Universitätsklinikum Würzburg, Würzburg, Germany.
Goethe University, Frankfurt, Germany.
Cancer. 2021 Feb 15;127(4):554-559. doi: 10.1002/cncr.33298. Epub 2020 Nov 3.
BACKGROUND: Blinatumomab is a CD19 BiTE (bispecific T-cell engager) immuno-oncology therapy that mediates the lysis of cells expressing CD19. METHODS: A pooled analysis of long-term follow-up data from 2 phase 2 studies that evaluated blinatumomab in heavily pretreated adults with Philadelphia chromosome-negative, relapsed/refractory B-cell precursor acute lymphoblastic leukemia was conducted. RESULTS: A total of 259 patients were included in the analysis. The median overall survival (OS) among all patients, regardless of response, was 7.5 months (95% confidence interval [CI], 5.5-8.5 months); the median follow-up time for OS was 36.0 months (range, 0.3-60.8 months). The median relapse-free survival (RFS) among patients who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) in the first 2 cycles (n = 123) was 7.7 months (95% CI, 6.2-10.0 months); the median follow-up time for RFS was 35.0 months (range, 9.5-59.5 months). OS and RFS plateaued with 3-year rates of 17.7% and 23.4%, respectively. The cumulative incidence function of the time to relapse, with death not due to relapse considered a competing risk, for patients who achieved a CR/CRh within 2 cycles of treatment also plateaued with a 3-year relapse rate of 59.3%. For patients who achieved a CR/CRh with blinatumomab followed by allogeneic hematopoietic stem cell transplantation while in continuous CR, the median OS was 18.1 months (95% CI, 10.3-30.0 months) with a 3-year survival rate of 37.2%. CONCLUSIONS: These data suggest that long-term survival is possible after blinatumomab therapy. LAY SUMMARY: Immuno-oncology therapies such as blinatumomab activate the patient's own immune system to kill cancer cells. This study combined follow-up data from 2 blinatumomab-related clinical trials to evaluate long-term survival in patients with relapsed and/or refractory B-cell precursor acute lymphoblastic leukemia at high risk for unfavorable outcomes. Among patients who achieved a deep response with blinatumomab, one-third lived 3 years or longer. These findings suggest that long-term survival is possible after treatment with blinatumomab.
背景：blinatumomab 是一种 CD19 BiTE（双特异性 T 细胞衔接器）免疫肿瘤疗法，可介导表达 CD19 的细胞溶解。
方法：对评估blinatumomab 在费城染色体阴性、复发/难治性 B 细胞前体急性淋巴细胞白血病的重度预处理成人中的 2 项 2 期研究的长期随访数据进行了汇总分析。
结果：共有 259 例患者纳入分析。所有患者（无论有无缓解）的中位总生存期（OS）为 7.5 个月（95%置信区间[CI]，5.5-8.5 个月）；OS 的中位随访时间为 36.0 个月（范围，0.3-60.8 个月）。在前 2 个周期中达到完全缓解（CR）或完全缓解伴部分血液学恢复（CRh）的患者（n=123）的中位无进展生存期（RFS）为 7.7 个月（95%CI，6.2-10.0 个月）；RFS 的中位随访时间为 35.0 个月（范围，9.5-59.5 个月）。3 年时 OS 和 RFS 分别稳定在 17.7%和 23.4%。在考虑死亡不是由于复发的竞争风险的情况下，2 个周期内达到 CR/CRh 的患者的复发时间累积发生率函数也趋于平稳，3 年时的复发率为 59.3%。在接受 blinatumomab 治疗并持续处于 CR 的患者中达到 CR/CRh 后进行异基因造血干细胞移植的患者中，中位 OS 为 18.1 个月（95%CI，10.3-30.0 个月），3 年生存率为 37.2%。
结论：这些数据表明，blinatumomab 治疗后可能实现长期生存。
患者教育：免疫肿瘤疗法，如 blinatumomab，可激活患者自身的免疫系统来杀死癌细胞。本研究对两项与 blinatumomab 相关的临床试验的随访数据进行了合并分析，以评估高危复发/难治性 B 细胞前体急性淋巴细胞白血病患者接受 blinatumomab 治疗后的长期生存情况。在接受 blinatumomab 治疗后深度缓解的患者中，有三分之一的患者存活了 3 年或更长时间。这些发现表明，blinatumomab 治疗后可能实现长期生存。
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