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.
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.
Corvò
R
R
University of Genoa, National Cancer Research Institute, Genoa, Italy. renzo.corvo@unige.it
Amichetti
M
M
Ascarelli
A
A
Arcangeli
G
G
Buffoli
A
A
Cellini
N
N
Cionini
L
L
De Renzis
C
C
Emiliani
E
E
Franchini
P
P
Gabriele
P
P
Gobitti
C
C
Grillo Ruggieri
F
F
Bertoni
F
F
Magrini
S M
SM
Marmiroli
L
L
Orsatti
M
M
Panizza
G M
GM
Tordiglione
M
M
Ziccarelli
L
L
Gava
A
A
Zorat
P L
PL
Ghelfi
R
R
Serra
G F
GF
Vitale
V
V
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
D000935:Antifungal Agents; D015725:Fluconazole