GOKBUGET, N., H. DOMBRET, S. GIEBEL, M. BRUGGEMANN, Michael DOUBEK, R. FOA, D. HOELZER, C. KIM, G. MARTINELLI, E. PAROVICHNIKOVA, J.M. RIBERA, M. SCHOONEN, C. TUGLUS, G. ZUGMAIER and R. BASSAN. Blinatumomab vs historic standard-of-care treatment for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukaemia. European Journal of Haematology. Hoboken: Wiley-Blackwell, 2020, vol. 104, No 4, p. 299-309. ISSN 0902-4441. Available from: https://dx.doi.org/10.1111/ejh.13375.
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Basic information
Original name Blinatumomab vs historic standard-of-care treatment for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukaemia
Authors GOKBUGET, N., H. DOMBRET, S. GIEBEL, M. BRUGGEMANN, Michael DOUBEK (203 Czech Republic, guarantor, belonging to the institution), R. FOA, D. HOELZER, C. KIM, G. MARTINELLI, E. PAROVICHNIKOVA, J.M. RIBERA, M. SCHOONEN, C. TUGLUS, G. ZUGMAIER and R. BASSAN.
Edition European Journal of Haematology, Hoboken, Wiley-Blackwell, 2020, 0902-4441.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30205 Hematology
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 2.997
RIV identification code RIV/00216224:14740/20:00116120
Organization unit Central European Institute of Technology
Doi http://dx.doi.org/10.1111/ejh.13375
UT WoS 000509095600001
Keywords in English acute lymphoblastic leukaemia; clinical trials
Tags rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Pavla Foltynová, Ph.D., učo 106624. Changed: 11/3/2021 17:38.
Abstract
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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