%0 Journal Article
%T Promising Initial Results of CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma
%A Luis Mendoza
%J Open Access Journal of Hematology impact factor| International Journal of Blood Disorders
%D 2017
%X Diffuse large B-cell lymphoma (DBLC) is the most common form of non-Hodgkin lymphomas. Patients with DBLC who have a relapse with chemotherapy-sensitive disease may be treated with high-dose chemotherapy followed by autologous stem-cell transplantation. However, the prognosis of patients whose diseases chemotherapy resistant, refractor to primary or salvage chemo-immunotherapy, or who have had a relapse after transplantation, is extremely poor. In October 2017, the U.S. Food and Drug Administration (FDA) approved the newest type of immunotherapy called axicabtageneciloleucel, Yescarta£¿ (Gilead Sciences)to treat adult patients with certain types of large B-cell lymphoma (non-chemotherapy refractory) who have relapsed after at least two other kinds of treatment. Yescarta£¿ is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. In a phase 1 multicentre study (ZUMA-1) (1) involving seven patients, the results have shown that Yescarta£¿ is active and safe in the treatment of refractory large B-cell lymphoma. In a new multicentre phase 2 trial, Sattva S Neelapu et al. (2) enrolled 111 patients with histologically confirmed refractory large B-cell lymphoma, including diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma, who received at least one previous line of treatment. Between November, 2015, and September, 2016, the enrolled patients received conditioning treatment (low-dose cyclophosphamide, 500 mg/m2 per day, and fludarabine, 30 mg/m2 per day) on days 5, 4, and 3 before administration of autologous CAR T cells expressing anti-CD19 at a dose of 2 ¡Á 10*6 cells per kg of bodyweight. The primary endpoint was the proportion of patients with an objective response. At the data cut-off (27 January 2017) for the primary analysis, the median follow-up was 8£¿7 months. Eighty-three (82%; 95% CI 73¨C89) of 101 patients included in the intention-to-treat analyses had an objective response, with 55 (54%) patients achieving a complete response and 28 (28%) partial responses. An updated analysis at a median follow-up of 15£¿4 months (cut-off date August 11, 2017) including 108 evaluable patients showed a median progression-free survival of 5£¿8 months (95% CI 3£¿3¨C not reached). Median overall survival was not reached (12£¿0¨Cnot reached). The most common adverse events during the treatment were pyrexia in 86 (85%) of 101 patients, neutropenia in 85 (84%) patients, and anaemia in 67 (66%) patients. Four patients died during the treatment, two due to progressive disease and two from adverse events. The median overall survival had not been
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