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dc.contributor.authorSternberg, A.
dc.contributor.authorBoucher, R.
dc.contributor.authorCoulthard, H. C.
dc.contributor.authorRaghavan, M.
dc.contributor.authorCulligan, D.
dc.contributor.authorJackson, A.
dc.contributor.authorCargo, C.
dc.contributor.authorDennis, Michael
dc.contributor.authorMetzner, M.
dc.contributor.authorO'Sullivan, J.
dc.contributor.authorMoore, R.
dc.contributor.authorBowen, D.
dc.contributor.authorVyas, P.
dc.date.accessioned2022-08-31T11:38:31Z
dc.date.available2022-08-31T11:38:31Z
dc.date.issued2022en
dc.identifier.citationSternberg A, Boucher R, Coulthard HC, Raghavan M, Culligan D, Jackson A, et al. Phase Ib study of eltrombopag and azacitidine in patients with high-risk myelodysplastic syndromes and related disorders (the ELASTIC study). British journal of haematology. 2022 Aug 2. PubMed PMID: 35918828. Epub 2022/08/04. eng.en
dc.identifier.pmid35918828en
dc.identifier.doi10.1111/bjh.18389en
dc.identifier.urihttp://hdl.handle.net/10541/625546
dc.description.abstractTreating adverse risk myelodysplastic syndromes with azacitidine exacerbates thrombocytopenia. We report a study of eltrombopag in combination with azacitidine using a 3 + 3 cohort design. Patients with baseline platelets of <150 × 109 /l received eltrombopag ranging from 25 to 300 mg. An 8-day pre-phase of eltrombopag was followed by two cycles of combined therapy. Amongst 31 patients, there were no dose-limiting toxicities. The maximum tolerated dose (MTD) was 300 mg. Transient increases in bone marrow blasts at day 8 were common but no patient had protocol-defined progression following eltrombopag monotherapy. Marrow response rates after three and six treatment cycles were 32% and 29% respectively. In all, 70% of patients treated below and 36% treated at the MTD achieved a modified International Working Group 2006 platelet response at the end of cycle two. Of the platelet transfusion independent patients at baseline, 67% treated at the MTD became transfusion dependent during the first two cycles of treatment. Apart from lack of disease progression, our findings concur with a previously reported Phase III study (A StUdy of eltromboPag in myelodysPlastic SyndrOmes Receiving azaciTidine [SUPPORT]). We conclude that eltrombopag/azacitidine is safe in terms of conventional measures defined by adverse-event reporting. However, in light of SUPPORT and our own descriptive findings regarding efficacy, further combination studies in high-risk disease should be considered with caution.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1111/bjh.18389en
dc.titlePhase Ib study of eltrombopag and azacitidine in patients with high-risk myelodysplastic syndromes and related disorders (the ELASTIC study)en
dc.typeArticleen
dc.contributor.departmentDepartment of Haematology, Great Western Hospital, Swindon, UKen
dc.identifier.journalBritish Journal of Haematologyen
dc.description.noteen]


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