Prophylactic treatment of mycotic mucositis in radiotherapy of patients with head and neck cancers.

BACKGROUND

Patients undergoing radiotherapy for head and neck cancer are at increased risk of developing oral candidiasis. The objective of this study was to investigate the clinical Candida mucositis and interruptions in radiotherapy in patients suffering from head and neck cancer, receiving fluconazole in comparison with a control group without specific prophylaxis.

METHODS

Eighty consecutive patients were randomized in a prospective double-blind trial of prophylactic oral fluconazole or treatment with the same drug when mycotic infections appeared. Adult head and neck cancer patients who were undergoing treatment with radiotherapy and/or chemotherapy, radiotherapeutic coverage of the entire oropharynx and oral cavity at least 3 cm anterior to the retromolar trigone and receiving a total dose of more than 6000 cGy and Karnofsky Performance Status (KPS) >70 were included in the study. Group A received radiation therapy plus fluconazole (Fluzole 100 mg/day) starting from the sixth irradiation session throughout the treatment; 40 patients in group B received the same baseline treatment, but were given fluconazole only when mycotic infections appeared.

RESULTS

We evaluated 37 patients in group A and the first 37 patients were evaluated in group B. Three of the patients in group A (8.1%) and 14 of the patients in group B (37.8%) demonstrated clinical candidasis. Radiotherapy was interrupted in all of these patients. The differences between the two groups were statistically significant with respect to clinical candidiasis (P = 0.005). The median discontinuation time was 5 days (range, 3-7 days) in group A and 7 days (range, 4-10 days) in group B. The median dose resulting in clinical candidiasis was 3200 cGy (range, 2200-5800 cGy) in all groups. In the fluconazole group it was 4200 cGy and in the control group 2800 cGy.

CONCLUSION

These results suggest that patients undergoing head and neck radiation therapy are at risk of developing candidiasis and that fluconazole may be used to reduce the frequency of mycotic infections and to improve the radiotherapy schedule in head and neck cancer patients.