MULTIDISCIPLINARY EVALUATION AT BASELINE AND DURING TREATMENT IMPROVES THE RATE OF COMPLIANCE AND EFFICACY OF DEFERASIROX IN ELDERLY MYELODYSPLASTIC PATIENTS.
(Abstract release date: 05/19/16)
EHA Library. Del Corso L. 06/09/16; 134814; PB1914
Dr. Lisette Del Corso
Contributions
Contributions
Abstract
Abstract: PB1914
Type: Publication Only
Background
Myelodysplastic syndromes (MDS) are one of the most common hematologic malignancies, the median age at diagnosis is 75 years in most of the series; therefore it can be considered a disease of the elderly patients (pts). Red blood cell transfusion (RBCT) is the main stone of supportive care and a cardinal option to keep patients alive while waiting for effects of specific therapeutic strategies. Transfusion dependency and the consequence iron overload (IOL) has been identified as an independent factor associated with decreased survival. The most important guidelines recommend to start iron chelation therapy (ICT) in all MDS pts with low- and INT1 risk disease with life expectancy >1 year, who have elevated serum ferritin (SF) up to 1000 mcg/L or evidence of iron overload and/or received at least 20 RBCT.
Aims
The aim of the study was to assess the effectiveness of (ICT) in relation of dosing and right management of adverse events (AE) particularly the renal injury. We also evaluate hematological response.
Methods
The safety and the efficacy of DFX were examined in a retrospective multicenter observational study of transfusion MDS patients with International Prognostic Score System (IPSS) low- or INT-1 risk. We included all pts treated with DFX up to 12 months, divided into two groups: the first one (group A) not under multidisciplinary assessment and the second group (group B) with pts under multidisciplinary control by hematologist, Internist, Nephrologist and Immune-hematologist. All pts received DFX at starting dose of 10 mg/kg/day increased up to 30 mg/kg/day according to transfusion regimen, SF, IOL, and tolerance.
Results
We evaluated 44 MDS pts (13 female, 31 male); 26 belonging to the first group and 18 to the second group. The mean age was respectively 74.3±9.0 and 77.9±5.5. The ECOG 0-1 was 84.6% and 83.3%, respectively. The median of RBCT prior starting DFX was 20 (range 3-60) in the first group and 13 (4-150) in second group. The median serum ferritin level at baseline was 1125.5 ng/mL (388-2099) and 1317.0 ng/mL (160-3018), respectively. Serum ferritin level decreased at least of 20% as follows: in 29% of pts of first group and in 31% of second group at 3 months, in 17% and 36%, respectively, at 6 months. At 12 months percentages were 22% and 58%, respectively (p=0.06). The drug related AE was evaluated by the Common Terminology Criteria for Adverse Events (CTCAE version 4.02). The SAE occurred in 11% at 3 months, 29% at 6 months and 16% at 12 months. The most Common AE were diarrhea and serum creatinine increase. The rate of drop out after renal AE was respectively 0% and 10%. The positive hematological response in overall pts was observed in 16% at 6 months and 20% at 6 months.
Conclusion
Un appropriate multidisciplinary assessment of the pre-existing or concomitant comorbidities, the evaluation of the home therapy and of the possible interaction with DFX, a vigilance in co-administration with nephrotoxic drugs may represent strategies to improve the safety and the adherence to ICT and thus the effectiveness. Early starting therapy with DFX at lower doses, maintaining the same dose for the first months avoiding rapid iron depletion, regular clinical and laboratory monitoring appears essential to identify early treatable renal and potentially renal injury avoiding serious adverse effects without necessarily interrupting DFX therapy.
Session topic: E-poster
Keyword(s): Adverse reaction, Deferasirox, Myelodysplasia, Transfusion
Type: Publication Only
Background
Myelodysplastic syndromes (MDS) are one of the most common hematologic malignancies, the median age at diagnosis is 75 years in most of the series; therefore it can be considered a disease of the elderly patients (pts). Red blood cell transfusion (RBCT) is the main stone of supportive care and a cardinal option to keep patients alive while waiting for effects of specific therapeutic strategies. Transfusion dependency and the consequence iron overload (IOL) has been identified as an independent factor associated with decreased survival. The most important guidelines recommend to start iron chelation therapy (ICT) in all MDS pts with low- and INT1 risk disease with life expectancy >1 year, who have elevated serum ferritin (SF) up to 1000 mcg/L or evidence of iron overload and/or received at least 20 RBCT.
Aims
The aim of the study was to assess the effectiveness of (ICT) in relation of dosing and right management of adverse events (AE) particularly the renal injury. We also evaluate hematological response.
Methods
The safety and the efficacy of DFX were examined in a retrospective multicenter observational study of transfusion MDS patients with International Prognostic Score System (IPSS) low- or INT-1 risk. We included all pts treated with DFX up to 12 months, divided into two groups: the first one (group A) not under multidisciplinary assessment and the second group (group B) with pts under multidisciplinary control by hematologist, Internist, Nephrologist and Immune-hematologist. All pts received DFX at starting dose of 10 mg/kg/day increased up to 30 mg/kg/day according to transfusion regimen, SF, IOL, and tolerance.
Results
We evaluated 44 MDS pts (13 female, 31 male); 26 belonging to the first group and 18 to the second group. The mean age was respectively 74.3±9.0 and 77.9±5.5. The ECOG 0-1 was 84.6% and 83.3%, respectively. The median of RBCT prior starting DFX was 20 (range 3-60) in the first group and 13 (4-150) in second group. The median serum ferritin level at baseline was 1125.5 ng/mL (388-2099) and 1317.0 ng/mL (160-3018), respectively. Serum ferritin level decreased at least of 20% as follows: in 29% of pts of first group and in 31% of second group at 3 months, in 17% and 36%, respectively, at 6 months. At 12 months percentages were 22% and 58%, respectively (p=0.06). The drug related AE was evaluated by the Common Terminology Criteria for Adverse Events (CTCAE version 4.02). The SAE occurred in 11% at 3 months, 29% at 6 months and 16% at 12 months. The most Common AE were diarrhea and serum creatinine increase. The rate of drop out after renal AE was respectively 0% and 10%. The positive hematological response in overall pts was observed in 16% at 6 months and 20% at 6 months.
Conclusion
Un appropriate multidisciplinary assessment of the pre-existing or concomitant comorbidities, the evaluation of the home therapy and of the possible interaction with DFX, a vigilance in co-administration with nephrotoxic drugs may represent strategies to improve the safety and the adherence to ICT and thus the effectiveness. Early starting therapy with DFX at lower doses, maintaining the same dose for the first months avoiding rapid iron depletion, regular clinical and laboratory monitoring appears essential to identify early treatable renal and potentially renal injury avoiding serious adverse effects without necessarily interrupting DFX therapy.
Session topic: E-poster
Keyword(s): Adverse reaction, Deferasirox, Myelodysplasia, Transfusion
Abstract: PB1914
Type: Publication Only
Background
Myelodysplastic syndromes (MDS) are one of the most common hematologic malignancies, the median age at diagnosis is 75 years in most of the series; therefore it can be considered a disease of the elderly patients (pts). Red blood cell transfusion (RBCT) is the main stone of supportive care and a cardinal option to keep patients alive while waiting for effects of specific therapeutic strategies. Transfusion dependency and the consequence iron overload (IOL) has been identified as an independent factor associated with decreased survival. The most important guidelines recommend to start iron chelation therapy (ICT) in all MDS pts with low- and INT1 risk disease with life expectancy >1 year, who have elevated serum ferritin (SF) up to 1000 mcg/L or evidence of iron overload and/or received at least 20 RBCT.
Aims
The aim of the study was to assess the effectiveness of (ICT) in relation of dosing and right management of adverse events (AE) particularly the renal injury. We also evaluate hematological response.
Methods
The safety and the efficacy of DFX were examined in a retrospective multicenter observational study of transfusion MDS patients with International Prognostic Score System (IPSS) low- or INT-1 risk. We included all pts treated with DFX up to 12 months, divided into two groups: the first one (group A) not under multidisciplinary assessment and the second group (group B) with pts under multidisciplinary control by hematologist, Internist, Nephrologist and Immune-hematologist. All pts received DFX at starting dose of 10 mg/kg/day increased up to 30 mg/kg/day according to transfusion regimen, SF, IOL, and tolerance.
Results
We evaluated 44 MDS pts (13 female, 31 male); 26 belonging to the first group and 18 to the second group. The mean age was respectively 74.3±9.0 and 77.9±5.5. The ECOG 0-1 was 84.6% and 83.3%, respectively. The median of RBCT prior starting DFX was 20 (range 3-60) in the first group and 13 (4-150) in second group. The median serum ferritin level at baseline was 1125.5 ng/mL (388-2099) and 1317.0 ng/mL (160-3018), respectively. Serum ferritin level decreased at least of 20% as follows: in 29% of pts of first group and in 31% of second group at 3 months, in 17% and 36%, respectively, at 6 months. At 12 months percentages were 22% and 58%, respectively (p=0.06). The drug related AE was evaluated by the Common Terminology Criteria for Adverse Events (CTCAE version 4.02). The SAE occurred in 11% at 3 months, 29% at 6 months and 16% at 12 months. The most Common AE were diarrhea and serum creatinine increase. The rate of drop out after renal AE was respectively 0% and 10%. The positive hematological response in overall pts was observed in 16% at 6 months and 20% at 6 months.
Conclusion
Un appropriate multidisciplinary assessment of the pre-existing or concomitant comorbidities, the evaluation of the home therapy and of the possible interaction with DFX, a vigilance in co-administration with nephrotoxic drugs may represent strategies to improve the safety and the adherence to ICT and thus the effectiveness. Early starting therapy with DFX at lower doses, maintaining the same dose for the first months avoiding rapid iron depletion, regular clinical and laboratory monitoring appears essential to identify early treatable renal and potentially renal injury avoiding serious adverse effects without necessarily interrupting DFX therapy.
Session topic: E-poster
Keyword(s): Adverse reaction, Deferasirox, Myelodysplasia, Transfusion
Type: Publication Only
Background
Myelodysplastic syndromes (MDS) are one of the most common hematologic malignancies, the median age at diagnosis is 75 years in most of the series; therefore it can be considered a disease of the elderly patients (pts). Red blood cell transfusion (RBCT) is the main stone of supportive care and a cardinal option to keep patients alive while waiting for effects of specific therapeutic strategies. Transfusion dependency and the consequence iron overload (IOL) has been identified as an independent factor associated with decreased survival. The most important guidelines recommend to start iron chelation therapy (ICT) in all MDS pts with low- and INT1 risk disease with life expectancy >1 year, who have elevated serum ferritin (SF) up to 1000 mcg/L or evidence of iron overload and/or received at least 20 RBCT.
Aims
The aim of the study was to assess the effectiveness of (ICT) in relation of dosing and right management of adverse events (AE) particularly the renal injury. We also evaluate hematological response.
Methods
The safety and the efficacy of DFX were examined in a retrospective multicenter observational study of transfusion MDS patients with International Prognostic Score System (IPSS) low- or INT-1 risk. We included all pts treated with DFX up to 12 months, divided into two groups: the first one (group A) not under multidisciplinary assessment and the second group (group B) with pts under multidisciplinary control by hematologist, Internist, Nephrologist and Immune-hematologist. All pts received DFX at starting dose of 10 mg/kg/day increased up to 30 mg/kg/day according to transfusion regimen, SF, IOL, and tolerance.
Results
We evaluated 44 MDS pts (13 female, 31 male); 26 belonging to the first group and 18 to the second group. The mean age was respectively 74.3±9.0 and 77.9±5.5. The ECOG 0-1 was 84.6% and 83.3%, respectively. The median of RBCT prior starting DFX was 20 (range 3-60) in the first group and 13 (4-150) in second group. The median serum ferritin level at baseline was 1125.5 ng/mL (388-2099) and 1317.0 ng/mL (160-3018), respectively. Serum ferritin level decreased at least of 20% as follows: in 29% of pts of first group and in 31% of second group at 3 months, in 17% and 36%, respectively, at 6 months. At 12 months percentages were 22% and 58%, respectively (p=0.06). The drug related AE was evaluated by the Common Terminology Criteria for Adverse Events (CTCAE version 4.02). The SAE occurred in 11% at 3 months, 29% at 6 months and 16% at 12 months. The most Common AE were diarrhea and serum creatinine increase. The rate of drop out after renal AE was respectively 0% and 10%. The positive hematological response in overall pts was observed in 16% at 6 months and 20% at 6 months.
Conclusion
Un appropriate multidisciplinary assessment of the pre-existing or concomitant comorbidities, the evaluation of the home therapy and of the possible interaction with DFX, a vigilance in co-administration with nephrotoxic drugs may represent strategies to improve the safety and the adherence to ICT and thus the effectiveness. Early starting therapy with DFX at lower doses, maintaining the same dose for the first months avoiding rapid iron depletion, regular clinical and laboratory monitoring appears essential to identify early treatable renal and potentially renal injury avoiding serious adverse effects without necessarily interrupting DFX therapy.
Session topic: E-poster
Keyword(s): Adverse reaction, Deferasirox, Myelodysplasia, Transfusion
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