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

https://www.ncbi.nlm.nih.gov/pubmed/30035825

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.