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Astellas Pharma Inc.

Focus on Fungal Infections Newsletter
Focus on Fungal Infections Newsletter

Focus on Preventive Aspects of Antifungal Therapy ...


Dr. Thomas Walsh from the National Cancer Institute gave a keynote address entitled “Preventative Aspects of Antifungal Therapy—Making Sense of Presumptive vs Preemptive vs Prophylactic vs Maintenance Strategies.” He stressed that clinical interventions physicians use to manage patients at risk of developing invasive fungal infections (IFI) have a solid foundation in pre-clinical science. This gives clinicians confidence when they intervene with particular treatment strategies. Subsequent clinical investigations have made it possible to identify patients at high risk for developing IFI so that physicians can administer antifungal therapy earlier. Dr. Walsh identified a number of patient groups likely to benefit from early treatment: cancer and BMT patients, HIV/AIDS, SOT, ICU and surgical patients, along with low-birth-weight infants, individuals with inherited immunodeficiencies, and even patients with metabolic disorders such as diabetes. He chose to focus his presentation on cancer and BMT patients and outlined 3 strategies that are currently being used to reduce the incidence of IFIs during neutropenia in these patient populations. These strategies—prophylaxis, empirical therapy, and preemptive therapy—have been shown to improve outcomes in both pre-clinical and clinical studies.

Prophylactic therapy : The initiation of antifungal therapy at or near the time of the beginning of antineoplastic therapy, or prior to the stem cell transplantation preparative regimen.

Empirical therapy : A risk-based intervention for patients with persistent fever and neutropenia despite broad-spectrum antibiotics.

Preemptive therapy : Similar to empirical therapy; a risk-based intervention for patients with persistent fever and neutropenia despite broad-spectrum antibiotics, with additional evidence of the presence of a fungal infection.



Dr. Walsh defined prophylaxis as the initiation of antifungal therapy at or near the time of beginning anti-neoplastic therapy or prior to the stem cell transplantation preparative regimen. Prophylactic treatment may be continued beyond the period of neutropenia and through the high-risk period of post-engraftment. To illustrate the importance of pre-clinical science as a foundation for prophylactic strategies, Dr. Walsh reviewed several studies of disseminated candidiasis in animals. For example, the efficacy of fluconazole in the prevention of invasive candidiasis in high-risk neutropenic patients was predicted in animal models. In vitro experiments with the echinocandins have shown that they are active against both Candida albicans and non-albicans species, including Aspergillus species. These results have guided the clinical trial development of this new class of drugs, such as the randomized, multicenter trial (MSG-46) of micafungin versus fluconazole in the treatment of IFI in BMT patients. Dr. Walsh summarized the results of this trial by saying, “We found the activity [of micafungin] was similar to fluconazole in prevention of invasive candidiasis. We also found that there was a trend towards a greater reduction of invasive aspergillosis; it was not statistically significant, but the trend was nonetheless there.” There was also a significant reduction in the use of empirical antifungal therapy.

Empirical therapy was defined by Dr. Walsh as a risk-based intervention for patients with persistent fever and neutropenia despite broad-spectrum antibiotics, typically patients with acute leukemia, or those receiving intensive myeloablative therapy or an aggressive autologous transplant. Empirical therapy has two goals: early treatment of occult IFI, and the prevention of subsequent breakthrough fungal infections in high-risk patients. Randomized studies conducted in the 1980s demonstrated that amphotericin B reduced the incidence of breakthrough fungal infections in neutropenic patients with continued fever treated with antibiotic therapy, and provided the necessary evidence to make empirical therapy the standard of care in these patients.

Reporting on the recently published voriconazole vs liposomal amphotericin B trial,1 Dr. Walsh emphasized once again that the clinical development of voriconazole was based on a strong foundation in pre-clinical science. For example, the activity of voriconazole against various fungal pathogens was consistent with pre-clinical data in this trial; voriconazole showed activity against Aspergillus and Candida, but not against the Zygomycetes.

Preemptive therapy was defined as a form of empirical therapy with additional evidence of the presence of a fungal infection such as a positive surveillance culture, a sinusoid calcification, a pulmonary infiltrate, or a positive galactomannan antigen.

Dr. Walsh concluded by stating that, in the future, the introduction of the second-generation triazoles and the echinocandins into clinical trials will challenge the current strategies for preventing IFI in high-risk patients. He hopes that rigorous clinical trials will be conducted to test the hypotheses that are being generated in pre-clinical studies.

References:

1.  Walsh TJ, Pappas P, Winston DJ, et al. Voriconazole compared with liposomal amphotericin B for empirical antifungal therapy in patients with neutropenia and persistent fever. N Engl J Med 2002;346(4):225–34

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