Universität zu Köln

Maertens, Johan ORCID: 0000-0003-4257-5980, Selleslag, Dominik, Heinz, Werner J., Saulay, Mikael, Rahav, Galia, Giladi, Michael, Aoun, Mickael, Kovanda, Laura, Kaufhold, Achim, Engelhardt, Marc, Cornely, Oliver A., Herbrecht, Raoul ORCID: 0000-0002-9381-4876 and Ullmann, Andrew J. (2018). Treatment outcomes in patients with proven/probable vs possible invasive mould disease in a phase III trial comparing isavuconazole vs voriconazole. Mycoses, 61 (11). S. 868 - 877. HOBOKEN: WILEY. ISSN 1439-0507

Full text not available from this repository.

Abstract

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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Maertens, Johan UNSPECIFIED orcid.org/0000-0003-4257-5980 UNSPECIFIED Selleslag, Dominik UNSPECIFIED UNSPECIFIED UNSPECIFIED Heinz, Werner J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Saulay, Mikael UNSPECIFIED UNSPECIFIED UNSPECIFIED Rahav, Galia UNSPECIFIED UNSPECIFIED UNSPECIFIED Giladi, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Aoun, Mickael UNSPECIFIED UNSPECIFIED UNSPECIFIED Kovanda, Laura UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaufhold, Achim UNSPECIFIED UNSPECIFIED UNSPECIFIED Engelhardt, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED Cornely, Oliver A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Herbrecht, Raoul UNSPECIFIED orcid.org/0000-0002-9381-4876 UNSPECIFIED Ullmann, Andrew J. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-167219
DOI:	10.1111/myc.12831
Journal or Publication Title:	Mycoses
Volume:	61
Number:	11
Page Range:	S. 868 - 877
Date:	2018
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1439-0507
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CELL TRANSPLANT RECIPIENTS; LIPOSOMAL AMPHOTERICIN-B; EUROPEAN ORGANIZATION; FUNGAL-INFECTIONS; RANDOMIZED-TRIAL; 2008 DEFINITIONS; ASPERGILLOSIS; THERAPY; PHARMACOKINETICS; EPIDEMIOLOGY Multiple languages Dermatology; Mycology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/16721