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 Mar 28, 2019
Younes A, et al. - In untreated non-germinal center B-cell diffuse large B-cell lymphoma (DLBCL), researchers assessed ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). For this double-blind phase 3 study, they randomly assigned patients at a 1:1 ratio to ibrutinib (560 mg per day orally) plus R-CHOP or placebo plus R-CHOP. In total, 838 patients were assigned randomly to ibrutinib plus R-CHOP (n=419) or placebo plus R-CHOP (n=419). In the intent-to-treat or activated B-cell population, the study did not meet its primary end point, but ibrutinib plus R-CHOP improved event-free survival, progression-free survival, and overall survival in patients under the age of 60 with manageable safety. Ibrutinib plus R-CHOP was related to increased toxicity in patients 60 years of age or older, resulting in compromised administration of R-CHOP and inferior results.
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