ERYTHROPOIESIS-STIMULATING AGENTS (ESA) FOR ANEMIA IN MYELOFIBROSIS (MF): A REAL LIFE EXPERIENCE ON 31 UNSELECTED PATIENTS.
(Abstract release date: 05/19/16)
EHA Library. Cerrano M. 06/09/16; 132912; E1363
Dr. Marco Cerrano
Contributions
Contributions
Abstract
Abstract: E1363
Type: Eposter Presentation
Background
Anemia in MF is common but few therapeutic options are available. ESA are safe and widely used but the experience in MF is limited and only a few reports are available.
Aims
We evaluated the safety and efficacy of ESA in MF in a real life context.
Methods
We retrospectively analyzed all the MF patients treated with ESA in our institutions. ESA was started in transfusion-dependent patients or if hemoglobin (Hb) was <10g/dL. According to IWG-MRT and ELN 2013 revised response criteria, anemia response (AR) was defined as a 2 g/dL increase in Hb level for transfusion-independent patients or becoming transfusion-independent for transfusion-dependent patients. The possibility of pretreatment variables to predict a AR to ESA was analyzed using Chi-squared test and Student’s t-test. The duration of response was estimated using the Kaplan-Meier method.
Results
Thirty-one MF patients were treated for anemia with ESA (median age at diagnosis 68 years, range 38-85). MF was primary in 42% of the patients while 26% and 32% of the cases were secondary to polycythemia vera or essential thrombocythemia, respectively. JAK2 mutation was detected in 62% of the patients. Seven patients were transfusion-dependent while in the other group median Hb value was 9.1 g/dL (range 7.9-9.9) at the beginning of ESA treatment. Median time from MF diagnosis to ESA start was 3 months (range 0-89). Fourteen patients received epoetin-alpha (originator product) while 11 cases were treated with epoetin-zeta and 5 with other biosimilar ESA. Median ESA starting dose was 40000 U/weekly (range 8000-40000). One patient received low-dose darbopetin-alpha. Median follow up of living patients after ESA start was 27 months (range 3-80). Globally the AR rate was 52%. Most response occurred in the first 3 months, with a median time to AR of 2 months (range 1-7). Nine patients not responsive to standard-dose ESA increased dose to 80000 U/weekly and 2 of them responded. Two of the 5 patients treated with low-dose ESA (i.e. <20000 U/weekly) responded. Median duration of response was 29 months and the probability of maintaining AR at 12 months was 75%. The elapsed time from MF diagnosis to ESA treatment start was predictive of response to ESA: AR rate among patients who started ESA within 3 months from MF diagnosis was 87% vs 14% in the others, p<0.01. Transfusion-dependent patients showed a trend towards a reduced probability of AR (29% vs 67%, p=0.08). No other predictive factors of response could be found. Among patients with an available baseline serum erythropoietin level (13/31), only 3 showed a value above 125U/L and 1 of them achieved AR after ESA dose increase. Considering the most frequently used types of ESA in our patients, both originator epoetin-alpha and epoetin-zeta obtained favorable results (43% vs 70%, p>0.1).The treatment was well tolerated and no significant adverse events related to ESA were reported. In 5 patients an increase in splenomegaly was recorded during ESA therapy.
Conclusion
Our report confirms the safety and efficacy of ESA for anemia in MF with a fair response duration and it suggests that an early initiation of ESA treatment could yield better results. Besides, we confirm the negative predictive value of transfusion dependence. Epoetin-zeta achieved result at least equal to originator epoetin-alpha, an observation that need to be confirmed but could be important when treatment costs are taken into account.
Session topic: E-poster
Keyword(s): Anemia, Myelofibrosis
Type: Eposter Presentation
Background
Anemia in MF is common but few therapeutic options are available. ESA are safe and widely used but the experience in MF is limited and only a few reports are available.
Aims
We evaluated the safety and efficacy of ESA in MF in a real life context.
Methods
We retrospectively analyzed all the MF patients treated with ESA in our institutions. ESA was started in transfusion-dependent patients or if hemoglobin (Hb) was <10g/dL. According to IWG-MRT and ELN 2013 revised response criteria, anemia response (AR) was defined as a 2 g/dL increase in Hb level for transfusion-independent patients or becoming transfusion-independent for transfusion-dependent patients. The possibility of pretreatment variables to predict a AR to ESA was analyzed using Chi-squared test and Student’s t-test. The duration of response was estimated using the Kaplan-Meier method.
Results
Thirty-one MF patients were treated for anemia with ESA (median age at diagnosis 68 years, range 38-85). MF was primary in 42% of the patients while 26% and 32% of the cases were secondary to polycythemia vera or essential thrombocythemia, respectively. JAK2 mutation was detected in 62% of the patients. Seven patients were transfusion-dependent while in the other group median Hb value was 9.1 g/dL (range 7.9-9.9) at the beginning of ESA treatment. Median time from MF diagnosis to ESA start was 3 months (range 0-89). Fourteen patients received epoetin-alpha (originator product) while 11 cases were treated with epoetin-zeta and 5 with other biosimilar ESA. Median ESA starting dose was 40000 U/weekly (range 8000-40000). One patient received low-dose darbopetin-alpha. Median follow up of living patients after ESA start was 27 months (range 3-80). Globally the AR rate was 52%. Most response occurred in the first 3 months, with a median time to AR of 2 months (range 1-7). Nine patients not responsive to standard-dose ESA increased dose to 80000 U/weekly and 2 of them responded. Two of the 5 patients treated with low-dose ESA (i.e. <20000 U/weekly) responded. Median duration of response was 29 months and the probability of maintaining AR at 12 months was 75%. The elapsed time from MF diagnosis to ESA treatment start was predictive of response to ESA: AR rate among patients who started ESA within 3 months from MF diagnosis was 87% vs 14% in the others, p<0.01. Transfusion-dependent patients showed a trend towards a reduced probability of AR (29% vs 67%, p=0.08). No other predictive factors of response could be found. Among patients with an available baseline serum erythropoietin level (13/31), only 3 showed a value above 125U/L and 1 of them achieved AR after ESA dose increase. Considering the most frequently used types of ESA in our patients, both originator epoetin-alpha and epoetin-zeta obtained favorable results (43% vs 70%, p>0.1).The treatment was well tolerated and no significant adverse events related to ESA were reported. In 5 patients an increase in splenomegaly was recorded during ESA therapy.
Conclusion
Our report confirms the safety and efficacy of ESA for anemia in MF with a fair response duration and it suggests that an early initiation of ESA treatment could yield better results. Besides, we confirm the negative predictive value of transfusion dependence. Epoetin-zeta achieved result at least equal to originator epoetin-alpha, an observation that need to be confirmed but could be important when treatment costs are taken into account.
Session topic: E-poster
Keyword(s): Anemia, Myelofibrosis
Abstract: E1363
Type: Eposter Presentation
Background
Anemia in MF is common but few therapeutic options are available. ESA are safe and widely used but the experience in MF is limited and only a few reports are available.
Aims
We evaluated the safety and efficacy of ESA in MF in a real life context.
Methods
We retrospectively analyzed all the MF patients treated with ESA in our institutions. ESA was started in transfusion-dependent patients or if hemoglobin (Hb) was <10g/dL. According to IWG-MRT and ELN 2013 revised response criteria, anemia response (AR) was defined as a 2 g/dL increase in Hb level for transfusion-independent patients or becoming transfusion-independent for transfusion-dependent patients. The possibility of pretreatment variables to predict a AR to ESA was analyzed using Chi-squared test and Student’s t-test. The duration of response was estimated using the Kaplan-Meier method.
Results
Thirty-one MF patients were treated for anemia with ESA (median age at diagnosis 68 years, range 38-85). MF was primary in 42% of the patients while 26% and 32% of the cases were secondary to polycythemia vera or essential thrombocythemia, respectively. JAK2 mutation was detected in 62% of the patients. Seven patients were transfusion-dependent while in the other group median Hb value was 9.1 g/dL (range 7.9-9.9) at the beginning of ESA treatment. Median time from MF diagnosis to ESA start was 3 months (range 0-89). Fourteen patients received epoetin-alpha (originator product) while 11 cases were treated with epoetin-zeta and 5 with other biosimilar ESA. Median ESA starting dose was 40000 U/weekly (range 8000-40000). One patient received low-dose darbopetin-alpha. Median follow up of living patients after ESA start was 27 months (range 3-80). Globally the AR rate was 52%. Most response occurred in the first 3 months, with a median time to AR of 2 months (range 1-7). Nine patients not responsive to standard-dose ESA increased dose to 80000 U/weekly and 2 of them responded. Two of the 5 patients treated with low-dose ESA (i.e. <20000 U/weekly) responded. Median duration of response was 29 months and the probability of maintaining AR at 12 months was 75%. The elapsed time from MF diagnosis to ESA treatment start was predictive of response to ESA: AR rate among patients who started ESA within 3 months from MF diagnosis was 87% vs 14% in the others, p<0.01. Transfusion-dependent patients showed a trend towards a reduced probability of AR (29% vs 67%, p=0.08). No other predictive factors of response could be found. Among patients with an available baseline serum erythropoietin level (13/31), only 3 showed a value above 125U/L and 1 of them achieved AR after ESA dose increase. Considering the most frequently used types of ESA in our patients, both originator epoetin-alpha and epoetin-zeta obtained favorable results (43% vs 70%, p>0.1).The treatment was well tolerated and no significant adverse events related to ESA were reported. In 5 patients an increase in splenomegaly was recorded during ESA therapy.
Conclusion
Our report confirms the safety and efficacy of ESA for anemia in MF with a fair response duration and it suggests that an early initiation of ESA treatment could yield better results. Besides, we confirm the negative predictive value of transfusion dependence. Epoetin-zeta achieved result at least equal to originator epoetin-alpha, an observation that need to be confirmed but could be important when treatment costs are taken into account.
Session topic: E-poster
Keyword(s): Anemia, Myelofibrosis
Type: Eposter Presentation
Background
Anemia in MF is common but few therapeutic options are available. ESA are safe and widely used but the experience in MF is limited and only a few reports are available.
Aims
We evaluated the safety and efficacy of ESA in MF in a real life context.
Methods
We retrospectively analyzed all the MF patients treated with ESA in our institutions. ESA was started in transfusion-dependent patients or if hemoglobin (Hb) was <10g/dL. According to IWG-MRT and ELN 2013 revised response criteria, anemia response (AR) was defined as a 2 g/dL increase in Hb level for transfusion-independent patients or becoming transfusion-independent for transfusion-dependent patients. The possibility of pretreatment variables to predict a AR to ESA was analyzed using Chi-squared test and Student’s t-test. The duration of response was estimated using the Kaplan-Meier method.
Results
Thirty-one MF patients were treated for anemia with ESA (median age at diagnosis 68 years, range 38-85). MF was primary in 42% of the patients while 26% and 32% of the cases were secondary to polycythemia vera or essential thrombocythemia, respectively. JAK2 mutation was detected in 62% of the patients. Seven patients were transfusion-dependent while in the other group median Hb value was 9.1 g/dL (range 7.9-9.9) at the beginning of ESA treatment. Median time from MF diagnosis to ESA start was 3 months (range 0-89). Fourteen patients received epoetin-alpha (originator product) while 11 cases were treated with epoetin-zeta and 5 with other biosimilar ESA. Median ESA starting dose was 40000 U/weekly (range 8000-40000). One patient received low-dose darbopetin-alpha. Median follow up of living patients after ESA start was 27 months (range 3-80). Globally the AR rate was 52%. Most response occurred in the first 3 months, with a median time to AR of 2 months (range 1-7). Nine patients not responsive to standard-dose ESA increased dose to 80000 U/weekly and 2 of them responded. Two of the 5 patients treated with low-dose ESA (i.e. <20000 U/weekly) responded. Median duration of response was 29 months and the probability of maintaining AR at 12 months was 75%. The elapsed time from MF diagnosis to ESA treatment start was predictive of response to ESA: AR rate among patients who started ESA within 3 months from MF diagnosis was 87% vs 14% in the others, p<0.01. Transfusion-dependent patients showed a trend towards a reduced probability of AR (29% vs 67%, p=0.08). No other predictive factors of response could be found. Among patients with an available baseline serum erythropoietin level (13/31), only 3 showed a value above 125U/L and 1 of them achieved AR after ESA dose increase. Considering the most frequently used types of ESA in our patients, both originator epoetin-alpha and epoetin-zeta obtained favorable results (43% vs 70%, p>0.1).The treatment was well tolerated and no significant adverse events related to ESA were reported. In 5 patients an increase in splenomegaly was recorded during ESA therapy.
Conclusion
Our report confirms the safety and efficacy of ESA for anemia in MF with a fair response duration and it suggests that an early initiation of ESA treatment could yield better results. Besides, we confirm the negative predictive value of transfusion dependence. Epoetin-zeta achieved result at least equal to originator epoetin-alpha, an observation that need to be confirmed but could be important when treatment costs are taken into account.
Session topic: E-poster
Keyword(s): Anemia, Myelofibrosis
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