1. Treatment outcomes in patients with proven/probable vs possible invasive mould disease in a phase III trial comparing isavuconazole vs voriconazole.
- Author
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Maertens, Johan, Selleslag, Dominik, Heinz, Werner J., Saulay, Mikael, Rahav, Galia, Giladi, Michael, Aoun, Mickael, Kovanda, Laura, Kaufhold, Achim, Engelhardt, Marc, Cornely, Oliver A., Herbrecht, Raoul, and Ullmann, Andrew J.
- Subjects
HEMATOLOGY ,VORICONAZOLE ,ANTIFUNGAL agents ,ASPERGILLOSIS ,IMMUNOCOMPROMISED patients - Abstract
Summary: 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 = 0.3, day 84: 26.2% vs 32.6%; P = 0.15). Overall and clinical success at EOT were significantly higher for possible IMD compared with proven/probable IMD (48.2% vs 36.2%; P = 0.01, 75.0% vs 63.1%; P = 0.01 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. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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