Patients with invasive fungal sinusitis treated successfully with isavuconazole
Patients treated with isavuconazole as primary or salvage therapy for invasive fungal sinusitis experienced overall survival rates of 82% at 42 days and 70% at 84 days, according to study results published in Clinical Infectious Diseases.
The results were from a post-hoc analysis of two phase 3 trials of isavuconazole, which identified 50 patients in the trials with invasive fungal sinusitis.
“I proposed the study because of the patients I have cared for with invasive fungal sinusitis (IFS),” Marlene L. Durand, MD, an infectious disease physician at Harvard Medical School and Massachusetts General Hospital, told Healio. “This is a very rare but terrible infection, and information about potential therapeutic options is helpful.”
Durand and colleagues performed the post-hoc analysis on the SECURE and VITAL trials phase 3 international trials that enrolled patients from 2007 to 2013 (SECURE) and 2008 to 2013 (VITAL). According to the researchers, SECURE compared isavuconazole and voriconazole as the primary treatment for invasive fungal disease (IFD) in adults due to Aspergillus and other filamentous fungi, whereas VITAL assessed primary or salvage isavuconazole treatment of adults with invasive aspergillosis who had renal impairment or adults with IFD due to rare molds.
Durand and colleagues reviewed the data from all patients in both trials who were treated with isavuconazole and had at least one sinus site of IFD. The main study outcomes were overall survival, and clinical and overall response to isavuconazole.
Of the 50 patients included in the study, 44 had IFS diagnosed by sinonasal (43) or brain (one) biopsy and six had probable IFD at a remote site but met criteria for probable IFS. According to the study, 34% of patients received isavuconazole as salvage therapy, 34% had disseminated IFD and 90% were immunocompromised or had diabetes. Mucormycetes were the pathogens associated with 17 patients, whereas another four had mixed mucormycetes plus Aspergillus infections.
According to the study, the primary therapy group consisting of 33 patients received isavuconazole for a median of 78 days and 24 received it for a month or more, whereas the salvage therapy group of 17 patients received isavuconazole for a median of 141 days and 12 received it for 1 month or more.
Overall survival was 82% at day 42 and 70% at day 84. Researchers found that of the 15 deaths by day 84, 11 were attributed by the data review committee to IFD, one died with residual or ongoing IFD, two were presumed and one was unrelated.
The researchers said day 84 survival rates were higher in primary than salvage therapy groups, higher among men than women, higher among immunocompetent than immunocompromised patients, higher in those without central nervous system involvement, higher among those with diabetes alone vs. hematologic malignancies, higher among patients with localized vs. disseminated IFD and higher among those with Aspergillus vs. mucormycetes infections.
“I believe that there are many factors to consider in treating a patient with invasive fungal sinusitis, and treatment should be individualized,” Durand said. “However, this study found that a number of patients with invasive fungal sinusitis have been treated successfully with isavuconazole, including some patients with infections refractory to other antifungal therapies.”