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Published on: April 19, 2017
Posaconazole vs. fluconazole as invasive fungal infection prophylaxis in China: a multicenter, randomized, open-label
Background:
Invasive fungal infection (IFI) is common in neutropenic patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS). Posaconazole is a broad-spectrum triazole antifungal drug with efficacy in prevention of IFI; however, it has not been previously studied as prophylaxis in a Chinese population.
Methods:
This multicenter, randomized study in China enrolled AML and MDS patients with persistent chemotherapy-induced neutropenia. Prophylaxis with posaconazole or fluconazole was administered for a maximum of 12 weeks, or until patients recovered from neutropenia and achieved complete remission or an IFI occurred. The primary endpoint was incidence of proven, probable, or possible IFI during treatment. Clinical failure rate, all-cause mortality and time to first systemic antifungal treatment were secondary endpoints.
Results:
Patients were randomized to receive posaconazole (n = 129) or fluconazole (n = 123); 117 patients in each group were included in the statistical analysis. The incidence of proven, probable or possible IFI was 9.4% (11/117) and 22.2% (26/117) in the posaconazole and fluconazole groups, respectively (p = 0.0114). The clinical failure rate was numerically lower in the posaconazole group (37/117 (31.6%; 95%CI: 23.3 - 40.9)) than in the fluconazole group (49/117 (41.88%; 95% CI: 32.8 - 51.4)) (p = 0.168). Patients receiving posaconazole had a later onset of first systematic antifungal treatment than those receiving fluconazole (p = 0.0139). The most common important adverse events were liver function abnormalities (11 patients (8.8%) on posaconazole and 6 (5.0%) on fluconazole (p = 0.221)).
Conclusions:
Posaconazole demonstrates efficacy as prophylaxis against IFI in high-risk neutropenic Chinese patients and is well tolerated during long-term use (ClinicalTrials. gov number, NCT00811928).
Insights
Posaconazole significantly reduced invasive fungal infections (IFIs) in Chinese patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS). This broad-spectrum antifungal was well-tolerated, offering a safer prophylaxis option for high-risk individuals.
Area of Science:
- Oncology
- Infectious Diseases
- Pharmacology
Background:
- Invasive fungal infections (IFIs) pose a significant risk to neutropenic patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).
- Posaconazole, a broad-spectrum triazole antifungal, has demonstrated efficacy in IFI prevention but lacked prior study in Chinese populations.
Purpose of the Study:
- To evaluate the efficacy and tolerability of posaconazole as prophylaxis against IFIs in Chinese patients with AML or MDS experiencing persistent neutropenia.
- To compare posaconazole with fluconazole for IFI prevention in this high-risk patient group.
Main Methods:
- A multicenter, randomized study in China enrolled AML and MDS patients with persistent chemotherapy-induced neutropenia.
- Patients received either posaconazole or fluconazole prophylaxis for up to 12 weeks.
- The primary endpoint was the incidence of proven, probable, or possible IFIs during treatment.
Main Results:
- The incidence of IFIs was significantly lower in the posaconazole group (9.4%) compared to the fluconazole group (22.2%) (p = 0.0114).
- Patients receiving posaconazole experienced a later onset of first systemic antifungal treatment (p = 0.0139).
- While not statistically significant, the clinical failure rate was numerically lower with posaconazole (31.6%) versus fluconazole (41.88%).
Conclusions:
- Posaconazole is effective and well-tolerated for IFI prophylaxis in high-risk neutropenic Chinese patients with AML or MDS.
- The study supports the use of posaconazole as a valuable long-term prophylactic option in this population.
