Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.
Gehr Leukemia Center, City of Hope Medical Center, Duarte, CA, USA.
Cancer Med. 2021 Apr;10(8):2601-2610. doi: 10.1002/cam4.3731. Epub 2021 Mar 18.
Blinatumomab is a BiTE immuno-oncology therapy indicated for the treatment of patients with relapsed or refractory (r/r) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL). Aims To assess the efficacy and safety of blinatumomab as first salvage versus second or later salvage in patients with r/r BCP ALL. Materials & Methods 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). Results 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. Discussion 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. Conclusion Overall, blinatumomab was beneficial as first salvage and as second or later salvage, but the effects were favorable as first salvage.
Blinatumomab 是一种 BiTE 免疫肿瘤疗法，用于治疗复发或难治性 (r/r) B 细胞前体 (BCP) 急性淋巴细胞白血病 (ALL) 患者。目的 评估blinatumomab 作为一线挽救治疗与二线或更后线挽救治疗在 r/r BCP ALL 患者中的疗效和安全性。材料与方法 本分析采用患者水平的汇总数据。共纳入 532 例接受blinatumomab 治疗的 r/r BCP ALL 成年患者（一线挽救治疗 n = 165；二线或更后线挽救治疗 n = 367）。结果 与接受二线或更后线挽救治疗的患者相比，接受一线挽救治疗的患者中位总生存期 (OS；10.4 个月 vs. 5.7 个月；HR，1.58；95%CI，1.26-1.97；P <.001) 和无疾病复发生存期 (RFS；10.1 个月 vs. 7.3 个月；HR，1.38；95%CI，0.98-1.93；P =.061) 更长，缓解率更高（n = 89 [54%] vs. n = 150 [41%]；比值比，0.59；95%CI，0.41-0.85；P =.005），微小残留病灶缓解率更高（n = 68 [41%] vs. n = 118 [32%]），以及接受同种异体造血干细胞移植 (alloHSCT) 的比例更高（n = 60 [36%] vs. n = 88 [24%]），以及持续缓解状态下接受 alloHSCT 的比例更高（n = 33 [20%] vs. n = 52 [14%]）。亚组分析显示，在两组挽救治疗中，既往 alloHSCT 对中位 OS 均无明显影响。两组的安全性谱总体相似；然而，与一线挽救治疗相比，二线或更后线挽救治疗中细胞因子释放综合征、发热性中性粒细胞减少症和感染更为常见。讨论 在本汇总分析中，逻辑回归分析表明，blinatumomab 作为一线挽救治疗比作为二线或更后线挽救治疗更有益，表现为中位 OS 更长、中位 RFS 更长以及缓解率更高。结论 总体而言，blinatumomab 作为一线和二线或更后线挽救治疗均有益，但一线挽救治疗的效果更优。
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