Galactomannan serves as a surrogate endpoint for outcome of pulmonary invasive aspergillosis in neutropenic hematology patients.

Johan Maertens, Kristel Buvé, Koen Theunissen, Wouter Meersseman, Eric Verbeken, Gregor Verhoef, Johan Van Eldere, Katrien Lagrou
Author Information
  1. Johan Maertens: Department of Hematology, University Hospital Gasthuisberg, Leuven, Belgium. johan.maertens@uz.kuleuven.ac.be

Abstract

BACKGROUND: A noninvasive, objective, reproducible, and quantitative Aspergillus-specific surrogate marker is needed for a more accurate assessment of the outcome of invasive aspergillosis (IA) in patients with a hematologic disorder. The quantitative serum galactomannan index (GMI) assay seems to fulfill the requirements of surrogacy for outcome evaluation.
METHODS: Kappa statistics were used to determine the strength of correlation between GMI outcome and clinical outcome (survival or death), autopsy data, and response outcome of IA in 70 adults with prolonged neutropenia. All patients underwent serial GMI monitoring until discharge or death.
RESULTS: The overall correlation between GMI and clinical outcome was good at 6 weeks (kappa=0.5882; 95% confidence interval [95% CI], 0.4023-0.7741) and was excellent at 12 weeks (kappa=0.8857; 95% CI, 0.7766-0.9948). Concordance with autopsy findings was perfect (kappa=1). At 6 weeks, the correlation between GMI and response outcome (favorable or unfavorable) was excellent (kappa=0.7523; 95% CI, 0.5803-0.9243). Survival was significantly better in patients who became GMI-negative (P<.0001).
CONCLUSIONS: In neutropenic patients with seropositive IA, serum galactomannan index outcome strongly correlates with survival, autopsy findings, and response outcome. This finding may have implications for patient management and for clinical trial design.

MeSH Term

Adolescent
Adult
Aged
Aged, 80 and over
Aspergillosis
Autopsy
Biomarkers
Female
Galactose
Humans
Male
Mannans
Middle Aged
Neutropenia
Survival Analysis
Time Factors
Treatment Outcome

Chemicals

Biomarkers
Mannans
galactomannan
Galactose

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