Comparison of the efficacy and safety of miconazole 50-mg mucoadhesive buccal tablets with miconazole 500-mg gel in the treatment of oropharyngeal candidiasis

A prospective, randomized, single-blind, multicenter, comparative, phase III trial in patients treated with radiotherapy for head and neck cancer

Authors


  • The following are investigators of the BA2002/01/02 Head and Neck Study Group: France: R.J. Bensadoun, (Nice), L. Bastit (Rouen), A. Rosikon (Aulnay-sous-Bois), P. Céruse (Pierre-Benite), G. Calais (Tours), A. Risgallah (Dax), P. Dexemple (Périgueux), S. Turki (La Rochelle), R. Gourmet (Lyon), C. Allavena (Nantes), P. Desprez (Vannes), D. Garcia (Arcachon), J. F. Filippini (Bordeaux), M. Le Bourgeois (St. Jean de Luz), F. Lesaunier, B. Gery (Caen), M. Graff and M. Lapeyre (Nancy), D. Atlan (Paris), A. Hasbini (St. Brieuc), M. Urbajtel (Argenteuil), J. P. Margainaud (Villejuif), S. Reibel and J. P. Wagner (Strasbourg), J. L. Bernardini (Marseille), D. Goullet de Rugy (Caen), C. De Villepoix-Dore (Neuilly/Seine), S. Racadot (Paris), and P. Vergnolles and D. Vigneau (Bayonne); Tunisia: J. Daoud (Sfax), F. Ben-Ayed (Tunis), R. Ellouz (Tunis), W. Msedi (Sfax), and N. Bouaouina (Sousse); Morocco: B. El Gueddari (Rabat) and A. Benider (Casablanca); and Algeria: K. Boualga (Blida), A. Djemaa (Constantine), and A. F. Dali Youcef (Oran).

Abstract

BACKGROUND.

Topical antifungal treatments are recommended but rarely used as first-line therapy for oropharyngeal candidiasis (OPC) in patients with cancer. Miconazole Lauriad 50-mg mucoadhesive buccal tablet (MBT) Loramyc reportedly delivered rapid and prolonged, effective concentrations of miconazole in the mouth. The objective of the current study was to compare MBT with miconazole 500-mg oral gel (MOG) in patients with head and neck cancer.

METHODS.

Two hundred eighty-two patients with head and neck cancer received a 14-day treatment of either single-dose MBT or MOG administered in 4 divided doses. The primary endpoint was clinical success at Day 14, and secondary endpoints included clinical success at Day 7, clinical cure, improvement in clinical symptoms, mycologic cure, recurrence rate, and safety.

RESULTS.

The success rate was statistically not inferior (P < .0001) in the MBT population to the rate observed in the MOG group (56% vs 49%, respectively; P < .0001). After adjustment for the extent of lesions and salivary secretions, a trend toward superiority was observed in favor of MBT (P = .13), particularly among patients with multiple lesions (P = .013). Results for secondary endpoints were comparable to those observed for the primary endpoint. Compliance with MBT was excellent, and >80% of patients completed treatment. Both treatments were safe.

CONCLUSIONS.

The success rate of MBT Loramyc was significantly not inferior to that of MOG in the treatment of cancer patients with OPC; and, after adjusting for prognostic variables, it was more effective than MOG. MBT was well tolerated and, thus, may be recommended as first-line treatment in cancer patients who have OPC as an alternative to systemic antifungal agents. Cancer 2008. © 2007 American Cancer Society.

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