Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL
Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL
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DOI：
10.1182/blood-2012-07-441030
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发表时间：
2012-12-20
期刊：
影响因子：
20.3
通讯作者：
Bargou, Ralf C.
中科院分区：
文献类型：
--
作者：
Topp, Max S.;Goekbuget, Nicola;Bargou, Ralf C.
急性淋巴细胞白血病（ALL）患者化疗后微小残留病（MRD）的持续存在或复发可导致临床复发。在具有持续性或复发性MRD的B系ALL患者的2期试验中，T细胞接合双特异性Ab构建体诱导80%的MRD应答率。在本研究中，我们发现，在中位随访33个月后，整个可评价研究队列的20例患者的血液学无复发生存率为61%（Kaplan-Meier估计）。Blinatumomab治疗后接受异基因造血干细胞移植的9例患者亚组的血液学无复发生存率为65%（Kaplan-Meier估计值）。在6例费城染色体阴性MRD缓解者亚组中，Blinatumomab治疗后未接受进一步治疗，其中4例正在进行血液学和分子学缓解。我们得出的结论是，Blinatumomab可诱导持续性或复发性MRD的B系ALL患者获得长期完全缓解。原始研究和本随访研究分别在www.clinicaltrials.gov注册为NCT 00198991和NCT 00198978。（血。2012; 120（26）：5185-5187）
Persistence or recurrence of minimal residual disease (MRD) after chemotherapy results in clinical relapse in patients with acute lymphoblastic leukemia (ALL). In a phase 2 trial of B-lineage ALL patients with persistent or relapsed MRD, a T cell-engaging bispecific Ab construct induced an 80% MRD response rate. In the present study, we show that after a median follow-up of 33 months, the hematologic relapse-free survival of the entire evaluable study cohort of 20 patients was 61% (Kaplan-Meier estimate). The hematologic relapse-free survival rate of a subgroup of 9 patients who received allogeneic hematopoietic stem cell transplantation after blinatumomab treatment was 65% (Kaplan-Meier estimate). Of the subgroup of 6 Philadelphia chromosome-negative MRD responders with no further therapy after blinatumomab, 4 are in ongoing hematologic and molecular remission. We conclude that blinatumomab can induce long-lasting complete remission in B-lineage ALL patients with persistent or recurrent MRD. The original study and this follow-up study are registered at www.clinicaltrials.gov as NCT00198991 and NCT00198978, respectively. (Blood. 2012; 120(26): 5185-5187)