In the French phase III SENIOR trial reported in the Journal of Clinical Oncology, Oberic et al found that the addition of lenalidomide to subcutaneous rituximab plus attenuated-dose CHOP (mini-CHOP; cyclophosphamide, doxorubicin, vincristine, prednisone) did not improve overall survival in patients aged 80 or older with previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL).
Study Details
In the multicenter open-label trial, conducted by LYSARC (Lymphoma Academic Research Organisation), 249 patients were randomly assigned between August 2014 and September 2017 to receive six 21-day cycles of lenalidomide (R) plus rituximab (R)-miniCHOP (R2-mini-CHOP group, n = 122) or rituximab-miniCHOP (R-miniCHOP group, n = 127). Rituximab was given intravenously on day 1 of the first cycle and subcutaneously thereafter. Among 212 patients with disease classified according to immunohistochemistry, 55 (50%) of 109 in the R2-miniCHOP group and 62 (60%) of 103 in the R-miniCHOP group had non–germinal center B-cell–like (GCB) disease. The primary endpoint was overall survival on intent-to-treat analysis.
Overall Survival
Median follow-up was 25.1 months. Overall survival at 2 years was 66% in the R-miniCHOP group vs 65.7% in the R2-miniCHOP group (hazard ratio [HR] = 0.99, 95% confidence interval [CI] = 0.65–1.5, P = .98). No difference between groups was observed in the non-GCB population (P = .7375).
KEY POINTS
- The addition of lenalidomide to R-miniCHOP did not improve overall survival among all patients.
- No difference in survival between groups was observed in the non-GCB population.
At 2 years, progression-free survival was 56.2% in the R-miniCHOP group vs 54.8% in the R2-miniCHOP group (HR = 1.27, P = .89); event-free survival was 50.7% vs 53.1% (HR = 0.93, P = .70). Objective response was observed in 73% vs 82% of patients, with complete response/unconfirmed complete response in 53% vs 58%. Median duration of response was not reached vs 36 months.
In multivariate analysis including International Prognostic Index score, albuminemia, instrumental activities of daily living scale, lymphocyte count, and GCB/ABC (activated B-cell–like) status, only albuminemia was significantly associated with survival in the overall population and according to treatment group; in the total population, the hazard ratio was 2.51 (P < .0001) for levels > 35 g/L.
Adverse Events
Grade 3–4 adverse events occurred in 53% of patients in the R-miniCHOP group vs 81% of the R2-miniCHOP group, with the difference being largely attributable to a higher incidence of grade 3–4 neutropenia (18% vs 32%, P =.01).
The investigators concluded, “The addition of lenalidomide to R-miniCHOP does not improve overall survival. Rituximab delivered subcutaneously was safe in this population.”
Fabrice Jardin, MD, PhD, of the Centre Henri Becquerel, Rouen, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
