An EORTC Phase II study of caspofungin as first-line therapy of invasive aspergillosis in haematological patients.

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Serval ID
serval:BIB_C47DE3F32CE4
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
An EORTC Phase II study of caspofungin as first-line therapy of invasive aspergillosis in haematological patients.
Journal
Journal of Antimicrobial Chemotherapy
Author(s)
Viscoli C., Herbrecht R., Akan H., Baila L., Sonet A., Gallamini A., Giagounidis A., Marchetti O., Martino R., Meert L., Paesmans M., Ameye L., Shivaprakash M., Ullmann A.J., Maertens J.
ISSN
1460-2091[electronic]
Publication state
Published
Issued date
2009
Volume
64
Number
6
Pages
1274-1281
Language
english
Abstract
OBJECTIVES: Caspofungin was evaluated as first-line monotherapy of invasive aspergillosis (IA) in patients with haematological malignancies and undergoing autologous transplants. METHODS: Adults with proven or probable IA, defined strictly according to EORTC-MSG criteria, were eligible. Those with possible IA were enrolled, but were not evaluable for efficacy unless upgraded to proven/probable disease within 7 days of registration based on investigations performed within 48 h after enrolment. Caspofungin dosage was 70 mg (day 1) followed by 50 mg/day. The primary endpoint was the proportion of patients with complete or partial response at the end of caspofungin therapy in the modified intention to treat (MITT) group; secondary endpoints were response and survival at day 84 and safety. RESULTS: In the MITT group (n = 61), 75% of patients had cancer not in remission (relapsing or refractory), 85% were neutropenic at enrolment and 49% had a Karnofsky score of < or =50. At end of treatment, 1 and 19 patients had complete and partial response, respectively [success rate 33% (20/61)], 9 (15%) achieved stabilization and 31 (51%) had disease progression. One patient was not evaluable. The 6 and 12 week survival rates were 66% (40/61) and 53% (32/60), respectively. Baseline characteristics associated with survival at day 84 were an underlying disease in remission (not relapsing or refractory) and Karnofsky score. Recovery from neutropenia at the end of treatment was also significantly associated with survival. No serious drug-related adverse events or discontinuations due to drug-related adverse events were observed. CONCLUSIONS: Caspofungin provided an observed response rate compatible with the null hypothesis of a true response rate of < or =35%. Underlying disease-related factors had a major impact on results.
Keywords
Acute Leukaemia, Fungal Infections, Echinocandins, Bone-Marrow-Transplantation, Stem-Cell Transplants, Mycoses Study-Group, Fungal-Infections, Prognostic-Factors, European-Organization, Amphotericin-B, Consensus, Epidemiology, Voriconazole
Pubmed
Web of science
Open Access
Yes
Create date
03/12/2009 17:33
Last modification date
25/09/2019 7:10
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