal candidiasis in patients undergoing radiotherapy for head and neck tumour: Results from a double-blind placebo-controlled trial: Original article. European Journal of Cancer Care, 17(3), 270-277. https://doi.org/10.1111/j.1365-2354.2007.00855.x