UO Ematologia
Contributions
Type: Publication Only
Background
Erytropoietin (EPO) is a valuable option in the treatment of low risk myelodisplastic syndrome (MDS).
Since the expiration of EPO alpha patent, epoietin biosimilars are becoming an increasingly important therapeutic option as anti-anemic drugs.
Clinical efficacy and safety of biosimilar EPOs have been demonstrated in renal failure and chemotherapy anemias, but not in the treatment of myelodisplasic syndrome (MDS) patients.
Aims
Our study was designed to evaluate safety and efficacy of erythropoietin zeta (Retacrit, Hospira), a biosimilar of EPO alpha, to treat anemia of low risk MDS, such as low and Intermediate-1 (Int-1) patients according to International Prognostic Scoring System (IPSS ).
Methods
We collected data from 32 MDS patients (14 males, 18 females), aged 58-84 (median 76.5), treated with EPO zeta in Sicily. According to WHO classification, 15 out of 32 subjects were diagnosed as refractory anemias (RA), 13/32 as refractory cytopenias with multilineage dysplasia (RCMD) and 4/32 as refractory anemias with excess blasts-1 (RAEB-1, bone marrow blasts <10%). Considering cytogenetic subgroups, karyotype was favourable in 28 out of 32 patients while was intermediate in the remaining 4. According to IPSS risk stratification, 17/32 patients were classified in the low risk group and 15/32 in the Int-1. Four patients were transfusion dependent before anti-anemia treatment with EPO.
To start EPO treatment: 1) Emoglobin (Hb) had to be below 10 g/dl; 2) Serum iron, folate and B12 vitamin had to be in the in the normal range or corrected before therapy onset; 3) the maximum allowed transfusional need was of 3 units of packed red blood cells (PRBC) per month in the 90 preceding days; 4) serum EPO levels had to be below 500 UI/ml.
Patients were treated with EPO zeta, 40.000 U s.c./week. After 8 weeks, whether there was no or suboptimal response (raise in Hb of less than 1.5 g/dl and/or no transfusion independence), EPO dose was raised to 80.000 U s.c./week. Treatment was continued for 24 weeks.
Results
Patients were considered as responders either when Hb levels raised of at least 1.5 g/dl from basal levels (and this data had to be confirmed in two consecutive evaluations) or when there was at least a 50% reduction of the trasfusional needs as evaluated before starting EPO.
Responders were 23 out of 32 patients (71.9%); for 9/23 responders (39%) EPO dose had to be raised to 80.000 U/week to obtain the best results.
No side effects greater than G1 according to WHO were reported in our cohort of patients during the 24 weeks treatment period.
Summary
In our series, efficacy of EPO zeta in low risk MDS patients was consistent with that reported in the literature using the originator EPO alpha in similar patient populations. Larger prospective randomized studies comparing originator and biosimilar EPOs will provide a definitive answer. However, biosimilar EPO zeta seems to be a good option to treat anemia in low risk MDS, thus saving resources considered its favourable pharmaco-economic profile.
Keyword(s): EPO, Epoetin alfa, MDS, Myelodysplasia
Session topic: Publication Only
Type: Publication Only
Background
Erytropoietin (EPO) is a valuable option in the treatment of low risk myelodisplastic syndrome (MDS).
Since the expiration of EPO alpha patent, epoietin biosimilars are becoming an increasingly important therapeutic option as anti-anemic drugs.
Clinical efficacy and safety of biosimilar EPOs have been demonstrated in renal failure and chemotherapy anemias, but not in the treatment of myelodisplasic syndrome (MDS) patients.
Aims
Our study was designed to evaluate safety and efficacy of erythropoietin zeta (Retacrit, Hospira), a biosimilar of EPO alpha, to treat anemia of low risk MDS, such as low and Intermediate-1 (Int-1) patients according to International Prognostic Scoring System (IPSS ).
Methods
We collected data from 32 MDS patients (14 males, 18 females), aged 58-84 (median 76.5), treated with EPO zeta in Sicily. According to WHO classification, 15 out of 32 subjects were diagnosed as refractory anemias (RA), 13/32 as refractory cytopenias with multilineage dysplasia (RCMD) and 4/32 as refractory anemias with excess blasts-1 (RAEB-1, bone marrow blasts <10%). Considering cytogenetic subgroups, karyotype was favourable in 28 out of 32 patients while was intermediate in the remaining 4. According to IPSS risk stratification, 17/32 patients were classified in the low risk group and 15/32 in the Int-1. Four patients were transfusion dependent before anti-anemia treatment with EPO.
To start EPO treatment: 1) Emoglobin (Hb) had to be below 10 g/dl; 2) Serum iron, folate and B12 vitamin had to be in the in the normal range or corrected before therapy onset; 3) the maximum allowed transfusional need was of 3 units of packed red blood cells (PRBC) per month in the 90 preceding days; 4) serum EPO levels had to be below 500 UI/ml.
Patients were treated with EPO zeta, 40.000 U s.c./week. After 8 weeks, whether there was no or suboptimal response (raise in Hb of less than 1.5 g/dl and/or no transfusion independence), EPO dose was raised to 80.000 U s.c./week. Treatment was continued for 24 weeks.
Results
Patients were considered as responders either when Hb levels raised of at least 1.5 g/dl from basal levels (and this data had to be confirmed in two consecutive evaluations) or when there was at least a 50% reduction of the trasfusional needs as evaluated before starting EPO.
Responders were 23 out of 32 patients (71.9%); for 9/23 responders (39%) EPO dose had to be raised to 80.000 U/week to obtain the best results.
No side effects greater than G1 according to WHO were reported in our cohort of patients during the 24 weeks treatment period.
Summary
In our series, efficacy of EPO zeta in low risk MDS patients was consistent with that reported in the literature using the originator EPO alpha in similar patient populations. Larger prospective randomized studies comparing originator and biosimilar EPOs will provide a definitive answer. However, biosimilar EPO zeta seems to be a good option to treat anemia in low risk MDS, thus saving resources considered its favourable pharmaco-economic profile.
Keyword(s): EPO, Epoetin alfa, MDS, Myelodysplasia
Session topic: Publication Only