Lenalidomide maintenance therapy prolonged progression-free survival (PFS), but not overall survival (OS), among elderly patients with diffuse large B-cell lymphoma (DLBCL), according to a study published in the Journal of Clinical Oncology.1
Though rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) has improved PFS and OS for patients with DLBCL, further improvement has not yet been achieved with the addition of other agents.
The aim of this trial was to determine whether maintenance therapy with lenalidomide, an immunomodulator, can improve outcomes among elderly patients.
The phase 3 trial randomly assigned 650 elderly patients (ages 60 to 80) with previously untreated DLBCL or aggressive B-cell lymphoma who responded to R-CHOP to receive lenalidomide maintenance (25 mg/d) or placebo. Treatment was administered for 21 days of every 28 cycles for 24 months.
At baseline, the median age was 68.5, with 43.5% of patients older than age 70. The Eastern Cooperative Oncology Group performance status was 2 in 75% of patients and 2 or greater in 22%. Most patients received 8 cycles of R-CHOP (63.4%), with the remaining receiving 6.
Median PFS was prolonged with lenalidomide maintenance, with a median PFS not reached compared with 58.9 months with placebo (hazard ratio [HR], 0.708; 95% CI, 0.537-0.933; P = .01) during a median follow-up of 39 months.
There was, however, no significant difference in OS during a median follow-up of 52 months (HR, 1.218; 95% CI, 0.861-1.721; P = .26).
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The most common grade 3 to 4 adverse events that occurred more commonly with lenalidomide were neutropenia and cutaneous reactions.
These data suggest that lenalidomide maintenance for 24 months can prolong PFS among elderly patients with DLBCL, but does not improve overall survival.
- Thieblemont C, Tilly Herve, 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. 2017 Apr 20. doi: 10.1200/JCO.2017.72.6984 [Epub ahead of print]