1. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia
- Author
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Miguel A. Sanz, Fatih Demirkan, Max S. Topp, Ewa Lech-Maranda, Renato Bassan, Nicola Gökbuget, Josep-Maria Ribera, Dirk Nagorsen, Brent L. Wood, Andre C. Schuh, Hagop M. Kantarjian, Anthony S. Stein, Onder Arslan, Adele K. Fielding, Xavier Thomas, Wolfram Klapper, Chris Holland, Andrew H. Wei, Alex Fleishman, Alessandro Rambaldi, Julie Bergeron, Zachary Zimmerman, Monika Brüggemann, Robin Foà, Heinz-August Horst, and Hervé Dombret
- Subjects
Male ,0301 basic medicine ,Oncology ,MONOCLONAL-ANTIBODY ,medicine.medical_treatment ,Salvage therapy ,0302 clinical medicine ,Antibodies, Bispecific ,PROGNOSTIC-SIGNIFICANCE ,Antineoplastic Combined Chemotherapy Protocols ,ADULT PATIENTS ,Molecular Targeted Therapy ,SALVAGE THERAPY ,Aged, 80 and over ,Hazard ratio ,General Medicine ,Middle Aged ,Combined Modality Therapy ,030220 oncology & carcinogenesis ,Female ,Blinatumomab ,CHAIN ANTIBODY CONSTRUCT ,medicine.drug ,Adult ,medicine.medical_specialty ,Adolescent ,Hyper-CVAD ,Antineoplastic Agents ,Article ,Young Adult ,03 medical and health sciences ,ACUTE LYMPHOCYTIC-LEUKEMIA ,Precursor B-Cell Lymphoblastic Leukemia-Lymphoma ,Sepsis ,Acute lymphocytic leukemia ,Internal medicine ,medicine ,Transplantation, Homologous ,Humans ,Survival analysis ,Aged ,HYPER-CVAD ,Chemotherapy ,business.industry ,STEM-CELL TRANSPLANTATION ,medicine.disease ,Survival Analysis ,Transplantation ,030104 developmental biology ,Immunology ,T-CELLS ,INOTUZUMAB OZOGAMICIN ,business ,Stem Cell Transplantation - Abstract
BACKGROUND Blinatumomab, a bispecific monoclonal antibody construct that enables CD3-positive T cells to recognize and eliminate CD19-positive acute lymphoblastic leukemia (ALL) blasts, was approved for use in patients with relapsed or refractory B-cell precursor ALL on the basis of single-group trials that showed efficacy and manageable toxic effects. METHODS In this multi-institutional phase 3 trial, we randomly assigned adults with heavily pre-treated B-cell precursor ALL, in a 2: 1 ratio, to receive either blinatumomab or standardof- care chemotherapy. The primary end point was overall survival. RESULTS Of the 405 patients who were randomly assigned to receive blinatumomab (271 patients) or chemotherapy (134 patients), 376 patients received at least one dose. Overall survival was significantly longer in the blinatumomab group than in the chemotherapy group. The median overall survival was 7.7 months in the blinatumomab group and 4.0 months in the chemotherapy group (hazard ratio for death with blinatumomab vs. chemotherapy, 0.71; 95% confidence interval [CI], 0.55 to 0.93; P = 0.01). Remission rates within 12 weeks after treatment initiation were significantly higher in the blinatumomab group than in the chemotherapy group, both with respect to complete remission with full hematologic recovery (34% vs. 16%, P
- Published
- 2017
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