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IRON CHELATION THERAPY IMPROVES HAEMATOLOGICAL RESPONSE IN HIGH-RISK MYELODYSPLASTIC PATIENTS TREATED WITH AZACITIDINE
Author(s):
Salvatore Improta
,
Salvatore Improta
Affiliations:
UOC Ematologia PO Ascalesi ASL Napoli1 Centro,Naples,Italy
Maria Rosaria Villa
,
Maria Rosaria Villa
Affiliations:
UOC Ematologia PO Ascalesi ASL Napoli1 Centro,Naples,Italy
Paola Della Cioppa
,
Paola Della Cioppa
Affiliations:
UOC Ematologia PO Ascalesi ASL Napoli1 Centro,Naples,Italy
Anna Lucania
,
Anna Lucania
Affiliations:
UOC Ematologia PO Ascalesi ASL Napoli1 Centro,Naples,Italy
Mariarosaria Esposito
,
Mariarosaria Esposito
Affiliations:
UOC Ematologia PO Ascalesi ASL Napoli1 Centro,Naples,Italy
Giampiero Nitrato Izzo
,
Giampiero Nitrato Izzo
Affiliations:
UOC Ematologia PO Ascalesi ASL Napoli1 Centro,Naples,Italy
Alfredo Gagliardi
,
Alfredo Gagliardi
Affiliations:
UOC Ematologia PO Ascalesi ASL Napoli1 Centro,Naples,Italy
Lucia Mastrullo
Lucia Mastrullo
Affiliations:
UOC Ematologia PO Ascalesi ASL Napoli1 Centro,Naples,Italy
(Abstract release date: 05/18/17) EHA Library. Improta S. 05/18/17; 182634; PB1920
Salvatore Improta
Salvatore Improta
Contributions
PDF Abstract
Abstract

Abstract: PB1920

Type: Publication Only

Background
The goals of treating older patients with Myelodysplastic Syndrome (MDS) are different than for younger patients. Few elderly patients are able to pursue an allogeneic stem cell transplant. Azacitidine (AZA) improves long-term outcomes of higher-risk MDS patients and is now the reference frontline therapy of higher-risk MDS not eligible for allogeneic stem cell transplant. Anaemia is the most common symptom of MDS and most patients become transfusion-dependent with the risk of iron overload. Deferasirox is an orally available iron chelator administered once-daily in transfusion-dependent patients with various chronic anaemias. Its efficacy has been established in controlled clinical trials.

Aims

We report our experience on using the azacitidine in patients with high-risk MDS, evaluating the efficacy and safety. Concomitant treatment with deferasirox was performed in a routine clinical setting following Consensus Guidelines on Iron Chelation Therapy.

Methods

In our Institution from October 2009 to January 2017 we have treated 32 elderly patients (19 male and 13 female, median age 76 years, r. 71-88) affected by HIGH-RISK MDS (IPSS INT-2/HIGH). Patients received subcutaneous azacitidine at 75mg/m(2) daily for 7 days every 4 weeks. All patients completed at least 6 cycles of therapy. 12/30 (40%) patients underwent more than 8 cycles of therapy. 18/30 patients underwent as well iron chelation therapy with deferasirox receiving a starting dosage of 10 mg/kg/day, subsequently titrated according to serum ferritin (SF) measured monthly.

Results

Complete response (CR), partial response (PR), and hematologic improvement (HI) were observed in 2 (7%), 5 (17%), and 12 (40%) patients, respectively. The median number of cycles to clinical response was 4 (range 4-8). The 2-year rate of acute myeloid leukemia-free survival was 48%. Five serious adverse events occurred in five patients with one fatal outcome. 16 out of 18 patients who showed any hematologic response (CR+PR+HI) meeting International Working Group 2006 criteria had also performed deferasirox therapy. No increased toxicity was noted when deferasirox was used concomitantly with azacitidine.

Conclusion

Our results confirm the effectiveness of the therapy with azacitidine in HIGH-RISK MDS elderly patients with acceptable toxicity profile. Peripheral cytopenias were the most commonly occurring adverse event, with gastrointestinal adverse events and injection-site reactions among the most commonly occurring non-haematological adverse events. In conclusion, azacitidine is an important agent for use in the treatment of elderly patients with MDS. Furthermore concurrent use of deferasirox in patients with iron overload seems to significantly improve the hematologic response by reducing transfusion requirement.

Session topic: 10. Myelodysplastic syndromes - Clinical

Abstract: PB1920

Type: Publication Only

Background
The goals of treating older patients with Myelodysplastic Syndrome (MDS) are different than for younger patients. Few elderly patients are able to pursue an allogeneic stem cell transplant. Azacitidine (AZA) improves long-term outcomes of higher-risk MDS patients and is now the reference frontline therapy of higher-risk MDS not eligible for allogeneic stem cell transplant. Anaemia is the most common symptom of MDS and most patients become transfusion-dependent with the risk of iron overload. Deferasirox is an orally available iron chelator administered once-daily in transfusion-dependent patients with various chronic anaemias. Its efficacy has been established in controlled clinical trials.

Aims

We report our experience on using the azacitidine in patients with high-risk MDS, evaluating the efficacy and safety. Concomitant treatment with deferasirox was performed in a routine clinical setting following Consensus Guidelines on Iron Chelation Therapy.

Methods

In our Institution from October 2009 to January 2017 we have treated 32 elderly patients (19 male and 13 female, median age 76 years, r. 71-88) affected by HIGH-RISK MDS (IPSS INT-2/HIGH). Patients received subcutaneous azacitidine at 75mg/m(2) daily for 7 days every 4 weeks. All patients completed at least 6 cycles of therapy. 12/30 (40%) patients underwent more than 8 cycles of therapy. 18/30 patients underwent as well iron chelation therapy with deferasirox receiving a starting dosage of 10 mg/kg/day, subsequently titrated according to serum ferritin (SF) measured monthly.

Results

Complete response (CR), partial response (PR), and hematologic improvement (HI) were observed in 2 (7%), 5 (17%), and 12 (40%) patients, respectively. The median number of cycles to clinical response was 4 (range 4-8). The 2-year rate of acute myeloid leukemia-free survival was 48%. Five serious adverse events occurred in five patients with one fatal outcome. 16 out of 18 patients who showed any hematologic response (CR+PR+HI) meeting International Working Group 2006 criteria had also performed deferasirox therapy. No increased toxicity was noted when deferasirox was used concomitantly with azacitidine.

Conclusion

Our results confirm the effectiveness of the therapy with azacitidine in HIGH-RISK MDS elderly patients with acceptable toxicity profile. Peripheral cytopenias were the most commonly occurring adverse event, with gastrointestinal adverse events and injection-site reactions among the most commonly occurring non-haematological adverse events. In conclusion, azacitidine is an important agent for use in the treatment of elderly patients with MDS. Furthermore concurrent use of deferasirox in patients with iron overload seems to significantly improve the hematologic response by reducing transfusion requirement.

Session topic: 10. Myelodysplastic syndromes - Clinical

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