Lenalidomide maintenance therapy for 24 months after a complete or partial response to standard chemotherapy significantly prolongs progression-free survival (PFS) in older patients with diffuse large B-cell lymphoma, according to a study published in the Journal of Clinical Oncology (published online April 20, 2017; doi:10.1200/JCO.2017.72.6984).
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The standard treatment regimen for patients with diffuse large B-cell lymphoma involves rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone. The immunomodulatory agent lenalidomide has shown activity in such disease in recent trials. There has yet to be a trial that adds a novel drug, such as lenalidomide, to this standard line of therapy, either in combination during induction or in a maintenance setting, that produces improved survival outcomes.
Catherine Thieblemont, MD, PhD, Hôpital Saint-Louis (Paris, France), and colleagues conducted a randomized, phase III trial that compared lenalidomide as a maintenance therapy with placebo in older patients with diffuse large B-cell lymphoma who achieved a complete or partial response to rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone induction therapy. A total of 650 patients aged 60 to 80 years were enrolled in the trial, all of whom were assigned to lenalidomide maintenance (25 mg/day) or placebo for 21 days of every 28-day cycle for 24 months. The primary endpoint was PFS.
After a median follow-up of 39 months, median PFS was not reached in the lenalidomide group compared with 58.9 months in the placebo group (HR, 0.708; 95% CI, 0.537-0.933; P = .01). These results were consistent in analyzed subgroups (male vs female, age-adjusted International Prognostic Index 0 or 1 vs 2 or 3, age less than 70 years vs 70 or older). Median overall survival was not reached in either group.
Researchers acknowledged that only patients with a germinal center B-cell-like profile had a significant difference in median PFS (60.9 months for lenalidomide vs 52.7 months for placebo; P = .04).
The most common grade 3 or 4 adverse events associated with lenalidomide vs placebo were neutropenia (56% vs 22%, respectively) and cutaneous reactions (5% vs 1%, respectively).
“To our knowledge, [this] study is the first phase III trial evaluating a maintenance strategy in diffuse large B-cell lymphoma to show a benefit in PFS,” the authors wrote. – Zachary Bessette
