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

Fluconazoleis recommended in the prophylaxis of oropharyngeal candidiasis (OPC) in patients undergoing radiotherapy for head-neck tumours; however, the actual effectiveness of fluconazolein this setting remains unclear. Adult patients with cervico- cephaliccarcinoma 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 fluconazolecompared 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 fluconazolegroup 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 fluconazolegroup and in 67.4% with placebo. The results showed prophylaxis with fluconazolegiven in irradiated patients with head-neck tumours significantly reduces the rate and the time to development of OPC compared with placebo.