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.

Systematic review of antimicrobials, mucosal coating agents, anesthetics, and analgesics for the management of oral mucositis in cancer patients

“…At the end of radiotherapy, severe OM was found less frequently in the prophylaxis group and they also had a significantly lower rate of treatment interruptions [62]. On the other hand, Corvo et al found that the use of fluconazole reduced the incidence of oropharyngeal candidiasis but had no impact on oral mucosal toxicity [26]. No guideline was possible due to insufficient evidence.…”

Oropharyngeal candidiasis in head and neck cancer patients treated with radiation: update 2011

“…Fluconazole can be used for secondary prophylaxis in cases of "severe or frequent" recurrences at a dosage of 50-200 mg/day or 100-400 mg/week, with proven efficacy superior to that of oral polyenes, and increased convenience of use [10,29,31,35]. Daily administration may be more effective than weekly schemes [20].…”

Criterios de Evaluación Odontológica Pre-Radioterapia y Necesidad de Tratamiento de las Enfermedades Orales Post-Radioterapia en Cabeza y Cuello

“…La candidosis es la infección más común de la cavidad oral de los pacientes que reciben radioterapia, y afecta generalmente paladar blando, lengua y mucosa yugal (Ramirez-Amador et al, 1997;Redding et al, 1999;Köstler et al;Grötz et al, 2003;Miller & Quinn;Corvò et al, 2008) (Figura 5). Generalmente es de tipo pseudomembranosa, caracterizada por la formación de placas blancas, removibles al raspado, aunque se puede presentar de tipo eritematosa en algunos casos (Lopes et al; Jham & Silva Freire).…”

“…Generalmente es de tipo pseudomembranosa, caracterizada por la formación de placas blancas, removibles al raspado, aunque se puede presentar de tipo eritematosa en algunos casos (Lopes et al; Jham & Silva Freire). Los principales factores de riesgo en pacientes irradiados para desarrollar candidosis son xerostomía, uso prótesis dental y tabaquismo (Redding et al;Nicolatou-Galitis et al, 2003;Sciubba & Goldenberg;Corvò et al).…”