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Survival outcomes and clinical benefit in patients with acute myeloid leukemia treated with glasdegib and low-dose cytarabine according to response to therapy.
Cortes, Jorge E; Heidel, Florian H; Fiedler, Walter; Smith, B Douglas; Robak, Tadeusz; Montesinos, Pau; Candoni, Anna; Leber, Brian; Sekeres, Mikkael A; Pollyea, Daniel A; Ferdinand, Roxanne; Ma, Weidong Wendy; O'Brien, Thomas; O'Connell, Ashleigh; Chan, Geoffrey; Heuser, Michael.
Afiliación
  • Cortes JE; Georgia Cancer Center, Augusta, CA, USA. jorge.cortes@augusta.edu.
  • Heidel FH; Otto-von-Guericke University Medical Center Magdeburg, Magdeburg, Germany.
  • Fiedler W; Internal Medicine II, University Hospital Jena, Jena, Germany.
  • Smith BD; Department of Hematology and Oncology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
  • Robak T; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
  • Montesinos P; Department of Hematology, Medical University of Lódz and Copernicus Memorial Hospital, Lódz, Poland.
  • Candoni A; Hospital Universitari i Politècnic La Fe, Valencia, Spain; CIBERONC, Instituto Carlos III, Madrid, Spain.
  • Leber B; Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy.
  • Sekeres MA; Juravinski Hospital at Hamilton Health Sciences, Hamilton, ON, Canada.
  • Pollyea DA; Leukemia Program, Cleveland Clinic, Cleveland, OH, USA.
  • Ferdinand R; Division of Hematology, University of Colorado School of Medicine, Aurora, CO, USA.
  • Ma WW; Pfizer Oncology, New York, NY, USA.
  • O'Brien T; Pfizer Oncology, New York, NY, USA.
  • O'Connell A; Pfizer Oncology, New York, NY, USA.
  • Chan G; Pfizer Oncology, New York, NY, USA.
  • Heuser M; Pfizer Oncology, New York, NY, USA.
J Hematol Oncol ; 13(1): 92, 2020 07 14.
Article en En | MEDLINE | ID: mdl-32664995
BACKGROUND: The phase 2 BRIGHT AML 1003 trial evaluated 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 patients to receive glasdegib + LDAC (n = 78) or LDAC alone (n = 38). The rate of complete remission (CR) was 19.2% in the glasdegib + LDAC arm versus 2.6% in the LDAC arm (P = 0.015). METHODS: This post hoc analysis determines whether the clinical benefits of glasdegib are restricted to patients who achieve CR, or if they extend to those who do not achieve CR. RESULTS: In patients who did not achieve CR, the addition of glasdegib to LDAC improved overall survival (OS) versus LDAC alone (hazard ratio = 0.63 [95% confidence interval, 0.41-0.98]; P = 0.0182; median OS, 5.0 vs 4.1 months). Additionally, more patients receiving glasdegib + LDAC achieved durable recovery of absolute neutrophil count (≥ 1000/µl, 45.6% vs 35.5%), hemoglobin (≥ 9 g/dl, 54.4% vs 38.7%), and platelets (≥ 100,000/µl, 29.8% vs 9.7%). Transfusion independence was achieved by 15.0% and 2.9% of patients receiving glasdegib + LDAC and LDAC alone, respectively. CONCLUSIONS: Collectively, these data suggest that there are clinical benefits with glasdegib in the absence of CR. TRIAL REGISTRATION: ClinicalTrials.gov NCT01546038 (March 7, 2012).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Leucemia Mieloide Aguda / Protocolos de Quimioterapia Combinada Antineoplásica Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: J Hematol Oncol Asunto de la revista: HEMATOLOGIA / NEOPLASIAS Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Leucemia Mieloide Aguda / Protocolos de Quimioterapia Combinada Antineoplásica Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: J Hematol Oncol Asunto de la revista: HEMATOLOGIA / NEOPLASIAS Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido