Nicola Gökbuget, Michael Kelsh, Victoria Chia, Anjali Advani, Renato Bassan, Hervè Dombret, Michael Doubek, Adele K. Fielding, Sebastian Giebel, Vincent Haddad, Dieter Hoelzer, Chris Holland, Norbert Ifrah, Aaron Katz, Tapan Maniar, Giovanni Martinelli, Mireia Morgades, Susan O'Brien, Jose-Maria Ribera, Jacob M. Rowe, Anthony S. Stein, Max S. Topp, Martha Wadleigh, Hagop Kantarjian
- 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.
MetadatenAuthor: | Nicola GökbugetGND, Michael Kelsh, Victoria Chia, Anjali Advani, Renato Bassan, Hervè Dombret, Michael Doubek, Adele K. Fielding, Sebastian Giebel, Vincent Haddad, Dieter HoelzerGND, Chris Holland, Norbert Ifrah, Aaron Katz, Tapan Maniar, Giovanni MartinelliORCiD, Mireia Morgades, Susan O'Brien, Jose-Maria Ribera, Jacob M. Rowe, Anthony S. Stein, Max S. Topp, Martha Wadleigh, Hagop KantarjianORCiDGND |
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URN: | urn:nbn:de:hebis:30:3-417262 |
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DOI: | https://doi.org/10.1038/bcj.2016.84 |
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Parent Title (English): | Blood Cancer Journal |
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Document Type: | Article |
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Language: | English |
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Year of Completion: | 2016 |
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Year of first Publication: | 2016 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Release Date: | 2016/11/08 |
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Volume: | 6 |
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Issue: | e473 |
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Page Number: | 7 |
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Note: | 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/ |
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HeBIS-PPN: | 424818787 |
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Institutes: | Medizin / Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Licence (German): | Creative Commons - Namensnennung 4.0 |
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