Blinatumomab as first salvage versus second or later salvage in adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia: Results of a pooled analysis

被引:15
作者
Topp, Max S. [1 ]
Stein, Anthony S. [2 ]
Goekbuget, Nicola [3 ]
Horst, Heinz-August [4 ]
Boissel, Nicolas [5 ]
Martinelli, Giovanni [6 ]
Kantarjian, Hagop [7 ]
Brueggemann, Monika [8 ]
Chen, Yuqi [9 ]
Zugmaier, Gerhard [10 ]
机构
[1] Univ Klinikum Wurzburg, Med Klin & Poliklin 2, Wurzburg, Germany
[2] City Hope Med Ctr, Gehr Leukemia Ctr, Duarte, CA USA
[3] Univ Klinikum, Med Klin Hamatol Onkol Rheumatol Infektiol 3, Frankfurt, Germany
[4] Univ Klinikum Schleswig Holstein, Klin Innere Med 2, Kiel, Germany
[5] Hop St Louis, Unite Hematol Adolescents & Jeunes Adultes, Paris, France
[6] Ist Sci Romagnolo Studio & Cura Tumori IRST IRCCS, Sci Directorate, Meldola, FC, Italy
[7] Univ Texas MD Anderson Canc Ctr, Dept Leukemia, Houston, TX 77030 USA
[8] Univ Klinikum Schleswig Holstein, Sekt Hamatol Spezialdiagnost, Klin Innere Med 2, Kiel, Germany
[9] Amgen Inc, Global Biostat Sci, Thousand Oaks, CA 91320 USA
[10] Amgen Res Munich GmbH, Global Dev, Munich, Germany
关键词
acute lymphoblastic leukemia; BiTE® blinatumomab; salvage; stem cell transplant;
D O I
10.1002/cam4.3731
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background Blinatumomab is a BiTE(R) immuno-oncology therapy indicated for the treatment of patients with relapsed or refractory (r/r) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL). To assess the efficacy and safety of blinatumomab as first salvage versus second or later salvage in patients with r/r BCP ALL. Patient-level pooled data were used for this analysis. In total, 532 adults with r/r BCP ALL treated with blinatumomab were included (first salvage, n = 165; second or later salvage, n = 367). Compared with patients who received blinatumomab as second or later salvage, those who received blinatumomab as first salvage had a longer median overall survival (OS; 10.4 vs. 5.7 months; HR, 1.58; 95% CI, 1.26-1.97; P < .001) and relapse-free survival (10.1 vs. 7.3 months; HR, 1.38; 95% CI, 0.98-1.93; P = .061), and higher rates of remission (n = 89 [54%] vs. n = 150 [41%]; odds ratio, 0.59; 95% CI, 0.41-0.85; P = .005), minimal residual disease response (n = 68 [41%] vs. n = 118 [32%]), and allogeneic hematopoietic stem cell transplant (alloHSCT) realization (n = 60 [36%] vs. n = 88 [24%]), and alloHSCT in continuous remission (n = 33 [20%] vs. n = 52 (14%]). In a subgroup analysis, there was no apparent effect of prior alloHSCT on median OS in either salvage group. The safety profile of blinatumomab was generally similar between the groups; however, cytokine release syndrome, febrile neutropenia, and infection were more frequent with second or later salvage than with first salvage. In this pooled analysis, the logistic regression analyses indicated greater benefit with blinatumomab as first salvage than as second or later salvage, as evident by the longer median OS, longer median RFS, and higher rates of remission. Overall, blinatumomab was beneficial as first salvage and as second or later salvage, but the effects were favorable as first salvage. Aims Materials & Methods Results Discussion Conclusion
引用
收藏
页码:2601 / 2610
页数:10
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