Contributions
Abstract: EP491
Type: E-Poster Presentation
Session title: Acute myeloid leukemia - Clinical
Background
CPX-351, a dual-drug liposomal encapsulation of cytarabine and daunorubicin has been approved for the treatment of adults with newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Aims
The primary endpoint of this study was to evaluate the absolute infectious risk in the real-life setting of AML patients (pts) treated with CPX-351. Secondary endpoints were the evaluation of the type, incidence and outcome of infections and to assess the infection-related mortality rate.
Methods
This retrospective, multicentre, observational study includes all consecutive AML pts receiving at least 1 CPX-351 course in 26 Italian hematological centers belonging to the SEIFEM (Sorveglianza Epidemiologica Infezioni nelle Emopatie) group from July 2018 to June 2020.
Results
Overall 152 pts [M/F 77/75; median age 64.5 y.o. (range 49-73)] have been included in this study: 110 with AML-MRC and 42 with t-AML. Overall, 253 courses of CPX-351 had been administered: all 152 pts received first induction course, 12 pts (8%) received second CPX induction, whereas 62 pts (41%) proceeded with the first CPX-351 consolidation course with 27 (43.5%) of them receiving also the second consolidation course.
A total of 179 (71%) febrile events were recorded: 141 (79%) during first or second induction, 25 (14%) and 12 (7%) after first and second consolidation respectively.
After a diagnostic workup in 55 cases (31%) the event has been defined as febrile neutropenia of unknown origin (FUO); the remaining 124 events were classified as microbiologically documented in 99 cases (55%) and clinically documented in 25 cases (14%).
The type of clinically documented infections was 11 pneumonia, 7 cellulitis/ abscesses, 3 arthritis, 2 colitis, 1 sinusitis, 1 cystitis.
Most microbiologically documented infections were of bacterial origin (91/99, 92%) with Gram-positive bacteria detected in 49 cases (54%) and Gram-negative in 42 (46%). Among bacterial infections, sepsis occurred in most cases (80/91) associated with pneumonia in 8 cases; other types of infections were pneumonia (3), abscesses (2), cystitis (4), discitis (1), sinusitis 1.
Overall, a fungal infection due to Aspergillus spp was diagnosed in 9 cases (in 1 case associated with bacterial sepsis) classified as proven 1 case, probable 7 cases, possible 1 case. Sites of aspergillosis were lung in 8 cases and orbital in 1 case.
Only 1 case of CMV reactivation associated with bacterial sepsis occurred.
Stratifying infections according to the treatment phase 141 events (79%) occurred during induction and 38 (21%) during consolidation. Interestingly all Aspergillus infections were diagnosed during the induction phase.
All pts were deeply neutropenic during infections [median duration of neutrophils count< 100 /mL and <500/mL was 12 days (range 1-42) and 16 days (range 2-60) respectively].
The overall 30-days mortality rate was 14% (22/152); most of the deaths (18/22) occurred during the induction phase. Causes of death were infection in 8 pts, AML progression in 8 pts, cerebral hemorrhage 3 pts, cardiac complication 3 pts.
Attributable mortality-infection rate resulted therefore 5.2% (8/152, 7 bacterial and 1 fungal). Notably, all infection-related deaths occurred in pts refractory to CPX-351 treatment.
Conclusion
Our data compared to those of previous registered studies show similar results in terms of infection incidence during CPX-351 induction treatment. Despite prolonged neutropenia infection-related mortality rate resulted relatively low.
Keyword(s): Acute myeloid leukemia, Infection, Therapy-related AML
Abstract: EP491
Type: E-Poster Presentation
Session title: Acute myeloid leukemia - Clinical
Background
CPX-351, a dual-drug liposomal encapsulation of cytarabine and daunorubicin has been approved for the treatment of adults with newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Aims
The primary endpoint of this study was to evaluate the absolute infectious risk in the real-life setting of AML patients (pts) treated with CPX-351. Secondary endpoints were the evaluation of the type, incidence and outcome of infections and to assess the infection-related mortality rate.
Methods
This retrospective, multicentre, observational study includes all consecutive AML pts receiving at least 1 CPX-351 course in 26 Italian hematological centers belonging to the SEIFEM (Sorveglianza Epidemiologica Infezioni nelle Emopatie) group from July 2018 to June 2020.
Results
Overall 152 pts [M/F 77/75; median age 64.5 y.o. (range 49-73)] have been included in this study: 110 with AML-MRC and 42 with t-AML. Overall, 253 courses of CPX-351 had been administered: all 152 pts received first induction course, 12 pts (8%) received second CPX induction, whereas 62 pts (41%) proceeded with the first CPX-351 consolidation course with 27 (43.5%) of them receiving also the second consolidation course.
A total of 179 (71%) febrile events were recorded: 141 (79%) during first or second induction, 25 (14%) and 12 (7%) after first and second consolidation respectively.
After a diagnostic workup in 55 cases (31%) the event has been defined as febrile neutropenia of unknown origin (FUO); the remaining 124 events were classified as microbiologically documented in 99 cases (55%) and clinically documented in 25 cases (14%).
The type of clinically documented infections was 11 pneumonia, 7 cellulitis/ abscesses, 3 arthritis, 2 colitis, 1 sinusitis, 1 cystitis.
Most microbiologically documented infections were of bacterial origin (91/99, 92%) with Gram-positive bacteria detected in 49 cases (54%) and Gram-negative in 42 (46%). Among bacterial infections, sepsis occurred in most cases (80/91) associated with pneumonia in 8 cases; other types of infections were pneumonia (3), abscesses (2), cystitis (4), discitis (1), sinusitis 1.
Overall, a fungal infection due to Aspergillus spp was diagnosed in 9 cases (in 1 case associated with bacterial sepsis) classified as proven 1 case, probable 7 cases, possible 1 case. Sites of aspergillosis were lung in 8 cases and orbital in 1 case.
Only 1 case of CMV reactivation associated with bacterial sepsis occurred.
Stratifying infections according to the treatment phase 141 events (79%) occurred during induction and 38 (21%) during consolidation. Interestingly all Aspergillus infections were diagnosed during the induction phase.
All pts were deeply neutropenic during infections [median duration of neutrophils count< 100 /mL and <500/mL was 12 days (range 1-42) and 16 days (range 2-60) respectively].
The overall 30-days mortality rate was 14% (22/152); most of the deaths (18/22) occurred during the induction phase. Causes of death were infection in 8 pts, AML progression in 8 pts, cerebral hemorrhage 3 pts, cardiac complication 3 pts.
Attributable mortality-infection rate resulted therefore 5.2% (8/152, 7 bacterial and 1 fungal). Notably, all infection-related deaths occurred in pts refractory to CPX-351 treatment.
Conclusion
Our data compared to those of previous registered studies show similar results in terms of infection incidence during CPX-351 induction treatment. Despite prolonged neutropenia infection-related mortality rate resulted relatively low.
Keyword(s): Acute myeloid leukemia, Infection, Therapy-related AML