Real-World Study Determines Effectiveness of Targeted Therapy for Relapsed, Refractory B-Cell Malignancy


A recent study demonstrated the real-world effectiveness and tolerability of a targeted agent for the treatment of relapsed or refractory mantle cell lymphoma (MCL).

The study was published in The Oncologist (online April 19, 2018; doi:10.1634/theoncologist.2017-0597).

MCL is associated with one of the worst prognoses of any B-cell subtypes, due to its aggressive clinical disease course and incurability with standard chemo-immunotherapy. Among the approved novel agents for relapse or refractory MCL are temsirolimus, lenalidomide, ibrutinib, and bortezomib. However, the therapeutic algorithm for relapsed or refractory disease is limited because data in real-world clinical practice remain poor.

A group of Italian researchers led by Pier Luigi Zinzani, MD, PhD, Institute of Hematology, University of Bologna, conducted an observational retrospective study in 24 Italian hematology centers to improve the understanding of the safety and efficacy of lenalidomide use in real-world practice. A total of 70 patients were sampled with relapsed or refractory MCL. Researchers noted the median patient age was 67 years, stage IV disease was observed in 72.9% of the patients, 22.8% of patients were refractory to first-line therapy, and approximately 50% of patients underwent prior autologous stem cell transplant.

Patients received lenalidomide for a median of eight cycles, with 22.9% (n = 18) receiving lenalidomide in combination with either dexamethasone or rituximab. The overall response rate for all patients was 47.1%. Researchers noted 22 complete responses and 11 partial responses, along with six cases of stable disease. The median overall survival (OS) was 33 months and the median disease-free survival (DFS) was 20 months.

After comparing patients who received lenalidomide alone with those who received lenalidomide in combination, researchers reported that OS and DFS did not differ significantly. However, they did acknowledge that progression-free survival was different at 56 months (13% vs 36%, respectively).


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Additionally, Dr Zinzani and colleagues noted that while there were 17 cases of toxicities leading to early therapy discontinuation, all of the adverse events observed in the patient population were manageable.

In their concluding remarks, Dr Zinzani and colleagues wrote that, ““lenalidomide is effective and tolerable in everyday clinical practice, with superimposable results to those obtained in clinical trials, and it must be considered in the therapeutic algorithm of relapsed or refractory MCL as a targeted approach.”—Zachary Bessette