dc.creator | Heuser, Michael | es |
dc.creator | Smith, B. Douglas | es |
dc.creator | Fiedler, Walter | es |
dc.creator | Sekeres, Mikkael A. | es |
dc.creator | Montesinos, Pau | es |
dc.creator | Leber, Brian | es |
dc.creator | Pérez Simón, José Antonio | es |
dc.creator | Cortes, Jorge E. | es |
dc.date.accessioned | 2022-10-17T14:12:03Z | |
dc.date.available | 2022-10-17T14:12:03Z | |
dc.date.issued | 2021 | |
dc.identifier.citation | Heuser, M., Smith, B.D., Fiedler, W., Sekeres, M.A., Montesinos, P., Leber, B.,...,Cortes, J.E. (2021). Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial. Annals of Hematology, 100 (5), 1181-1194. https://doi.org/10.1007/s00277-021-04465-4. | |
dc.identifier.issn | 0939-5555 | es |
dc.identifier.issn | 1432-0584 (electrónico) | es |
dc.identifier.uri | https://hdl.handle.net/11441/137966 | |
dc.description.abstract | This analysis from the phase II BRIGHT AML 1003 trial reports the long-term efficacy and safety of glasdegib + low-dose
cytarabine (LDAC) in patients with acute myeloid leukemia ineligible for intensive chemotherapy. The multicenter, open-label
study randomized (2:1) patients to receive glasdegib + LDAC (de novo, n = 38; secondary acute myeloid leukemia, n = 40) or
LDAC alone (de novo, n = 18; secondary acute myeloid leukemia, n = 20). At the time of analysis, 90% of patients had died, with
the longest follow-up since randomization 36 months. The combination of glasdegib and LDAC conferred superior overall
survival (OS) versus LDAC alone; hazard ratio (HR) 0.495; (95% confidence interval [CI] 0.325–0.752); p = 0.0004; median OS
was 8.3 versus 4.3 months. Improvement in OS was consistent across cytogenetic risk groups. In a post-hoc subgroup analysis, a
survival trend with glasdegib + LDAC was observed in patients with de novo acute myeloid leukemia (HR 0.720; 95% CI 0.395–
1.312; p = 0.14; median OS 6.6 vs 4.3 months) and secondary acute myeloid leukemia (HR 0.287; 95% CI 0.151–0.548; p <
0.0001; median OS 9.1 vs 4.1 months). The incidence of adverse events in the glasdegib + LDAC arm decreased after 90 days’
therapy: 83.7% versus 98.7% during the first 90 days. Glasdegib + LDAC versus LDAC alone continued to demonstrate superior
OS in patients with acute myeloid leukemia; the clinical benefit with glasdegib + LDAC was particularly prominent in patients
with secondary acute myeloid leukemia. ClinicalTrials.gov identifier: NCT01546038. | es |
dc.format | application/pdf | es |
dc.format.extent | 14 p. | es |
dc.language.iso | eng | es |
dc.publisher | Springer | es |
dc.relation.ispartof | Annals of Hematology, 100 (5), 1181-1194. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Acute myeloid leukemia | es |
dc.subject | Clinical trial | es |
dc.subject | Glasdegib | es |
dc.subject | Secondary acute myeloid leukemia | es |
dc.title | Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://www.mdpi.com/1660-4601/18/7/3394 | es |
dc.identifier.doi | 10.1007/s00277-021-04465-4 | es |
dc.journaltitle | Annals of Hematology | es |
dc.publication.volumen | 100 | es |
dc.publication.issue | 5 | es |
dc.publication.initialPage | 1181 | es |
dc.publication.endPage | 1194 | es |