“…Even though ISA was well tolerated, the cumulative incidence of all bIFI cases was higher than that published in prior studies (3.2–8.5%), 14,15,17,19,22,24–27,30–32 but similar to Bose et al. (18%) 16 .…”
Section: Discussionsupporting
confidence: 76%
“…We evaluated for potential risk factors that could lead to the occurrence of bIFIs unfortunately, none were statistically significant. Even though ISA was well tolerated, the cumulative incidence of all bIFI cases was higher than that published in prior studies (3.2-8.5%), 14,15,17,19,22,[24][25][26][27][30][31][32] 16,19 . Although bIFIs with Candida and Aspergillus have been reported, 14,16,17,19,[22][23][24]26 we also had a significant number of Fusarium (3/13, 23.1%) and Mucor (3/13, 23.1%) species.…”
Section: Discussioncontrasting
confidence: 65%
“…We attempted to compare certain patient characteristics such as number of patients with HM and TCT, underlying chemotherapy regimens, proportion of patients with R/R clinical status, and presence of graft-versus-host disease (GVHD); between our patient populations with those of prior studies. [14][15][16][17]19,[22][23][24][25][26][27][28][29][30][31][32] However, given the significant heterogeneity among the different patient groups, this was difficult to accomplish. 24 This heterogeneity of patient populations would also limit direct comparisons in all-cause mortality.…”
Section: Discussionmentioning
confidence: 99%
“…Another limitation is that as the selection of ISA as a prophylactic agent was at the discretion of the treating hematologist, this may have led to potential selection bias of higher‐risk patients. We attempted to compare certain patient characteristics such as number of patients with HM and TCT, underlying chemotherapy regimens, proportion of patients with R/R clinical status, and presence of graft‐versus‐host disease (GVHD); between our patient populations with those of prior studies 14–17,19,22–32 . However, given the significant heterogeneity among the different patient groups, this was difficult to accomplish 24 .…”
Section: Discussionmentioning
confidence: 99%
“…14,15 To date, there have been very few prospective studies that evaluated use of ISA as a prophylactic antifungal agent in patients with HM and/or TCT recipients-further data on the prophylactic efficacy of ISA in HM patients and TCT recipients is still lacking. 16,17 Breakthrough IFIs (bIFIs) have been reported in patients receiving prophylaxis with VOR (1.1−13%), 7,18,19 and POS (2−18.9%), [19][20][21] as well as those receiving ISA (3.2-16.3%), [14][15][16][17]19,[22][23][24][25][26][27][28][29][30][31][32] however, studies have not reported on risk factors related to bIFI occurrence.…”
BackgroundIsavuconazole (ISA) is a newer antifungal used in patients with history of hematologic malignancies and hematopoietic transplant and cellular therapies (HM/TCT). Although it has a more favorable side‐effect profile, breakthrough invasive fungal infections (bIFIs) while on ISA have been reported.MethodsIn this single‐center retrospective study evaluating HM/TCT patients who received prophylactic ISA for ≥7 days, we evaluated the incidence and potential risk factors for bIFIs.ResultsWe evaluated 106 patients who received prophylactic ISA. The patients were predominantly male (60.4%) with median age of 65 (range: 21–91) years. Acute myeloid leukemia (48/106, 45.3%) was the most common HM, with majority having relapsed and/or refractory disease (43/106, 40.6%) or receiving ongoing therapy (38/106, 35.8%).Nineteen patients (17.9%) developed bIFIs–nine proven [Fusarium (3), Candida (2), Mucorales plus Aspergillus (2), Mucorales (1), Colletotrichum (1)], four probable invasive pulmonary Aspergillus, and six possible infections. Twelve patients were neutropenic for a median of 28 (8–253) days prior to bIFI diagnosis. ISA levels checked within 7 days of bIFI diagnosis (median: 3.65 μg/mL) were comparable to industry‐sponsored clinical trials.All‐cause mortality among the bIFI cases was 47.4% (9/19).We also noted clinically significant cytomegalovirus co‐infection in 5.3% (1/19). On univariate analysis, there were no significant differences in baseline comorbidities and potential risk factors between the two groups.ConclusionISA prophylaxis was associated with a significant cumulative incidence of bIFIs. Despite the appealing side‐effect and drug‐interaction profile of ISA, clinicians must be vigilant about the potential risk for bIFIs.
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“…Even though ISA was well tolerated, the cumulative incidence of all bIFI cases was higher than that published in prior studies (3.2–8.5%), 14,15,17,19,22,24–27,30–32 but similar to Bose et al. (18%) 16 .…”
Section: Discussionsupporting
confidence: 76%
“…We evaluated for potential risk factors that could lead to the occurrence of bIFIs unfortunately, none were statistically significant. Even though ISA was well tolerated, the cumulative incidence of all bIFI cases was higher than that published in prior studies (3.2-8.5%), 14,15,17,19,22,[24][25][26][27][30][31][32] 16,19 . Although bIFIs with Candida and Aspergillus have been reported, 14,16,17,19,[22][23][24]26 we also had a significant number of Fusarium (3/13, 23.1%) and Mucor (3/13, 23.1%) species.…”
Section: Discussioncontrasting
confidence: 65%
“…We attempted to compare certain patient characteristics such as number of patients with HM and TCT, underlying chemotherapy regimens, proportion of patients with R/R clinical status, and presence of graft-versus-host disease (GVHD); between our patient populations with those of prior studies. [14][15][16][17]19,[22][23][24][25][26][27][28][29][30][31][32] However, given the significant heterogeneity among the different patient groups, this was difficult to accomplish. 24 This heterogeneity of patient populations would also limit direct comparisons in all-cause mortality.…”
Section: Discussionmentioning
confidence: 99%
“…Another limitation is that as the selection of ISA as a prophylactic agent was at the discretion of the treating hematologist, this may have led to potential selection bias of higher‐risk patients. We attempted to compare certain patient characteristics such as number of patients with HM and TCT, underlying chemotherapy regimens, proportion of patients with R/R clinical status, and presence of graft‐versus‐host disease (GVHD); between our patient populations with those of prior studies 14–17,19,22–32 . However, given the significant heterogeneity among the different patient groups, this was difficult to accomplish 24 .…”
Section: Discussionmentioning
confidence: 99%
“…14,15 To date, there have been very few prospective studies that evaluated use of ISA as a prophylactic antifungal agent in patients with HM and/or TCT recipients-further data on the prophylactic efficacy of ISA in HM patients and TCT recipients is still lacking. 16,17 Breakthrough IFIs (bIFIs) have been reported in patients receiving prophylaxis with VOR (1.1−13%), 7,18,19 and POS (2−18.9%), [19][20][21] as well as those receiving ISA (3.2-16.3%), [14][15][16][17]19,[22][23][24][25][26][27][28][29][30][31][32] however, studies have not reported on risk factors related to bIFI occurrence.…”
BackgroundIsavuconazole (ISA) is a newer antifungal used in patients with history of hematologic malignancies and hematopoietic transplant and cellular therapies (HM/TCT). Although it has a more favorable side‐effect profile, breakthrough invasive fungal infections (bIFIs) while on ISA have been reported.MethodsIn this single‐center retrospective study evaluating HM/TCT patients who received prophylactic ISA for ≥7 days, we evaluated the incidence and potential risk factors for bIFIs.ResultsWe evaluated 106 patients who received prophylactic ISA. The patients were predominantly male (60.4%) with median age of 65 (range: 21–91) years. Acute myeloid leukemia (48/106, 45.3%) was the most common HM, with majority having relapsed and/or refractory disease (43/106, 40.6%) or receiving ongoing therapy (38/106, 35.8%).Nineteen patients (17.9%) developed bIFIs–nine proven [Fusarium (3), Candida (2), Mucorales plus Aspergillus (2), Mucorales (1), Colletotrichum (1)], four probable invasive pulmonary Aspergillus, and six possible infections. Twelve patients were neutropenic for a median of 28 (8–253) days prior to bIFI diagnosis. ISA levels checked within 7 days of bIFI diagnosis (median: 3.65 μg/mL) were comparable to industry‐sponsored clinical trials.All‐cause mortality among the bIFI cases was 47.4% (9/19).We also noted clinically significant cytomegalovirus co‐infection in 5.3% (1/19). On univariate analysis, there were no significant differences in baseline comorbidities and potential risk factors between the two groups.ConclusionISA prophylaxis was associated with a significant cumulative incidence of bIFIs. Despite the appealing side‐effect and drug‐interaction profile of ISA, clinicians must be vigilant about the potential risk for bIFIs.
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