Contributions
Abstract: PB2114
Type: Publication Only
Background
Myelodysplastic syndromes (MDS) are a heterogeneous group of neoplastic disorders, with variable clinical course, originated from a clonal disorder of hematopoietic cell. MDS affects most frequently old individuals, who usually have an increased prevalence of comorbidities. In intermediate-2 and high risk myelodysplastic syndromes (MDS), chronic myelomonocitic leukemia (CMML) with 10 - 29 % marrow blasts, and acute myeloid leukemia (20% to 30% marrow blasts) 5-azicitidine induces hematologic responses and prolongs overall survival.
Aims
We retrospectively evaluated the efficacy and tolerability of azacitidine in patients with MDS, CMML and AML in our department of hematology.
Methods
From 2012-2017, 30 patients affected by int-2 and high risk MDS, CMML or AML with marrow blasts < 30%, who were not candidates to aggressive therapy, have been treated with azacitidine at a dosage of 75 mg/m2/d subcutaneously 7 days, every 28 days. The diagnosis was established according to the 2008 WHO criteria, IPSS and WPSS prognostic scores were calculated. The WHO diagnoses were: 20 MDS with IPPS risk int-2 or high, 8 AML with blasts 20-30% and 2 CMML. The median age was 71 (range 45-78), male to female ratio was 0.8 and the median number of cycles received was 7 (range 1-20).
Results
The overall response rate (OPR) was 19/30 patients (59%). According to International Working Group (IWG) 2006 criteria, we detecte complete remission (CR) in eight patients (27%) after a median of 6 cycles (range 6 - 8), hematologic improvement with bone marrow complete remission in four patients (13%) after 8 and 13 cycles of therapy, hematologic improvement in 9 patients (30%) after 6 cycles (range 4-8), stable disease (SD) in 6 patients (20%), and progressive disease (PD) in 3 patients (10%) after 6 cycles (range 4 - 8). Median duration of response was 14 months (range 6 - 28); median overall survival, for all patients treated, from the beginning of azacitidine was 15.2 months (range 8-35). No differeces in response rate could be appreciated according to age, bone marrow fibrosis and transfusion requirements. Among the non-responding patients, five (17%) recquired several admisions to hospital because of infectious or hemorrhagic complications.
Conclusion
Besides a high rate of response (ORR 59%, CR 27%), azacitidine was well tolerated. In particular the low rate of serious adverse events and of hospital admissions despite severe cytopenias, improved quality of life and reduced utilization of standard medical resources. Azacitidine confirmed to be an active therapy in patients not candidate to high intensity treatment for age and/or comorbidities.
Session topic: 10. Myelodysplastic syndromes – Clinical
Abstract: PB2114
Type: Publication Only
Background
Myelodysplastic syndromes (MDS) are a heterogeneous group of neoplastic disorders, with variable clinical course, originated from a clonal disorder of hematopoietic cell. MDS affects most frequently old individuals, who usually have an increased prevalence of comorbidities. In intermediate-2 and high risk myelodysplastic syndromes (MDS), chronic myelomonocitic leukemia (CMML) with 10 - 29 % marrow blasts, and acute myeloid leukemia (20% to 30% marrow blasts) 5-azicitidine induces hematologic responses and prolongs overall survival.
Aims
We retrospectively evaluated the efficacy and tolerability of azacitidine in patients with MDS, CMML and AML in our department of hematology.
Methods
From 2012-2017, 30 patients affected by int-2 and high risk MDS, CMML or AML with marrow blasts < 30%, who were not candidates to aggressive therapy, have been treated with azacitidine at a dosage of 75 mg/m2/d subcutaneously 7 days, every 28 days. The diagnosis was established according to the 2008 WHO criteria, IPSS and WPSS prognostic scores were calculated. The WHO diagnoses were: 20 MDS with IPPS risk int-2 or high, 8 AML with blasts 20-30% and 2 CMML. The median age was 71 (range 45-78), male to female ratio was 0.8 and the median number of cycles received was 7 (range 1-20).
Results
The overall response rate (OPR) was 19/30 patients (59%). According to International Working Group (IWG) 2006 criteria, we detecte complete remission (CR) in eight patients (27%) after a median of 6 cycles (range 6 - 8), hematologic improvement with bone marrow complete remission in four patients (13%) after 8 and 13 cycles of therapy, hematologic improvement in 9 patients (30%) after 6 cycles (range 4-8), stable disease (SD) in 6 patients (20%), and progressive disease (PD) in 3 patients (10%) after 6 cycles (range 4 - 8). Median duration of response was 14 months (range 6 - 28); median overall survival, for all patients treated, from the beginning of azacitidine was 15.2 months (range 8-35). No differeces in response rate could be appreciated according to age, bone marrow fibrosis and transfusion requirements. Among the non-responding patients, five (17%) recquired several admisions to hospital because of infectious or hemorrhagic complications.
Conclusion
Besides a high rate of response (ORR 59%, CR 27%), azacitidine was well tolerated. In particular the low rate of serious adverse events and of hospital admissions despite severe cytopenias, improved quality of life and reduced utilization of standard medical resources. Azacitidine confirmed to be an active therapy in patients not candidate to high intensity treatment for age and/or comorbidities.
Session topic: 10. Myelodysplastic syndromes – Clinical