Burger JA, Keating MJ, Wierda WG et al.
The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Lancet Oncol 2014;15:1090–9.
Christopher Fox’s review: New therapies such as kinase inhibitors targeting B cell receptor signaling and novel monoclonal antibodies are rapidly changing the treatment paradigm for patients with chronic lymphocytic leukemia (CLL). Patients with high-risk CLL (HR-CLL) remain a therapeutic challenge; the optimal approach remains unclear. Given the lymphocytosis of redistributed CLL cells after treatment with single-agent ibrutinib and the efficacy of rituximab in clearing CLL cells from the blood, this study explored the efficacy and safety of the iR (ibrutinib and rituximab) combination in patients with HR-CLL.
A total of 40 patients were recruited between February and September 2012 at the MD Anderson Cancer Center (Houston, TX, USA). The median age of the patients was 63years and the median number of prior therapies was two. Twenty patients had del17p or tumor protein p53 gene (TP53) mutations (four were treatment-naïve) and 13 patients had del11q. Most of the patients had unmutated immunoglobulin G (IgG) heavy chain variable region (IGHV) genes. The rituximab dosing schedule was 375mg/m2 weekly for 4 weeks followed by a further 5 cycles of one infusion every 4 weeks. Oral ibrutinib dosing was the standard, 420-mg, once-daily, continuous schedule.