Lenalidomide Maintenance in Older Patients With Diffuse Large B-Cell Lymphoma
In the international phase III REMARC trial reported by Thieblemont et al in the Journal of Clinical Oncology, lenalidomide (Revlimid) maintenance was found to prolong progression-free survival vs placebo in older patients with diffuse large B-cell lymphoma responding to first-line R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone). No overall survival benefit was observed with longer follow-up.
Study Details
In the trial, 650 patients aged 60 to 80 years with previously untreated diffuse large B-cell lymphoma or other aggressive B-cell lymphomas who had a complete or partial response to 6 or 8 cycles of R-CHOP were randomized between May 2009 and May 2014 to receive lenalidomide maintenance at 25 mg/d or placebo for 21 days of 28-day cycles for 24 months. The primary endpoint was progression-free survival. Complete response was achieved in 78% of the lenalidomide group and 75% of the placebo group. Positron-emission tomography (PET) scans were positive in 41 lenalidomide patients and 43 placebo patients.
Progression-Free and Overall Survival
At primary analysis in December 2015, with a median follow-up of 39 months, median progression-free survival was not reached in the lenalidomide group vs 58.9 months in the placebo group (hazard ratio [HR] = 0.708, P = .01). The progression-free survival benefit of lenalidomide was consistent among subgroups according to sex, age-adjusted International Prognostic Index, complete or partial response, and PET scan status. At median follow-up of 52 months (as of October 2016), median overall survival had not been reached in either group. Two-year overall survival was 87% vs 89% (HR = 1.218, P = .26).
Adverse Events
The most common grade 3 or 4 adverse events in the lenalidomide group were neutropenia (56% vs 22% in placebo group), infection (8% vs 6%), cardiac disorders (6% vs 3%) and cutaneous reactions (5% vs 1%). Second primary malignancies occurred in 10% vs 13% of patients. Serious adverse events occurred in 31% vs 28%. Adverse events led to dose reduction in 66% vs 32%.
The investigators concluded: “Lenalidomide maintenance for 24 months after obtaining a [complete response] or [partial response] to R-CHOP significantly prolonged [progression-free survival] in elderly patients with [diffuse large B-cell lymphoma].”
The study was funded by Celgene Corporation.
Catherine Thieblemont, MD, PhD, of Hôpital Saint-Louis, Paris, is the corresponding author of the Journal of Clinical Oncology article.
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