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well characterized. AVIDA is a longitudinal, multicenter patient registry designed to prospectively collect data from community-based hematology clinics on the natural history and management of patients with MDS and other hematologic disorders, including acute myeloid leukemia, who are treated with azacitidine. We investigated the transfusion independence of patients enrolled in this ongoing registry. Methods: Baseline demographics, disease characteristics, and historical (6 months prior to AVIDA) transfusion requirements were obtained at enrolment. Transfusion requirements and onset of RBC and platelet transfusion independence were recorded. Transfusion independence was defined as no transfusions for at least 56 days. The first day of the 56-day period with no transfusions was noted as the time at which patients first achieved transfusion independence. Results: As of October 8, 2008, 237 (164 males, 73 females) have been enrolled. At baseline, the majority of patients had primary MDS (203 patients; 86%), an Eastern Cooperative Oncology Group performance status of 0 or 1 (184 patients; 78%), and an International Prognostic Scoring System (IPSS) risk classification of Low/Intermediate-1 (151 patients; 64%); 61 (26%) had an Intermediate-2/high IPSS risk and 25 (11%) had unknown IPSS risk. Median time from first MDS diagnosis until azacitidine treatment was 3 months (range, 0 to 148). A total of 923 cycles of azacitidine have been administered; median number of 3 cycles (range, 1−16). The most common dose and schedule was 75mg/m2 (84%) at 5 days on treatment (51%). Transfusion data are available for 139 patients who have received at least 56 days of azacitidine treatment. Forty-two of 78 patients (54%) with a history of RBC transfusion achieved RBC transfusion independence; 36/42 (86%) first achieved RBC transfusion independence during the first 2 cycles. Eleven of 17 patients (65%) with a history of platelet transfusion achieved platelet transfusion independence; 10/11 (91%) first achieved platelet transfusion independence during the first 2 cycles. Azacitidine was generally well tolerated; the most common adverse events were anemia (19%), thrombocytopenia (14%), nausea (13%), constipation (12%), fatigue (11%), and neutropenia (11%). Conclusions: In the community-based setting, patients with MDS can achieve transfusion independence within the first 2 cycles of azacitidine therapy at a rate comparable to that reported in a clinical trial (Aza-001). Full benefit of achieving transfusion independence on quality of life and clinical outcomes will be elucidated as more patients are enrolled. P122 Treatment of CMML by azacytidine (AZA): a preliminary report on 23 patients (pts) |
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