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Blinatumomab vs historic standard-of-care treatment for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukaemia
N. Gökbuget, H. Dombret, S. Giebel, M. Brüggemann, M. Doubek, R. Foa, D. Hoelzer, C. Kim, G. Martinelli, E. Parovichnikova, J. Maria Ribera, M. Schoonen, C. Tuglus, G. Zugmaier, R. Bassan,
Jazyk angličtina Země Velká Británie
Typ dokumentu časopisecké články
Grantová podpora
Amgen (Europe) GmBH
Odkazy
PubMed
31876009
DOI
10.1111/ejh.13375
Knihovny.cz E-zdroje
- MeSH
- analýza přežití MeSH
- antitumorózní látky terapeutické užití MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- pre-B-buněčná leukemie farmakoterapie patologie MeSH
- protilátky bispecifické terapeutické užití MeSH
- recidiva MeSH
- reziduální nádor MeSH
- senioři MeSH
- standardní péče * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
OBJECTIVES: Survival outcomes from a single-arm phase 2 blinatumomab study in patients with minimal residual disease (MRD)-positive B-cell precursor (BCP)-acute lymphoblastic leukaemia (ALL) were compared with those receiving standard of care (SOC) in a historic data set. METHODS: The primary analysis comprised adult Philadelphia chromosome (Ph)-negative patients in first complete haematologic remission (MRD ≥ 10-3 ). Relapse-free survival (RFS) and overall survival (OS) were compared between blinatumomab- and SOC-treatment groups. Baseline differences between groups were adjusted by propensity scores. RESULTS: The primary analysis included 73 and 182 patients from the blinatumomab and historic data sets, respectively. When weighted by age to the blinatumomab-treatment group, median RFS was 7.8 months and median OS was 25.9 months in the SOC-treated group. In the blinatumomab study, median RFS was 35.2 months; median OS was not evaluable. Propensity score weighting achieved balance with seven baseline prognostic factors. With adjustment for haematopoietic stem cell transplantation (HSCT) status, a 50% reduction in risk of relapse or death was observed with blinatumomab vs SOC. Median RFS, unadjusted for HSCT status, was 35.2 months with blinatumomab and 8.3 months with SOC. CONCLUSIONS: These analyses suggest that blinatumomab improves RFS, and possibly OS, in adults with MRD-positive Ph-negative BCP-ALL vs SOC.
'Sapienza' University of Rome Rome Italy
Biostatistics Amgen Inc Thousand Oaks CA USA
Center for Observational Research Amgen Inc Thousand Oaks CA USA
Centre for Observational Research Amgen Ltd Uxbridge UK
Clinical Development Amgen GmbH Munich Germany
Hôpital Saint Louis University Paris Diderot Paris France
ICO Hospital Germans Trias i Pujol Jose Carreras Research Institute Barcelona Spain
J W Goethe University Hospital Frankfurt Germany
Maria Sklodowska Curie Institute Oncology Center Gliwice Poland
National Research Center for Hematology Moscow Russia
Policlinico S Orsola Istituto Seragnoli Bologna Italy
University Hospital and CEITEC Masaryk University Brno Czech Republic
University Hospital Goethe University Frankfurt Germany
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- $a OBJECTIVES: Survival outcomes from a single-arm phase 2 blinatumomab study in patients with minimal residual disease (MRD)-positive B-cell precursor (BCP)-acute lymphoblastic leukaemia (ALL) were compared with those receiving standard of care (SOC) in a historic data set. METHODS: The primary analysis comprised adult Philadelphia chromosome (Ph)-negative patients in first complete haematologic remission (MRD ≥ 10-3 ). Relapse-free survival (RFS) and overall survival (OS) were compared between blinatumomab- and SOC-treatment groups. Baseline differences between groups were adjusted by propensity scores. RESULTS: The primary analysis included 73 and 182 patients from the blinatumomab and historic data sets, respectively. When weighted by age to the blinatumomab-treatment group, median RFS was 7.8 months and median OS was 25.9 months in the SOC-treated group. In the blinatumomab study, median RFS was 35.2 months; median OS was not evaluable. Propensity score weighting achieved balance with seven baseline prognostic factors. With adjustment for haematopoietic stem cell transplantation (HSCT) status, a 50% reduction in risk of relapse or death was observed with blinatumomab vs SOC. Median RFS, unadjusted for HSCT status, was 35.2 months with blinatumomab and 8.3 months with SOC. CONCLUSIONS: These analyses suggest that blinatumomab improves RFS, and possibly OS, in adults with MRD-positive Ph-negative BCP-ALL vs SOC.
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