Lenalidomide Maintenance May Prolong Progression-free Survival in DLBCL
The phase 3 REMARC study enrolled 650 treatment-naive patients with DLBCL or other aggressive B cell lymphomas.
Patients with diffuse large B cell lymphoma (DLBCL) who receive maintenance therapy with lenalidomide for 2 years after a complete (CR) or partial response (PR) with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) may have prolonged progression-free survival (PFS), according to a study published in the Journal of Clinical Oncology.1
The phase 3 REMARC study (ClinicalTrials.gov Identifier: NCT01122472) enrolled 650 treatment-naive patients with DLBCL or other aggressive B cell lymphomas. Patients who had a CR or PR with R-CHOP were randomly assigned to receive lenalidomide 25mg/day or placebo for 24 months.
When primary analysis was performed at a median follow-up of 39 months, patients who received lenalidomide maintenance did not reach a median PFS vs 58.9 months for placebo (hazard ratio [HR], 0.708; 95% CI, 0.537-0.933; P = .01).
The 2-year PFS in the lenalidomide group improved to 80% (95% CI, 75%-84%) from 75% (95% CI, 70%-80%).
The 2-year overall survival (OS) in the lenalidomide arm was estimated at 87% (95% CI, 82%-90%) vs 89% (95% CI, 85%-92%) in the placebo arm (log-rank test P = .2640; HR, 1.218; 95% CI, 0.861-1.721).
Median overall survival (OS) was similar in both study arms at a median follow-up of 52 months (HR 1.218; 95% CI, 0.861-1.721; P = .26).
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Almost 90% of patients reported at least 1 treatment related adverse event (AE). The most frequently reported grade 3 to 4 AEs in lenalidomide vs placebo were neutropenia (56% vs 22%, respectively) and cutaneous reactions (5% v 1%, respectively).
- Thieblemont C, Tilly H, Gomes Da Silva M, et al. Lenalidomide maintenance compared with placebo in responding elderly patients with diffuse large B-cell lymphoma treated with first-line rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. J Clin Oncol. 20 April 2017. doi: 10.1200/JCO.2017.72.6984 [Epub ahead of print]