COMPASIVE USE OF 5-AZACITIDINE IN PATIENTS WITH LOW/INT-1 RISK MYELODYSPLASTIC SYNDROMES.
(Abstract release date: 05/19/16)
EHA Library. De Miguel Llorente D. 06/09/16; 134820; PB1920
Dunia De Miguel Llorente
Contributions
Contributions
Abstract
Abstract: PB1920
Type: Publication Only
Background
5-azacitidine (AZA) significantly prolonged overall survival in higher-risk patients with myelodysplastic syndromes (MDS) in international phase III trial (AZA-001). However, data about efficacy of AZA in lower risk MDS are less consistent and only few studies have addressed this topic.
Aims
Evaluate efficacy and security of AZA in low/int-1 risk MDS patients.
Methods
we evaluate the efficacy and safety in low and intermediate-1 risk MDS patients.
Results
In our institution, a total of 59 MDS patients were treated with AZA between 2006 to September 2015. We evaluated 40 patients diagnosed according to WHO criteria as low/intermediate-1 International Prognostic Scoring System (IPSS) risk MDS. At baseline, median age was 75 year old (range 46-90), male/female ratio 26/14. Median time from diagnosis to Aza treatment was 19,8 months (range 1-185). 80,9% patients were transfusion-dependent, 85,7% had received a prior treatment (rhu-EPO+G-CSF 44,4%, only rhu-EPO 55,5%). Low/Int-1 risk patients received AZA dose of 75mg/sqm/d subcutaneously during days 1-7 in a 28-day cycle. The median number of monthly cycles was 11 (range 1-50), and 58% completed at least 6 treatment cycles, respectively.86% patients had a overall response (53% transfusional independence, 23% PR, 10% CR). OS was 44 months.Overall adverse events documented in these patients were neutropenia (33%), anaemia (22%) and thrombocytopenia (17%). Non-hematological adverse events: injection site reaction 39%, 50% constipation, 22% diarrhea and 10% fever.Response duration ranged from 4 to 43 months (median 12 months). 25% patients lost response. There were no significant differences in response rate according to age, previous treatment, transfusion requirements, basal EPO and Hb pre-AZA. 8 patients (13%) were transformed to AML after median 23 months (7-36), Time since AZA treatment 14 months (1-24m).
Conclusion
1.- 86% patients achieved a overall response. 2.- Time to response is early (3 months), although some patients response later (5 cycles or more). 3.- Efficacy and safety of AZA treatment is a valid alternative in low/int-1 risk MDS patients.
Session topic: E-poster
Keyword(s): Hypomethylation
Type: Publication Only
Background
5-azacitidine (AZA) significantly prolonged overall survival in higher-risk patients with myelodysplastic syndromes (MDS) in international phase III trial (AZA-001). However, data about efficacy of AZA in lower risk MDS are less consistent and only few studies have addressed this topic.
Aims
Evaluate efficacy and security of AZA in low/int-1 risk MDS patients.
Methods
we evaluate the efficacy and safety in low and intermediate-1 risk MDS patients.
Results
In our institution, a total of 59 MDS patients were treated with AZA between 2006 to September 2015. We evaluated 40 patients diagnosed according to WHO criteria as low/intermediate-1 International Prognostic Scoring System (IPSS) risk MDS. At baseline, median age was 75 year old (range 46-90), male/female ratio 26/14. Median time from diagnosis to Aza treatment was 19,8 months (range 1-185). 80,9% patients were transfusion-dependent, 85,7% had received a prior treatment (rhu-EPO+G-CSF 44,4%, only rhu-EPO 55,5%). Low/Int-1 risk patients received AZA dose of 75mg/sqm/d subcutaneously during days 1-7 in a 28-day cycle. The median number of monthly cycles was 11 (range 1-50), and 58% completed at least 6 treatment cycles, respectively.86% patients had a overall response (53% transfusional independence, 23% PR, 10% CR). OS was 44 months.Overall adverse events documented in these patients were neutropenia (33%), anaemia (22%) and thrombocytopenia (17%). Non-hematological adverse events: injection site reaction 39%, 50% constipation, 22% diarrhea and 10% fever.Response duration ranged from 4 to 43 months (median 12 months). 25% patients lost response. There were no significant differences in response rate according to age, previous treatment, transfusion requirements, basal EPO and Hb pre-AZA. 8 patients (13%) were transformed to AML after median 23 months (7-36), Time since AZA treatment 14 months (1-24m).
Conclusion
1.- 86% patients achieved a overall response. 2.- Time to response is early (3 months), although some patients response later (5 cycles or more). 3.- Efficacy and safety of AZA treatment is a valid alternative in low/int-1 risk MDS patients.
Session topic: E-poster
Keyword(s): Hypomethylation
Abstract: PB1920
Type: Publication Only
Background
5-azacitidine (AZA) significantly prolonged overall survival in higher-risk patients with myelodysplastic syndromes (MDS) in international phase III trial (AZA-001). However, data about efficacy of AZA in lower risk MDS are less consistent and only few studies have addressed this topic.
Aims
Evaluate efficacy and security of AZA in low/int-1 risk MDS patients.
Methods
we evaluate the efficacy and safety in low and intermediate-1 risk MDS patients.
Results
In our institution, a total of 59 MDS patients were treated with AZA between 2006 to September 2015. We evaluated 40 patients diagnosed according to WHO criteria as low/intermediate-1 International Prognostic Scoring System (IPSS) risk MDS. At baseline, median age was 75 year old (range 46-90), male/female ratio 26/14. Median time from diagnosis to Aza treatment was 19,8 months (range 1-185). 80,9% patients were transfusion-dependent, 85,7% had received a prior treatment (rhu-EPO+G-CSF 44,4%, only rhu-EPO 55,5%). Low/Int-1 risk patients received AZA dose of 75mg/sqm/d subcutaneously during days 1-7 in a 28-day cycle. The median number of monthly cycles was 11 (range 1-50), and 58% completed at least 6 treatment cycles, respectively.86% patients had a overall response (53% transfusional independence, 23% PR, 10% CR). OS was 44 months.Overall adverse events documented in these patients were neutropenia (33%), anaemia (22%) and thrombocytopenia (17%). Non-hematological adverse events: injection site reaction 39%, 50% constipation, 22% diarrhea and 10% fever.Response duration ranged from 4 to 43 months (median 12 months). 25% patients lost response. There were no significant differences in response rate according to age, previous treatment, transfusion requirements, basal EPO and Hb pre-AZA. 8 patients (13%) were transformed to AML after median 23 months (7-36), Time since AZA treatment 14 months (1-24m).
Conclusion
1.- 86% patients achieved a overall response. 2.- Time to response is early (3 months), although some patients response later (5 cycles or more). 3.- Efficacy and safety of AZA treatment is a valid alternative in low/int-1 risk MDS patients.
Session topic: E-poster
Keyword(s): Hypomethylation
Type: Publication Only
Background
5-azacitidine (AZA) significantly prolonged overall survival in higher-risk patients with myelodysplastic syndromes (MDS) in international phase III trial (AZA-001). However, data about efficacy of AZA in lower risk MDS are less consistent and only few studies have addressed this topic.
Aims
Evaluate efficacy and security of AZA in low/int-1 risk MDS patients.
Methods
we evaluate the efficacy and safety in low and intermediate-1 risk MDS patients.
Results
In our institution, a total of 59 MDS patients were treated with AZA between 2006 to September 2015. We evaluated 40 patients diagnosed according to WHO criteria as low/intermediate-1 International Prognostic Scoring System (IPSS) risk MDS. At baseline, median age was 75 year old (range 46-90), male/female ratio 26/14. Median time from diagnosis to Aza treatment was 19,8 months (range 1-185). 80,9% patients were transfusion-dependent, 85,7% had received a prior treatment (rhu-EPO+G-CSF 44,4%, only rhu-EPO 55,5%). Low/Int-1 risk patients received AZA dose of 75mg/sqm/d subcutaneously during days 1-7 in a 28-day cycle. The median number of monthly cycles was 11 (range 1-50), and 58% completed at least 6 treatment cycles, respectively.86% patients had a overall response (53% transfusional independence, 23% PR, 10% CR). OS was 44 months.Overall adverse events documented in these patients were neutropenia (33%), anaemia (22%) and thrombocytopenia (17%). Non-hematological adverse events: injection site reaction 39%, 50% constipation, 22% diarrhea and 10% fever.Response duration ranged from 4 to 43 months (median 12 months). 25% patients lost response. There were no significant differences in response rate according to age, previous treatment, transfusion requirements, basal EPO and Hb pre-AZA. 8 patients (13%) were transformed to AML after median 23 months (7-36), Time since AZA treatment 14 months (1-24m).
Conclusion
1.- 86% patients achieved a overall response. 2.- Time to response is early (3 months), although some patients response later (5 cycles or more). 3.- Efficacy and safety of AZA treatment is a valid alternative in low/int-1 risk MDS patients.
Session topic: E-poster
Keyword(s): Hypomethylation
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