EFFICACY AND SAFETY OF MICAFUNGIN ON THE MANAGEMENT OF INVASIVE FUNGAL INFECTIONS AMONG PATIENTS WITH HEMATOLOGICAL MALIGNANCIES AT TERTIARY HOSPITALS IN GREECE- THE ASPIRE STUDY
(Abstract release date: 05/19/16)
EHA Library. Kotsopoulou M. 06/09/16; 132733; E1184
Maria Kotsopoulou
Contributions
Contributions
Abstract
Abstract: E1184
Type: Eposter Presentation
Background
Immunocompromised patients, especially those with cancer or underling hematological malignancies and patients who undergo hematopoietic stem cell transplantation (HSCT), are at high risk for invasive fungal infections, which are often life threatening. Echinocandins are recommended as first -line treatment for the management of invasive candidiasis/candidemia from the recent ESCMID guidelines. However, there are relatively limited data for the daily clinical practice regarding the use of micafungin at hematological settings in Greece.
Aims
The aim of the study was to evaluate the efficacy and safety of micafungin administration in standard clinical practice among patients with hematological malignancies, including patients who underwent HSCT .
Methods
This was a multicenter, non interventional, prospective cohort study conducted in 10 research sites in Greece. Adult hospitalized patients with hematological malignancies, including recipients of HSCT, were enrolled in the study between 29 Jun 2013 and 31 Mar 2014. Eligible patients were intended to receive micafungin which was prescribed as per standard clinical practice according to its label, while their assignment to a particular therapeutic strategy was not decided in advance by the protocol. The observational study period lasted until clinical outcome was recorded. Patients were classified according to their clinical presentation at baseline using the revised EORTC criteria (2008).
Results
A total of 143 patients were enrolled. Of them, 122 patients had a hematological malignancy (85.3%), 4 underwent HSCT (2.8%) and 17 had hematological malignancy and HSCT (11.9%). Acute myelogenous leukemia (n=58, 40.6%) was the most common hematological disorder, while just over half of these patients were newly diagnosed (51%). Of the 21 patients in the HSCT group, 12 underwent autologous and 9 allogeneic HSCT. On treatment initiation, 78 patients had fever (54.5%) and 85 patients had neutropenia (59.4%) respectively, while 58 patients had previous febrile episodes( 40.6%). In addition, 112 patients had received systemic antibiotics (78.3%), 64 patients had received corticosteroids ( 44.8%) and 69 patients other immunosuppressive agents (48.3% ) as prior treatment. At baseline, 74 patients of the study received micafungin as prophylaxis while 69 received treatment for possible (52), probable (12) and proven (5) fungal infection.Micafungin was administered as monotherapy in 97.6% of patients and as first line treatment in 75.5% of patients, while the mean duration of micafungin administration was 14.2 days (14.1 days for prophylaxis and 14.3 days for treatment) . The success rates of micafungin were comparable for prophylaxis, possible and proven treatment strategies ( 90.5% vs. 96.2% vs. 100% respectively), while for probable treatment strategy was 75%. It is worth noting that in the latest group, treatment was considered as success in 9 patients, as failure in one patient and in two patients treatment definition as success or failure was not available. Treatment success was defined by the Investigators based on the EORTC/MSG criteria and their judgment as applied for daily clinical decision-making. 26 patients (18.2%) discontinued micafungin mainly due to limited availability of therapy at study sites, patient discharge or safety events not related to the study treatment . In total, 30 adverse events were reported throughout the study, including 8 Serious Adverse Events (deaths) that were not related to micafungin and 22 cases of special situations. One case of lack of efficacy was reported.
Conclusion
Micafungin was effective and well tolerated in patients with hematological malignancies, including patients who underwent HSCT. To this end, micafungin appears to be a valuable treatment option for the management of fungal infections in hematological settings.
Session topic: E-poster
Keyword(s): Fungal infection, Hematological malignancy
Type: Eposter Presentation
Background
Immunocompromised patients, especially those with cancer or underling hematological malignancies and patients who undergo hematopoietic stem cell transplantation (HSCT), are at high risk for invasive fungal infections, which are often life threatening. Echinocandins are recommended as first -line treatment for the management of invasive candidiasis/candidemia from the recent ESCMID guidelines. However, there are relatively limited data for the daily clinical practice regarding the use of micafungin at hematological settings in Greece.
Aims
The aim of the study was to evaluate the efficacy and safety of micafungin administration in standard clinical practice among patients with hematological malignancies, including patients who underwent HSCT .
Methods
This was a multicenter, non interventional, prospective cohort study conducted in 10 research sites in Greece. Adult hospitalized patients with hematological malignancies, including recipients of HSCT, were enrolled in the study between 29 Jun 2013 and 31 Mar 2014. Eligible patients were intended to receive micafungin which was prescribed as per standard clinical practice according to its label, while their assignment to a particular therapeutic strategy was not decided in advance by the protocol. The observational study period lasted until clinical outcome was recorded. Patients were classified according to their clinical presentation at baseline using the revised EORTC criteria (2008).
Results
A total of 143 patients were enrolled. Of them, 122 patients had a hematological malignancy (85.3%), 4 underwent HSCT (2.8%) and 17 had hematological malignancy and HSCT (11.9%). Acute myelogenous leukemia (n=58, 40.6%) was the most common hematological disorder, while just over half of these patients were newly diagnosed (51%). Of the 21 patients in the HSCT group, 12 underwent autologous and 9 allogeneic HSCT. On treatment initiation, 78 patients had fever (54.5%) and 85 patients had neutropenia (59.4%) respectively, while 58 patients had previous febrile episodes( 40.6%). In addition, 112 patients had received systemic antibiotics (78.3%), 64 patients had received corticosteroids ( 44.8%) and 69 patients other immunosuppressive agents (48.3% ) as prior treatment. At baseline, 74 patients of the study received micafungin as prophylaxis while 69 received treatment for possible (52), probable (12) and proven (5) fungal infection.Micafungin was administered as monotherapy in 97.6% of patients and as first line treatment in 75.5% of patients, while the mean duration of micafungin administration was 14.2 days (14.1 days for prophylaxis and 14.3 days for treatment) . The success rates of micafungin were comparable for prophylaxis, possible and proven treatment strategies ( 90.5% vs. 96.2% vs. 100% respectively), while for probable treatment strategy was 75%. It is worth noting that in the latest group, treatment was considered as success in 9 patients, as failure in one patient and in two patients treatment definition as success or failure was not available. Treatment success was defined by the Investigators based on the EORTC/MSG criteria and their judgment as applied for daily clinical decision-making. 26 patients (18.2%) discontinued micafungin mainly due to limited availability of therapy at study sites, patient discharge or safety events not related to the study treatment . In total, 30 adverse events were reported throughout the study, including 8 Serious Adverse Events (deaths) that were not related to micafungin and 22 cases of special situations. One case of lack of efficacy was reported.
Conclusion
Micafungin was effective and well tolerated in patients with hematological malignancies, including patients who underwent HSCT. To this end, micafungin appears to be a valuable treatment option for the management of fungal infections in hematological settings.
Session topic: E-poster
Keyword(s): Fungal infection, Hematological malignancy
Abstract: E1184
Type: Eposter Presentation
Background
Immunocompromised patients, especially those with cancer or underling hematological malignancies and patients who undergo hematopoietic stem cell transplantation (HSCT), are at high risk for invasive fungal infections, which are often life threatening. Echinocandins are recommended as first -line treatment for the management of invasive candidiasis/candidemia from the recent ESCMID guidelines. However, there are relatively limited data for the daily clinical practice regarding the use of micafungin at hematological settings in Greece.
Aims
The aim of the study was to evaluate the efficacy and safety of micafungin administration in standard clinical practice among patients with hematological malignancies, including patients who underwent HSCT .
Methods
This was a multicenter, non interventional, prospective cohort study conducted in 10 research sites in Greece. Adult hospitalized patients with hematological malignancies, including recipients of HSCT, were enrolled in the study between 29 Jun 2013 and 31 Mar 2014. Eligible patients were intended to receive micafungin which was prescribed as per standard clinical practice according to its label, while their assignment to a particular therapeutic strategy was not decided in advance by the protocol. The observational study period lasted until clinical outcome was recorded. Patients were classified according to their clinical presentation at baseline using the revised EORTC criteria (2008).
Results
A total of 143 patients were enrolled. Of them, 122 patients had a hematological malignancy (85.3%), 4 underwent HSCT (2.8%) and 17 had hematological malignancy and HSCT (11.9%). Acute myelogenous leukemia (n=58, 40.6%) was the most common hematological disorder, while just over half of these patients were newly diagnosed (51%). Of the 21 patients in the HSCT group, 12 underwent autologous and 9 allogeneic HSCT. On treatment initiation, 78 patients had fever (54.5%) and 85 patients had neutropenia (59.4%) respectively, while 58 patients had previous febrile episodes( 40.6%). In addition, 112 patients had received systemic antibiotics (78.3%), 64 patients had received corticosteroids ( 44.8%) and 69 patients other immunosuppressive agents (48.3% ) as prior treatment. At baseline, 74 patients of the study received micafungin as prophylaxis while 69 received treatment for possible (52), probable (12) and proven (5) fungal infection.Micafungin was administered as monotherapy in 97.6% of patients and as first line treatment in 75.5% of patients, while the mean duration of micafungin administration was 14.2 days (14.1 days for prophylaxis and 14.3 days for treatment) . The success rates of micafungin were comparable for prophylaxis, possible and proven treatment strategies ( 90.5% vs. 96.2% vs. 100% respectively), while for probable treatment strategy was 75%. It is worth noting that in the latest group, treatment was considered as success in 9 patients, as failure in one patient and in two patients treatment definition as success or failure was not available. Treatment success was defined by the Investigators based on the EORTC/MSG criteria and their judgment as applied for daily clinical decision-making. 26 patients (18.2%) discontinued micafungin mainly due to limited availability of therapy at study sites, patient discharge or safety events not related to the study treatment . In total, 30 adverse events were reported throughout the study, including 8 Serious Adverse Events (deaths) that were not related to micafungin and 22 cases of special situations. One case of lack of efficacy was reported.
Conclusion
Micafungin was effective and well tolerated in patients with hematological malignancies, including patients who underwent HSCT. To this end, micafungin appears to be a valuable treatment option for the management of fungal infections in hematological settings.
Session topic: E-poster
Keyword(s): Fungal infection, Hematological malignancy
Type: Eposter Presentation
Background
Immunocompromised patients, especially those with cancer or underling hematological malignancies and patients who undergo hematopoietic stem cell transplantation (HSCT), are at high risk for invasive fungal infections, which are often life threatening. Echinocandins are recommended as first -line treatment for the management of invasive candidiasis/candidemia from the recent ESCMID guidelines. However, there are relatively limited data for the daily clinical practice regarding the use of micafungin at hematological settings in Greece.
Aims
The aim of the study was to evaluate the efficacy and safety of micafungin administration in standard clinical practice among patients with hematological malignancies, including patients who underwent HSCT .
Methods
This was a multicenter, non interventional, prospective cohort study conducted in 10 research sites in Greece. Adult hospitalized patients with hematological malignancies, including recipients of HSCT, were enrolled in the study between 29 Jun 2013 and 31 Mar 2014. Eligible patients were intended to receive micafungin which was prescribed as per standard clinical practice according to its label, while their assignment to a particular therapeutic strategy was not decided in advance by the protocol. The observational study period lasted until clinical outcome was recorded. Patients were classified according to their clinical presentation at baseline using the revised EORTC criteria (2008).
Results
A total of 143 patients were enrolled. Of them, 122 patients had a hematological malignancy (85.3%), 4 underwent HSCT (2.8%) and 17 had hematological malignancy and HSCT (11.9%). Acute myelogenous leukemia (n=58, 40.6%) was the most common hematological disorder, while just over half of these patients were newly diagnosed (51%). Of the 21 patients in the HSCT group, 12 underwent autologous and 9 allogeneic HSCT. On treatment initiation, 78 patients had fever (54.5%) and 85 patients had neutropenia (59.4%) respectively, while 58 patients had previous febrile episodes( 40.6%). In addition, 112 patients had received systemic antibiotics (78.3%), 64 patients had received corticosteroids ( 44.8%) and 69 patients other immunosuppressive agents (48.3% ) as prior treatment. At baseline, 74 patients of the study received micafungin as prophylaxis while 69 received treatment for possible (52), probable (12) and proven (5) fungal infection.Micafungin was administered as monotherapy in 97.6% of patients and as first line treatment in 75.5% of patients, while the mean duration of micafungin administration was 14.2 days (14.1 days for prophylaxis and 14.3 days for treatment) . The success rates of micafungin were comparable for prophylaxis, possible and proven treatment strategies ( 90.5% vs. 96.2% vs. 100% respectively), while for probable treatment strategy was 75%. It is worth noting that in the latest group, treatment was considered as success in 9 patients, as failure in one patient and in two patients treatment definition as success or failure was not available. Treatment success was defined by the Investigators based on the EORTC/MSG criteria and their judgment as applied for daily clinical decision-making. 26 patients (18.2%) discontinued micafungin mainly due to limited availability of therapy at study sites, patient discharge or safety events not related to the study treatment . In total, 30 adverse events were reported throughout the study, including 8 Serious Adverse Events (deaths) that were not related to micafungin and 22 cases of special situations. One case of lack of efficacy was reported.
Conclusion
Micafungin was effective and well tolerated in patients with hematological malignancies, including patients who underwent HSCT. To this end, micafungin appears to be a valuable treatment option for the management of fungal infections in hematological settings.
Session topic: E-poster
Keyword(s): Fungal infection, Hematological malignancy
{{ help_message }}
{{filter}}