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Blinatumomab compared with standard of care for the treatment of adult patients with relapsed/refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia
Rambaldi, Alessandro (Department of Oncology and Hematology. University of Milan)
Ribera, Jose-Maria (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Kantarjian, H. M. (Department of Leukemia. University of Texas MD Anderson Cancer Center)
Dombret, Hervé (Department of Hematology. Hopital Saint-Louis. Paris Diderot University)
Ottmann, O. G. (Division of Cancer and Genetics. School of Medicine. Cardiff University)
Stein, A. S. (Gehr Family Center for Leukemia Research. City of Hope)
Tuglus, C. A. (Amgen. Inc)
Zhao, X. (Amgen. Inc)
Kim, C. (Amgen. Inc)
Martinelli, Giovanni (Scientific Institute of Romagna for the Study and Treatment of Cancer)
Universitat Autònoma de Barcelona

Fecha: 2020
Resumen: Background: A single-arm, phase 2 trial demonstrated the efficacy and safety of blinatumomab, a bispecific T-cell-engaging antibody construct, in patients with relapsed/refractory (r/r) Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), a rare hematologic malignancy with limited treatment options. This study compared outcomes with blinatumomab with those of a historical control treated with the standard of care (SOC). Methods: The blinatumomab trial enrolled adult patients with Ph+ ALL who were r/r to at least 1 second-generation tyrosine kinase inhibitor (n = 45). Propensity score analysis (PSA) was used to compare outcomes with blinatumomab with those of an external cohort of similar patients receiving SOC chemotherapy (n = 55). The PSA mitigated confounding variables between studies by adjusting for imbalances in the age at diagnosis and start of treatment, sex, duration from diagnosis to most recent treatment, prior allogeneic hematopoietic stem cell transplantation, prior salvage therapy, and number of salvage therapies. Bayesian data augmentation was applied to improve power to 80% with data from a phase 3 blinatumomab study in r/r Philadelphia chromosome-negative ALL. Results: In the PSA, the rate of complete remission or complete remission with partial hematologic recovery was 36% for blinatumomab and 25% for SOC, and this resulted in an odds ratio of 1. 54 (95% confidence interval [CI], 0. 61-3. 89) or 1. 70 (95% credible interval [CrI], 0. 94-2. 94) with Bayesian data augmentation. Overall survival favored blinatumomab over SOC, with a hazard ratio of 0. 81 (95% CI, 0. 57-1. 14) or 0. 77 (95% CrI, 0. 61-0. 96) with Bayesian data augmentation. Conclusions: These results further support blinatumomab as a treatment option for patients with r/r Ph+ ALL.
Derechos: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades. Creative Commons
Lengua: Anglès
Documento: Article ; recerca ; Versió publicada
Materia: Philadelphia chromosome-positive acute lymphoblastic leukemia ; Blinatumomab ; Propensity score analysis ; Remission ; Standard of care ; Survival
Publicado en: Cancer, Vol. 126 Núm. 2 (15 2020) , p. 304-310, ISSN 1097-0142

DOI: 10.1002/cncr.32558
PMID: 31626339


7 p, 171.0 KB

El registro aparece en las colecciones:
Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Artículos > Artículos de investigación
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 Registro creado el 2021-02-02, última modificación el 2023-02-28



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