Lenalidomide Maintenance in Older Patients With Diffuse Large B-Cell Lymphoma


Key Points

  • In older patients with diffuse large B-cell lymphoma responding to first-line chemotherapy, lenalidomide maintenance significantly prolonged progression-free survival.
  • No difference in 2-year overall survival was observed.

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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.