Randomized phase III trial of ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in non–germinal center B-cell diffuse large B-cell lymphoma
Journal of Clinical Oncology May 22, 2019
Younes A, et al. - Among patients (median age was 62.0 years) with untreated non–germinal center B-cell diffuse large B-cell lymphoma (DLBCL)(n=838), researchers assessed ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). In a random manner, using one-to-one ratio, they administered ibrutinib (560 mg per day orally) plus R-CHOP or placebo plus R-CHOP to 419 patients in each arm. Event-free survival (EFS) in the intent-to-treat (ITT) population and the activated B-cell (ABC) DLBCL subgroup was considered as primary endpoint. In the ITT or ABC population, the primary end point was not met. However, improved EFS, progression-free survival, and overall survival were achieved with ibrutinib plus R-CHOP in patients age younger than 60 years, with manageable safety. Treatment with ibrutinib plus R-CHOP in patients age 60 years or older was related to increased toxicity, resulting in compromised R-CHOP administration and worse consequences.
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