Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia

Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia

We compared outcomes from a single-arm study of blinatumomab in adult patients with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia (R/R ALL) with a historical data set from Europe and the United States. Estimates of complete remission (CR) and overall survival (OS) were wei...

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Main Authors: Gökbuget, N, Kelsh, M, Chia, V, Advani, A, Bassan, R, Dombret, H, Doubek, M, Fielding, A K, Giebel, S, Haddad, V, Hoelzer, D, Holland, C, Ifrah, N, Katz, A, Maniar, T, Martinelli, G, Morgades, M, O'Brien, S, Ribera, J-M, Rowe, J M, Stein, A, Topp, M, Wadleigh, M, Kantarjian, H
Format: Online
Language:English
Published: Nature Publishing Group 2016
Online Access:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5056974/
id pubmed-5056974
recordtype oai_dc
spelling pubmed-50569742016-10-24 Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia Gökbuget, N Kelsh, M Chia, V Advani, A Bassan, R Dombret, H Doubek, M Fielding, A K Giebel, S Haddad, V Hoelzer, D Holland, C Ifrah, N Katz, A Maniar, T Martinelli, G Morgades, M O'Brien, S Ribera, J-M Rowe, J M Stein, A Topp, M Wadleigh, M Kantarjian, H Original Article We compared outcomes from a single-arm study of blinatumomab in adult patients with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia (R/R ALL) with a historical data set from Europe and the United States. Estimates of complete remission (CR) and overall survival (OS) were weighted by the frequency distribution of prognostic factors in the blinatumomab trial. Outcomes were also compared between the trial and historical data using propensity score methods. The historical cohort included 694 patients with CR data and 1112 patients with OS data compared with 189 patients with CR and survival data in the blinatumomab trial. The weighted analysis revealed a CR rate of 24% (95% CI: 20–27%) and a median OS of 3.3 months (95% CI: 2.8–3.6) in the historical cohort compared with a CR/CRh rate of 43% (95% CI: 36–50%) and a median OS of 6.1 months (95% CI: 4.2–7.5) in the blinatumomab trial. Propensity score analysis estimated increased odds of CR/CRh (OR=2.68, 95% CI: 1.67–4.31) and improved OS (HR=0.536, 95% CI: 0.394–0.730) with blinatumomab. The analysis demonstrates the application of different study designs and statistical methods to compare novel therapies for R/R ALL with historical data. Nature Publishing Group 2016-09 2016-09-23 /pmc/articles/PMC5056974/ /pubmed/27662202 http://dx.doi.org/10.1038/bcj.2016.84 Text en Copyright © 2016 The Author(s) http://creativecommons.org/licenses/by/4.0/ This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
repository_type Open Access Journal
institution_category Foreign Institution
institution US National Center for Biotechnology Information
building NCBI PubMed
collection Online Access
language English
format Online
author Gökbuget, N
Kelsh, M
Chia, V
Advani, A
Bassan, R
Dombret, H
Doubek, M
Fielding, A K
Giebel, S
Haddad, V
Hoelzer, D
Holland, C
Ifrah, N
Katz, A
Maniar, T
Martinelli, G
Morgades, M
O'Brien, S
Ribera, J-M
Rowe, J M
Stein, A
Topp, M
Wadleigh, M
Kantarjian, H
spellingShingle Gökbuget, N
Kelsh, M
Chia, V
Advani, A
Bassan, R
Dombret, H
Doubek, M
Fielding, A K
Giebel, S
Haddad, V
Hoelzer, D
Holland, C
Ifrah, N
Katz, A
Maniar, T
Martinelli, G
Morgades, M
O'Brien, S
Ribera, J-M
Rowe, J M
Stein, A
Topp, M
Wadleigh, M
Kantarjian, H
Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia
author_facet Gökbuget, N
Kelsh, M
Chia, V
Advani, A
Bassan, R
Dombret, H
Doubek, M
Fielding, A K
Giebel, S
Haddad, V
Hoelzer, D
Holland, C
Ifrah, N
Katz, A
Maniar, T
Martinelli, G
Morgades, M
O'Brien, S
Ribera, J-M
Rowe, J M
Stein, A
Topp, M
Wadleigh, M
Kantarjian, H
author_sort Gökbuget, N
title Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia
title_short Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia
title_full Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia
title_fullStr Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia
title_full_unstemmed Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia
title_sort blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia
description We compared outcomes from a single-arm study of blinatumomab in adult patients with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia (R/R ALL) with a historical data set from Europe and the United States. Estimates of complete remission (CR) and overall survival (OS) were weighted by the frequency distribution of prognostic factors in the blinatumomab trial. Outcomes were also compared between the trial and historical data using propensity score methods. The historical cohort included 694 patients with CR data and 1112 patients with OS data compared with 189 patients with CR and survival data in the blinatumomab trial. The weighted analysis revealed a CR rate of 24% (95% CI: 20–27%) and a median OS of 3.3 months (95% CI: 2.8–3.6) in the historical cohort compared with a CR/CRh rate of 43% (95% CI: 36–50%) and a median OS of 6.1 months (95% CI: 4.2–7.5) in the blinatumomab trial. Propensity score analysis estimated increased odds of CR/CRh (OR=2.68, 95% CI: 1.67–4.31) and improved OS (HR=0.536, 95% CI: 0.394–0.730) with blinatumomab. The analysis demonstrates the application of different study designs and statistical methods to compare novel therapies for R/R ALL with historical data.
publisher Nature Publishing Group
publishDate 2016
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5056974/
_version_ 1613678294312419328

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