title: 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.
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.
authors.affiliation: University of Genoa, National Cancer Research Institute, Genoa, Italy. renzo.corvo@unige.it
authors.forename: R
authors.initials: R
authors.lastname: Corvò
authors.forename: M
authors.initials: M
authors.lastname: Amichetti
authors.forename: A
authors.initials: A
authors.lastname: Ascarelli
authors.forename: G
authors.initials: G
authors.lastname: Arcangeli
authors.forename: A
authors.initials: A
authors.lastname: Buffoli
authors.forename: N
authors.initials: N
authors.lastname: Cellini
authors.forename: L
authors.initials: L
authors.lastname: Cionini
authors.forename: C
authors.initials: C
authors.lastname: De Renzis
authors.forename: E
authors.initials: E
authors.lastname: Emiliani
authors.forename: P
authors.initials: P
authors.lastname: Franchini
authors.forename: P
authors.initials: P
authors.lastname: Gabriele
authors.forename: C
authors.initials: C
authors.lastname: Gobitti
authors.forename: F
authors.initials: F
authors.lastname: Grillo Ruggieri
authors.forename: F
authors.initials: F
authors.lastname: Bertoni
authors.forename: S M
authors.initials: SM
authors.lastname: Magrini
authors.forename: L
authors.initials: L
authors.lastname: Marmiroli
authors.forename: M
authors.initials: M
authors.lastname: Orsatti
authors.forename: G M
authors.initials: GM
authors.lastname: Panizza
authors.forename: M
authors.initials: M
authors.lastname: Tordiglione
authors.forename: L
authors.initials: L
authors.lastname: Ziccarelli
authors.forename: A
authors.initials: A
authors.lastname: Gava
authors.forename: P L
authors.initials: PL
authors.lastname: Zorat
authors.forename: R
authors.initials: R
authors.lastname: Ghelfi
authors.forename: G F
authors.initials: GF
authors.lastname: Serra
authors.forename: V
authors.initials: V
authors.lastname: Vitale
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000627:therapeutic use*; D002180:Candidiasis, Oral / Q000150:complications / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D015725:Fluconazole / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000150:complications / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections / Q000150:complications / Q000517:prevention & control*; D010608:Pharyngeal Diseases / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D015725:Fluconazole