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No advantage of antimicrobial prophylaxis in AML/MDS/CMML patients treated with azacitidine-a prospective multicenter
Krzysztof Mądry1, Karol Lis1, Elzbieta Sienkiewicz2
1Department of Hematology, Transplantation and Internal Diseases, Medical University of Warsaw, Warsaw, Poland.
Introduction:
Infections represent one of the most frequent causes of death of higher-risk MDS patients, as reported previously also by our group. Azacitidine Infection Risk Model (AIR), based on red blood cell (RBC) transfusion dependency, neutropenia <0.8 × 109/L, platelet count <50 × 109/L, albumin <35g/L, and ECOG performance status ≥2 has been proposed based on the retrospective data to estimate the risk of infection in azacitidine treated patients.
Methods:
The prospective non-intervention study aimed to identify factors predisposing to infection, validate the AIR score, and assess the impact of antimicrobial prophylaxis on the outcome of azacitidine-treated MDS/AML and CMML patients.
Results:
We collected data on 307 patients, 57.6 % males, treated with azacitidine: AML (37.8%), MDS (55.0%), and CMML (7.1%). The median age at azacitidine treatment commencement was 71 (range, 18-95) years. 200 (65%) patients were assigned to higher risk AIR group. Antibacterial, antifungal, and antiviral prophylaxis was used in 66.0%, 29.3%, and 25.7% of patients, respectively. In total, 169 infectious episodes (IE) were recorded in 118 (38.4%) patients within the first three azacitidine cycles. In a multivariate analysis ECOG status, RBC transfusion dependency, IPSS-R score, and CRP concentration were statistically significant for infection development (p < 0.05). The occurrence of infection within the first three azacitidine cycles was significantly higher in the higher risk AIR group - 47.0% than in lower risk 22.4% (odds ratio (OR) 3.06; 95% CI 1.82-5.30, p < 0.05). Administration of antimicrobial prophylaxis did not have a significant impact on all-infection occurrence in multivariate analysis: antibacterial prophylaxis (OR 0.93; 0.41-2.05, p = 0.87), antifungal OR 1.24 (0.54-2.85) (p = 0.59), antiviral OR 1.24 (0.53-2.82) (p = 0.60).
Discussion:
The AIR Model effectively discriminates infection-risk patients during azacitidine treatment. Antimicrobial prophylaxis does not decrease the infection rate.
Insights
The Azacitidine Infection Risk (AIR) Model accurately identifies patients at high risk for infections during azacitidine treatment. Antimicrobial prophylaxis did not significantly reduce infection rates in this study population.
Area of Science:
- Hematology
- Oncology
- Infectious Diseases
Background:
- Infections are a leading cause of mortality in higher-risk myelodysplastic syndrome (MDS) patients.
- The Azacitidine Infection Risk (AIR) Model was previously developed to predict infection risk in azacitidine-treated patients.
Purpose of the Study:
- To prospectively identify infection risk factors in azacitidine-treated patients.
- To validate the AIR score's predictive capability.
- To assess the impact of antimicrobial prophylaxis on infection outcomes.
Main Methods:
- A prospective, non-intervention study involving 307 patients with AML, MDS, or CMML treated with azacitidine.
- Data collected included patient demographics, clinical factors, and use of antimicrobial prophylaxis.
- Multivariate analysis was used to identify significant risk factors and assess prophylaxis impact.
Main Results:
- The AIR Model effectively stratified patients into higher (65%) and lower infection risk groups.
- Higher risk AIR group patients had a significantly higher infection rate (47.0%) compared to lower risk (22.4%).
- Antimicrobial prophylaxis (antibacterial, antifungal, antiviral) did not show a significant impact on reducing overall infection occurrence.
Conclusions:
- The AIR Model is a validated tool for discriminating infection risk in azacitidine-treated patients.
- Current antimicrobial prophylaxis strategies did not demonstrate a significant benefit in lowering infection rates in this cohort.
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