Goekbuget, Nicola and Dombret, Herve and Bonifacio, Massimiliano and Reichle, Albrecht and Graux, Carlos and Faul, Christoph and Diedrich, Helmut and Topp, Max S. and Brueggemann, Monika and Horst, Heinz-August and Havelange, Violaine and Stieglmaier, Julia and Wessels, Hendrik and Haddad, Vincent and Benjamin, Jonathan E. and Zugmaier, Gerhard and Nagorsen, Dirk and Bargou, Ralf C. (2018) Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. BLOOD, 131 (14). pp. 1522-1531. ISSN 0006-4971, 1528-0020
Full text not available from this repository. (Request a copy)Abstract
Approximately 30% to 50% of adults with acute lymphoblastic leukemia (ALL) in hematologic complete remission aftermultiagent therapy exhibit minimal residual disease (MRD) by reverse transcriptase-polymerase chain reaction or flow cytometry. MRD is the strongest predictor of relapse in ALL. In this open-label, single-arm study, adults with B-cell precursor ALL in hematologic complete remission with MRD (>= 10(-3)) received blinatumomab 15 mu g/m(2) per day by continuous IV infusion for up to 4 cycles. Patients could undergo allogeneic hematopoietic stem-cell transplantation any time after cycle 1. The primary end point was complete MRD response status after 1 cycle of blinatumomab. One hundred sixteen patients received blinatumomab. Eighty-eight (78%) of 113 evaluable patients achieved a complete MRD response. In the subgroup of 110 patients with Ph-negative ALL in hematologic remission, the Kaplan-Meier estimate of relapse-free survival (RFS) at 18 months was 54%. Median overall survival (OS) was 36.5 months. In landmark analyses, complete MRD responders had longer RFS (23.6 vs 5.7 months; P = .002) and OS (38.9 vs 12.5 months; P = .002) compared with MRD nonresponders. Adverse events were consistent with previous studies of blinatumomab. Twelve (10%) and 3 patients (3%) had grade 3 or 4 neurologic events, respectively. Four patients (3%) had cytokine release syndrome grade 1, n = 2; grade 3, n = 2), all during cycle 1. After treatment with blinatumomab in a population of patients with MRD-positive B-cell precursor ALL, a majority achieved a complete MRD response, which was associated with significantly longer RFS and OS compared with MRD nonresponders.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | STANDARD-RISK; ALLOGENEIC TRANSPLANTATION; CLINICAL-SIGNIFICANCE; COMPLETE REMISSION; REDUCED-INTENSITY; ENGAGING ANTIBODY; FREE SURVIVAL; MRD; CHEMOTHERAPY; RELAPSE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 10 Mar 2020 13:34 |
| Last Modified: | 10 Mar 2020 13:34 |
| URI: | https://pred.uni-regensburg.de/id/eprint/14746 |
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