PRIMARY POSACONAZOLE PROPHYLAXIS IN ACUTE MYELOID LEUKEMIA - A SINGLE CENTER REAL LIFE EXPERIENCE
(Abstract release date: 05/18/17)
EHA Library. Fıratlı Tuğlular T. 05/18/17; 182395; PB1681
Tülin Fıratlı Tuğlular
Contributions
Contributions
Abstract
Abstract: PB1681
Type: Publication Only
Background
Invasive fungal infections (IFI) are a major cause of mortality and morbidity in acute myeloid leukemia (AML) patients receiving remission induction therapy, and relapsed/refractory AML patients. Posaconazole prophylaxis has shown the greatest benefit in preventing IFI in AML .
Aims
We present the data of our real-life experience in AML patients under PP
Methods
We have retrospectively reviewed the data from 82 AML patients receiving 105 cycles of chemotherapy between June 2012 and December 2016 in Marmara University Pendik Research and Training Hospital. Median patient age was 50 years (18-73); and there was no significant gender difference (38 female vs 44 male (46% vs 54%)). All patients had active disease, 78 (74.3%) of them received 3 + 7 (idarubicine - ara-c), 25 (23.8%) of them FLAG-Ida, 1 patient received EMA and 1 patient received CLARA chemotherapy protocol. Acute promyelocytic leukemia was excluded from the analysis. All patients received posaconazole as oral suspension at the dose of 200 miligrams three times daily starting on the first day of chemotherapy. Prophylaxis was continued until marrow regeneration, or occurrence of IFI, or onset of adverse events, or discontinuation due to other reasons. All fungal infections were classified as possible, probable, or proven according to European Organization for the Research and Treatment of Cancer (EORTC) and the Mycoses Study Group (MSG) consensus criteria.
Results
Mean posaconazole prophylaxis duration was 20±13 (1-68) days. This duration was 29.7 days (16-50) in patients receiving prophylaxis until marrow recovery, 18.9 (9-34) days in patients developing IFI under prophylaxis, and 12.7 days (1-68) in prophylaxis discontinuations due to adverse events and other reasons. Posaconazole prophylaxis was administered until marrow recovery without IFI (clinical success rate) in 42 of 105 (40%) chemotherapy cycles. In 18 cycles prophylaxis was stopped after diagnosis of IFI (%17.1). Discontinuations were due to adverse events in 6 cycles (5.7%), and due to other reasons (diarrhea, intolerance of oral medication, recurrent high grade fever, death) in 39 cycles (37.1%). IFI incidence under effective posaconazole prophylaxis was 28.1% (18/64). Total clinical failure rate was 60% (63/105). IFI was diagnosed with pulmonary nodules in 12 of 18 patients (66.6%; EORTC-MSG: possible), with galactomannan positivity in 3 patients (16.6%; EORTC-MSG: probable), and with fungal culture in 3 patients (16.6%; EORTC-MSG: proven). Data from 70 patients were available for mortality analysis. In patients receiving effective posaconazole prophylaxis, all-cause mortality rate at day 100 was (9/44; 20.4%) significantly lower than patients unable to continue posaconazole prophylaxis (12/26; 46.1%) (p:0.023). In the subset of patients receiving prophylaxis as planned; there was no statistically significant difference in IFI incidence between previously untreated AML (13/46; 28.2%) and relapsed/refractory AML (5/18; 27.7%).
Conclusion
In our real-life experience, we have demonstrated early survival benefit in patients receiving effective posaconazole prophylaxis. Although our IFI rate was comparable to other real-life data, our clinical failure rate was slightly higher. This is probably due to compliance issues, since in many chemotherapy cycles (37.1%) posaconazole was discontinued due to “other reasons” such as drug intolerance. Although not as effective as in the clinical trials; our data still supports the use of posaconazole prophylaxis in high risk AML patients.
Session topic: 4. Acute myeloid leukemia - Clinical
Keyword(s): AML, Prophylaxis, Fungal infection
Abstract: PB1681
Type: Publication Only
Background
Invasive fungal infections (IFI) are a major cause of mortality and morbidity in acute myeloid leukemia (AML) patients receiving remission induction therapy, and relapsed/refractory AML patients. Posaconazole prophylaxis has shown the greatest benefit in preventing IFI in AML .
Aims
We present the data of our real-life experience in AML patients under PP
Methods
We have retrospectively reviewed the data from 82 AML patients receiving 105 cycles of chemotherapy between June 2012 and December 2016 in Marmara University Pendik Research and Training Hospital. Median patient age was 50 years (18-73); and there was no significant gender difference (38 female vs 44 male (46% vs 54%)). All patients had active disease, 78 (74.3%) of them received 3 + 7 (idarubicine - ara-c), 25 (23.8%) of them FLAG-Ida, 1 patient received EMA and 1 patient received CLARA chemotherapy protocol. Acute promyelocytic leukemia was excluded from the analysis. All patients received posaconazole as oral suspension at the dose of 200 miligrams three times daily starting on the first day of chemotherapy. Prophylaxis was continued until marrow regeneration, or occurrence of IFI, or onset of adverse events, or discontinuation due to other reasons. All fungal infections were classified as possible, probable, or proven according to European Organization for the Research and Treatment of Cancer (EORTC) and the Mycoses Study Group (MSG) consensus criteria.
Results
Mean posaconazole prophylaxis duration was 20±13 (1-68) days. This duration was 29.7 days (16-50) in patients receiving prophylaxis until marrow recovery, 18.9 (9-34) days in patients developing IFI under prophylaxis, and 12.7 days (1-68) in prophylaxis discontinuations due to adverse events and other reasons. Posaconazole prophylaxis was administered until marrow recovery without IFI (clinical success rate) in 42 of 105 (40%) chemotherapy cycles. In 18 cycles prophylaxis was stopped after diagnosis of IFI (%17.1). Discontinuations were due to adverse events in 6 cycles (5.7%), and due to other reasons (diarrhea, intolerance of oral medication, recurrent high grade fever, death) in 39 cycles (37.1%). IFI incidence under effective posaconazole prophylaxis was 28.1% (18/64). Total clinical failure rate was 60% (63/105). IFI was diagnosed with pulmonary nodules in 12 of 18 patients (66.6%; EORTC-MSG: possible), with galactomannan positivity in 3 patients (16.6%; EORTC-MSG: probable), and with fungal culture in 3 patients (16.6%; EORTC-MSG: proven). Data from 70 patients were available for mortality analysis. In patients receiving effective posaconazole prophylaxis, all-cause mortality rate at day 100 was (9/44; 20.4%) significantly lower than patients unable to continue posaconazole prophylaxis (12/26; 46.1%) (p:0.023). In the subset of patients receiving prophylaxis as planned; there was no statistically significant difference in IFI incidence between previously untreated AML (13/46; 28.2%) and relapsed/refractory AML (5/18; 27.7%).
Conclusion
In our real-life experience, we have demonstrated early survival benefit in patients receiving effective posaconazole prophylaxis. Although our IFI rate was comparable to other real-life data, our clinical failure rate was slightly higher. This is probably due to compliance issues, since in many chemotherapy cycles (37.1%) posaconazole was discontinued due to “other reasons” such as drug intolerance. Although not as effective as in the clinical trials; our data still supports the use of posaconazole prophylaxis in high risk AML patients.
Session topic: 4. Acute myeloid leukemia - Clinical
Keyword(s): AML, Prophylaxis, Fungal infection
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