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Título: | 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 |
Autor: | Heuser, Michael; Smith, Douglas; Fiedler, Walter; Sekeres, Mikkael A.; Montesinos, Pau; Leber, Brian; Merchant, Akil; Papayannidis, Cristina; Pérez-Simón, José A. CSIC ORCID; Hoang, Caroline J.; O’Brien, Thomas; Ma, Weidong Wendy; Zeremski, Mirjana; O’Connell, Ashleigh; Chan, Geoffrey; Cortés, Jorge E. | Palabras clave: | Acute myeloid leukemia Clinical trials Glasdegib Secondary acute myeloid leukemi |
Fecha de publicación: | may-2021 | Editor: | Springer Nature | Citación: | Annals of Hematology 100: 1181-1194 (2021) | Resumen: | 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. | Versión del editor: | http://dx.doi.org/10.1007/s00277-021-04465-4 | URI: | http://hdl.handle.net/10261/265444 | DOI: | 10.1007/s00277-021-04465-4 | Identificadores: | doi: 10.1007/s00277-021-04465-4 issn: 0939-5555 e-issn: 1432-0584 |
Referencias: | Heuser, Michael; Smith, Douglas; Fiedler, Walter; Sekeres, Mikkael A.; Montesinos, Pau; Leber, Brian; Merchant, Akil; Papayannidis, Cristina; Pérez-Simón, José A.; Hoang, Caroline J.; O’Brien, Thomas; O’Brien, Thomas; Ma, Weidong Wendy; Zeremski, Mirjana; O’Connell, Ashleigh; Chan, Geoffrey; Cortés, Jorge E. (2021). Correction to: 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: 1917-1918 (2021). http://hdl.handle.net/10261/265477 |
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