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Azacitidine with or without eltrombopag for first-line treatment of intermediate- or high-risk MDS with thrombocytopenia
Peter MacCallum Canc Ctr, Clin Haematol, Melbourne, Vic 3000, Australia;Univ Melbourne, Sir Peter MacCallum Dept Oncol, Melbourne, Vic, Australia.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Haematology.
Univ Paris XIII, Hop Avicenne, AP HP, Bobigny, France.
Tel Aviv Univ, Tel Aviv Sourasky Med Ctr, Tel Aviv, Israel.
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2018 (English)In: Blood, ISSN 0006-4971, E-ISSN 1528-0020, Vol. 132, no 25, p. 2629-2638Article in journal (Refereed) Published
Abstract [en]

Azacitidine treatment of myelodysplastic syndromes (MDSs) generally exacerbates thrombocytopenia during the first treatment cycles. A Study of Eltrombopag in Myelodysplastic Syndromes Receiving Azacitidine (SUPPORT), a phase 3, randomized, double-blind, placebo-controlled study, investigated the platelet supportive effects of eltrombopag given concomitantly with azacitidine. International Prognostic Scoring System intermediate-1, intermediate-2, or high-risk MDS patients with baseline platelets <75 3 10(9)/L were randomized 1: 1 to eltrombopag (start, 200 mg/d [East Asians, 100 mg/d], maximum, 300 mg/d [East Asians, 150 mg/d]) or placebo, plus azacitidine (75 mg/m2 subcutaneously once daily for 7 days every 28 days). The primary end point was the proportion of patients platelet transfusion-free during cycles 1 through 4 of azacitidine therapy. Based on planned interim analyses, an independent data monitoring committee recommended stopping the study prematurely because efficacy outcomes crossed the predefined futility threshold and for safety reasons. At termination, 28/179 (16%) eltrombopag and 55/177 (31%) placebo patients met the primary end point. Overall response (International Working Group criteria; complete, marrow, or partial response) occurred in 20% and 35% of eltrombopag and placebo patients, respectively, by investigator assessment. There was no difference in hematologic improvement in any cell lineage between the 2 arms. There was no improvement in overall or progression-free survival. Adverse events with >= 10% occurrence in the eltrombopag vs placebo arm were febrile neutropenia and diarrhea. Compared with azacitidine alone, eltrombopag plus azacitidine worsened platelet recovery, with lower response rates and a trend toward increased progression to acute myeloid leukemia. This trial was registered at www.clinicaltrials.govas# NCT02158936.

Place, publisher, year, edition, pages
American Society of Hematology , 2018. Vol. 132, no 25, p. 2629-2638
National Category
Hematology
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URN: urn:nbn:se:uu:diva-373228DOI: 10.1182/blood-2018-06-855221ISI: 000453926500004PubMedID: 30305280OAI: oai:DiVA.org:uu-373228DiVA, id: diva2:1278359
Available from: 2019-01-14 Created: 2019-01-14 Last updated: 2019-11-18Bibliographically approved

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