18 We report here the results of a multinational, randomized, phase 3 trial that compared blinatumomab with standard chemotherapy in the treatment of patients with relapsed or refractory ALL. 17, 18 In a pivotal, multicenter, single-group, phase 2 trial of blinatumomab, the rate of complete remission with complete or partial hematologic recovery was 43%, and the median overall survival was 6.1 months. Single-group trials have shown the efficacy and safety of blinatumomab in the treatment of heavily pretreated Philadelphia chromosome (Ph)–negative relapsed or refractory B-cell precursor ALL. Blinatumomab binds simultaneously to CD3-positive cytotoxic T cells and to CD19-positive B cells, which allows the patient’s endogenous T cells to recognize and eliminate CD19-positive ALL blasts. 13 Blinatumomab (Blincyto, Amgen) is a bispecific T-cell engager antibody construct. The B-lineage surface antigen CD-19 is expressed on the surface of more than 90% of B-cell precursor ALL blasts. 7– 10, 12 More effective treatment is needed for relapsed and refractory ALL in adults. 11 The median overall survival among patients with relapsed or refractory ALL ranges from 2 to 6 months, and 3-to-5-year survival rates are less than 10%. 5– 10 A major goal in this population is to induce remission with sufficient duration to prepare for stem-cell transplantation. Among adults with relapsed or refractory ALL, remission rates are 18 to 44% with the use of standard salvage chemotherapy, but the duration of remission is typically short. 1– 4 Still, most adults with B-cell precursor ALL will have a relapse and will die from complications of resistant disease or associated treatment. With the use of intensive chemotherapy regimens, complete remission rates are 85 to 90% and long-term survival rates are 30 to 50%. The Prognosis for Adults with Newly diagnosed acute lymphoblastic leukemia (ALL) has improved over the past three decades. Adverse events of grade 3 or higher were reported in 87% of the patients in the blinatumomab group and in 92% of the patients in the chemotherapy group. A total of 24% of the patients in each treatment group underwent allogeneic stem-cell transplantation. 12% hazard ratio for an event of relapse after achieving a complete remission with full, partial, or incomplete hematologic recovery, or death, 0.55 95% CI, 0.43 to 0.71 P<0.001), as well as a longer median duration of remission (7.3 vs. Treatment with blinatumomab resulted in a higher rate of event-free survival than that with chemotherapy (6-month estimates, 31% vs. 16%, P<0.001) and with respect to complete remission with full, partial, or incomplete hematologic recovery (44% vs.
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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. 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. Overall survival was significantly longer in the blinatumomab group than in the chemotherapy group. Of the 405 patients who were randomly assigned to receive blinatumomab (271 patients) or chemotherapy (134 patients), 376 patients received at least one dose.
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