6564 Background: Patients (pts) with myelodysplastic syndrome (MDS) disorders often develop anemia, resulting in increased transfusions and fatigue. Using the erythropoiesis-stimulating agent (ESA) epoetin alfa to treat anemia in low-risk MDS pts results in an average response rate of 30% (40% when used with G-CSF). Pilot studies suggest that 150 or 300 mcg/week (wk) darbepoetin alfa (DA) can raise hemoglobin (Hb) levels in anemic MDS pts. Methods: This fully enrolled (n = 209), phase 2, single-arm, 52-wk ongoing study is examining DA 500 mcg every 3 weeks (Q3W) for treating anemic pts (Hb ≤ 11 g/dL) with low- or intermediate-risk MDS (IPSS definition). The study’s primary endpoint is the proportion of pts achieving an erythroid response by 13 wks. Other endpoints include the proportion of pts achieving an erythroid response by 27/28 wks and change in both Hb levels and FACT-F scores. Results are stratified by whether pts received ESA therapy before enrollment: ESA-naïve (ESA-N) vs ESA-treated (ESA-T). Results: Previous interim data suggested that low-risk MDS pts can achieve a major erythroid response after 13 wks of DA 500 mcg Q3W. This is the first reported summary of results from a planned interim analysis after 27/28 wks of treatment (n = 129). Of 84 ESA-N pts, 51% were men, 86% were white, and the average (SD) age was 74.1 (9.7) years; the 45 ESA-T pts had similar demographics. During 27/28 wks of treatment, a majority of pts achieved a major erythroid response. ESA-N pts had a mean (SD) 1.2 (1.4) g/dL rise in Hb levels from BL and a clinically significant increase in FACT-F score from BL ( Table ). Of the 129 pts analyzed after 27/28 wks, 83% reported an adverse event (AE) and none reported serious treatment-related AEs or thrombotic events (of 189 pts analyzed after 13 wks, 1 pt reported a serious treatment-related AE). Conclusions: These interim results suggest that DA 500 mcg Q3W is well tolerated and can raise Hb levels in anemic, low-risk MDS pts. Final 27/28-wk data from all enrolled pts (n = 209) will be shown. [Table: see text] [Table: see text]
Withdrawal of inhaled corticosteroids can be safe in COPD patients at low risk of exacerbation: a real-life study on the appropriateness of treatment in moderate COPD patients (OPTIMO)