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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F16%3A00066726" target="_blank" >RIV/65269705:_____/16:00066726 - isvavai.cz</a>

Výsledek na webu

<a href="http://www.nature.com/bcj/journal/v6/n9/full/bcj201684a.html" target="_blank" >http://www.nature.com/bcj/journal/v6/n9/full/bcj201684a.html</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1038/bcj.2016.84" target="_blank" >10.1038/bcj.2016.84</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FD - Onkologie a hematologie

OECD FORD obor

—

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2016

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Blood cancer journal

ISSN

2044-5385

e-ISSN

—

Svazek periodika

6

Číslo periodika v rámci svazku

Sep

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

7

Strana od-do

"e473"

Kód UT WoS článku

000391802800009

EID výsledku v databázi Scopus

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