Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Sep 23;6(9):e473.
doi: 10.1038/bcj.2016.84.

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

N Gökbuget  1 , M Kelsh  2 , V Chia  2 , A Advani  3 , R Bassan  4 , H Dombret  5 , M Doubek  6 , A K Fielding  7 , S Giebel  8 , V Haddad  9 , D Hoelzer  1 , C Holland  10 , N Ifrah  11 , A Katz  2 , T Maniar  12 , G Martinelli  13 , M Morgades  14 , S O'Brien  15 , J-M Ribera  14 , J M Rowe  16 , A Stein  17 , M Topp  18 , M Wadleigh  19 , H Kantarjian  15
Affiliations

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

N Gökbuget et al. Blood Cancer J. .

Abstract

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.

PubMed Disclaimer

Conflict of interest statement

NG and J-MR have received research support and honoraria from Pfizer and Amgen. AA has received research support from Pfizer and Amgen and honoraria from Pfizer. RB and SG have received honoraria from Amgen. AS has served on speakers' bureau and advisory boards for Amgen. VC, AK, MK and JS are employees and shareholders of Amgen; VH and TM were employees of Amgen when the study was conducted. The remaining authors declare no competing interests.

Figures

Figure 1
Figure 1
Historical database analysis cohort.
Figure 2
Figure 2
Comparison of complete response and overall survival between blinatumomab clinical trial patients and historical patients. Outcomes were analyzed using both the IPTW and sIPTW approaches: Odds ratio (OR) for achieving a CR/CRh (blinatumomab patients) or CR (historical patients) and hazard ratio (HR) for overall survival.
See this image and copyright information in PMC

Comment in

References

    1. Katz AJ, Chia VM, Schoonen WM, Kelsh MA. Acute lymphoblastic leukemia: an assessment of international incidence, survival, and disease burden. Cancer Causes Control 2015; 26: 1627–1642. - PubMed
    1. Bassan R, Hoelzer D. Modern therapy of acute lymphoblastic leukemia. J Clin Oncol 2011; 29: 532–543. - PubMed
    1. Fielding AK, Richards SM, Chopra R, Lazarus HM, Litzow MR, Buck G et al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood 2007; 109: 944–950. - PubMed
    1. Tavernier E, Boiron JM, Huguet F, Bradstock K, Vey N, Kovacsovics T et al. Outcome of treatment after first relapse in adults with acute lymphoblastic leukemia initially treated by the LALA-94 trial. Leukemia 2007; 21: 1907–1914. - PubMed
    1. O'Brien S, Thomas D, Ravandi F, Faderl S, Cortes J, Borthakur G et al. Outcome of adults with acute lymphocytic leukemia after second salvage therapy. Cancer 2008; 113: 3186–3191. - PMC - PubMed