Treatment outcomes in patients with proven/probable versus possible invasive mould disease in a phase III trial comparing isavuconazole versus voriconazole.
Fiche publication
Date publication
juillet 2018
Journal
Mycoses
Auteurs
Membres identifiés du Cancéropôle Est :
Pr HERBRECHT Raoul
Tous les auteurs :
Maertens J, Selleslag D, Heinz WJ, Saulay M, Rahav G, Giladi M, Aoun M, Kovanda L, Kaufhold A, Engelhardt M, Cornely OA, Herbrecht R, Ullmann AJ
Lien Pubmed
Résumé
Treatment outcomes in patients with proven/probable vs possible invasive mould disease (IMD; 2008 European Organisation for Research and Treatment of Cancer/Mycoses Study Group [EORTC/MSG] criteria) needed further assessment. The Phase III SECURE trial compared isavuconazole vs voriconazole for treatment of IMD. This post hoc analysis assessed all-cause mortality (ACM) through day 42 (primary endpoint) and day 84, overall and clinical success at end of treatment (EOT), and drug-related treatment-emergent adverse-events (TEAEs) in subgroups with proven/probable or possible IMD. Of 516 randomised patients, 304 (58.9%) had proven/probable IMD and 164 (31.8%) had possible IMD as per EORTC/MSG criteria; 48 did not have IMD. Across treatment groups, day 42 and day 84 ACM were numerically lower for possible vs proven/probable IMD (day 42: 17.1% vs 21.1%; P = .3, day 84: 26.2% vs 32.6%; P = .15). Overall and clinical success at EOT were significantly higher for possible IMD compared with proven/probable IMD (48.2% vs 36.2%; P = .01, 75.0% vs 63.1%; P = .01, respectively). Fewer drug-related TEAEs were reported with isavuconazole compared with voriconazole in patients with either proven/probable or possible IMD. Compared with patients with proven/probable IMD, those with possible IMD demonstrated higher overall and clinical success rates, supporting early initiation of antifungal treatment. This article is protected by copyright. All rights reserved.
Mots clés
invasive mould disease, isavuconazole, possible IMD, proven/probable IMD, voriconazole
Référence
Mycoses. 2018 Jul 23;: