• Elias Jabbour, Nicola Gökbuget, Anjali Advani, Matthias Stelljes, Wendy Stock, Michaela Liedtke, Giovanni Martinelli, Susan O'Brien, Tao Wang, A Douglas Laird, Erik Vandendries, Alexander Neuhof, Kevin Nguyen, Naveen Dakappagari, Daniel J DeAngelo, and Hagop Kantarjian.
• University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ejabbour@mdanderson.org.
• Leuk. Res. 2020 Jan 1; 88: 106283.

AbstractMinimal 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 × 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.Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.

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