Blinatumomab vs historic standard-of-care treatment for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukaemia
Por:
Gokbuget, N, Dombret, H, Giebel, S, Bruggemann, M, Doubek, M, Foa, R, Hoelzer, D, Kim, C, Martinelli, G, Parovichnikova, E, Ribera, JM, Schoonen, M, Tuglus, C, Zugmaier, G and Bassan, R
Publicada:
1 abr 2020
Ahead of Print:
1 ene 2020
Resumen:
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.
Filiaciones:
Gokbuget, N:
Goethe Univ, Univ Hosp, Frankfurt, Germany
Dombret, H:
Univ Paris Diderot, Hop St Louis, Paris, France
Giebel, S:
Maria Sklodowska Curie Inst, Oncol Ctr, Gliwice, Poland
Bruggemann, M:
Univ Hosp Schleswig Holstein, Kiel, Germany
Doubek, M:
Univ Hosp, Brno, Czech Republic
Masaryk Univ, CEITEC, Brno, Czech Republic
Foa, R:
Sapienza Univ Rome, Rome, Italy
Hoelzer, D:
JW Goethe Univ Hosp, Frankfurt, Germany
Kim, C:
Amgen Inc, Ctr Observat Res, Thousand Oaks, CA 91320 USA
Martinelli, G:
Policlin S Orsola Ist Seragnoli, Bologna, Italy
Parovichnikova, E:
Natl Res Ctr Hematol, Moscow, Russia
:
Hosp Badalona Germans Trias & Pujol, Jose Carreras Res Inst, ICO, Barcelona, Spain
Schoonen, M:
Amgen Ltd, Ctr Observat Res, Uxbridge, Middx, England
Tuglus, C:
Amgen Inc, Biostat, Thousand Oaks, CA 91320 USA
Zugmaier, G:
Amgen Europe GmbH, Clin Dev, Munich, Germany
Bassan, R:
Osped Angelo, UOC Ematol, Mestre Venezia, Italy
Green Published, hybrid
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