In a nutshell
This study examined the use of ibrutinib (Imbruvica) combined with the chemotherapy combination R-CHOP in untreated diffuse large B-cell lymphoma. This study determined that ibrutinib was safe and effective when added to R-CHOP.
Some background
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) is a standard treatment option for DLBCL. It has been shown to be effective in both subtypes of DLBCL: activated B-cell-like and germinal center B-cell-like. Many patients, however, require further treatment. Improving response to first-line treatment is important.
Ibrutinib is a treatment that targets a certain protein involved in cancer growth. It has been found to be effective in other forms of lymphoma and in relapsed DLBCL. It is not clear whether it is safe and effective as a first-line treatment for DLBCL.
Methods & findings
The current study examined the safety and effectiveness of ibrutinib as a first treatment for DLBCL. 32 patients with large B-cell lymphoma were included in two parts of the study. 24 of these patients had DLBCL. Other patients had mantle cell lymphoma or follicular lymphoma. 17 patients were included in part 1, which determined the dose of ibrutinib (560 mg per day) used in part 2. All patients in both parts were treated with ibrutinib and R-CHOP. Patients were followed for an average of 7.1 months.
Overall, 94% of patients responded to treatment. 72% had a complete response (no sign of disease). Of the 23 DLBCL patients, 95% responded. 15 patients had a complete response, and 3 had a partial response (decrease in cancer activity).
All patients experienced one or more adverse effects. 82% experienced a serious or severe side effect. The most common effects were low white blood cells (73%), low platelets (cells involved in blood clotting, 21%), low white blood cells with fever (18%), and low red blood cells (18%).
The bottom line
This study concluded that ibrutinib was safe and effective in DLBCL.
The fine print
This study was funded by Janssen, the manufacturer of ibrutinib.
Published By :
The Lancet. Oncology
Date :
Aug 01, 2014
