Mantle cell lymphoma (MCL) basically is a pernicious, incurable disease. Initial treatment for this disease are not yet standardized; although, the novel therapies for relapsed or refractory MCL may ideally be translated into the beneficial treatments for those patients who are newly diagnosed, as clearly came out by the phase II study of lenalidomide plus rituximab by Ruan and colleagues recently reported in The New England Journal of Medicine.
On behalf of findings from a multi-institutional study of lenalidomide plus rituximab for the relapsed or refractory MCL into the front-line setting the achieved objective RR (Response Rate) noted as 92%, which is an absolutely major step forward in the fight against MCL.
The trial by Ruan and colleagues rapidly applied these findings in those patients who are with relapsed/refractory MCL to newly diagnosed patients with MCL. They carried out a multicenter phase II trial, enrolled a total of 38 patients with induction or maintenance phases, precisely after the same dosing as well as scheduling previously published for relapsed/refractory MCL with the minor modifications.
At the median follow-up of 30 months, the ORR was noted as 92%, with a complete RR of 64%, and no undesired adverse events. Strikingly, the 2-year PFS among the patients with MCL, were given this combination was noted as 85%, which is in marked contrast to the median PFS of 16-35 months witnessed in patients with MCL who were given initial therapy consisting of chemotherapy.
Additionally and favorably, the patients who progressed on this combinational treatment responded favorably to the subsequent therapeutic regimens. However, in this trial, grade 3 toxicities were reported as pneumonia (8%), thrombocytopenia (13%), rash (29%), and neutropenia (50%).
These reported adverse reactions suggest that the lenalidomide still is responsible for causing the severe adverse reactions in the front-line setting.
Reference:
Recap of Lymphoma Studies:
Lenalidomide was foremost approved by the U.S. FDA for the relapsed myeloma therapy together with the dexamethasone.
Although, on behalf of preclinical findings, lenalidomide was proposed to be a potentially effective agent in order to treat lymphoma. With the carried out preclinical tasks done by Hernandez-Ilizaliturri and following getting the approval of this agent by the Food and Drug Administration, Celgene started the lymphoma efforts.
As a single lenalidomide was foremost studied in non-Hodgkin lymphoma by Wiernik and colleagues in 2008. In 49 enrolled patients, the objective RR was noted as 35%; although, in the 15 enrolled patients with MCL, the objective RR was noted as 53%.
On behalf of these promising outcomes, Dr. Liang Zhang and a colleague conducted preclinical experiments in order to test the activity of lenalidomide plus rituximab in MCL cell lines, primary MCL cells, and MCL, bearing patient-derived xenograft mice.
The combination was demonstrated to be effective preclinically, which led them to propose their phase I/II clinical trial testing the combination in those patients who are with relapsed/refractory MCL.