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首页> 外文期刊>Leukemia Research: A Forum for Studies on Leukemia and Normal Hemopoiesis >Impact of minimal residual disease status in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial
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Impact of minimal residual disease status in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial

机译：在III in Ino-Vate试验中，在Inotuzumab ozogamicin治疗复发/难治性急性淋巴细胞白血病患者中的影响

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摘要

Minimal residual disease (MRD) negativity is a key prognostic indicator of outcome in acute lymphocytic leukemia. In the INO-VATE trial (clinicaltrials.gov identifier: NCT01564784), patients with relapsed/refractory acute lymphocytic leukemia who received inotuzumab versus standard chemotherapy achieved greater remission and MRD-negativity rates as well as improved overall survival: hazard ratio 0.75, one-sided P = 0.0105. The current analysis assessed the prognostic value of MRD negativity at the end of inotuzumab treatment. All patients who received inotuzumab (n = 164) were included. Among patients with complete remission/complete remission with incomplete hematologic response (CR/CRi; n = 121), MRD-negative status (by multiparametric flow cytometry) was defined as< 1 x 10-4 blasts/nucleated cells. MRD negativity was achieved in 76 patients at the end of treatment. Compared with MRD-positive, MRD-negative status with CR/CRi was associated with significantly improved overall survival and progression-free survival, respectively: hazard ratio (97.5% confidence interval; one-sided P-value) 0.512 (97.5% CI [0.313-0.835]; P = 0.0009) and 0.423 (97.5% CI [0.256-0.699]; P< 0.0001). Median overall survival was 14.1 versus 7.2 months, in the MRD-negative versus MRD-positive groups. Patients in first salvage who achieved MRD negativity at the end of treatment experienced significantly improved survival versus that seen in MRD-positive patients, particularly for those patients who proceeded to stem cell transplant. Among patients with relapsed/refractory acute lymphocytic leukemia who received inotuzumab, those with MRD-negative CR/CRi had the best survival outcomes.
机译：最小的残留疾病（MRD）消极性是急性淋巴细胞白血病患者的关键预后指标。在INO-VATE试验中（CLINCOLTIALS.GOV标识符：NCT01564784），接受inotuzumab与标准化疗的复发/难治急性淋巴细胞白血病患者实现了更大的缓解和MRD-DIATIVIAL率，以及改善的整体生存：危险比0.75，一个面向P = 0.0105。目前的分析评估了inotuzumab治疗结束时MRD消极性的预后值。包括接受inotuzumab（n = 164）的患者。在具有不完全血液学反应（Cr / CRI; n = 121）的完全缓解/完全缓解的患者中，MRD阴性状态（通过多次流式细胞术）定义为<1×10 -4的喷射/核细胞。在治疗结束时76名患者在76名患者中获得MRD消极性。与MRD阳性相比，CR / CRI的MRD阴性地位分别与显着提高的整体存活和无进展生存期有关：危害比（97.5％置信区间;单面P值）0.512（97.5％CI [ 0.313-0.835]; p = 0.0009）和0.423（97.5％CI [0.256-0.699]; P <0.0001）。中位数总生存率为14.1与7.2个月，在MRD阴性与MRD阳性群体中。在治疗结束时达到MRD消极性的第一次救世的患者显着提高了MRD阳性患者的存活率，特别是对于那些进行干细胞移植的患者。在接受inotuzumab的复发/难治性急性淋巴细胞白血病的患者中，具有MRD阴性Cr / CRI的人具有最好的存活结果。

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