Subcutaneous Rituximab-MiniCHOP compared with subcutaneous Rituximab-MiniCHOP plus Lenalidomide in diffuse large B-Cell lymphoma for patients age 80 years or older.

PURPOSE The prognosis of elderly patients with diffuse large B-cell lymphoma (DLBCL) is worse than that of
young patients. An attenuated dose of chemotherapy—cyclophosphamide, doxorubicin, vincristine, and
prednisone plus rituximab (R-miniCHOP)—is a good compromise between efficacy and safety in very elderly
patients. In combination with R-CHOP (R2-CHOP), lenalidomide has an acceptable level of toxicity and may
mitigate the negative prognosis of the non–germinal center B-cell–like phenotype. The Lymphoma Study
association conducted a multicentric, phase III, open-label, randomized trial to compare R-miniCHOP and R2-
miniCHOP.
PATIENTS AND METHODS Patients of age 80 years or older with untreated DLBCL were randomly assigned into
the R-miniCHOP21 group or the R2-miniCHOP21 group for six cycles and stratified according to CD10 expression
and age. The first cycle of rituximab was delivered by IV on D1 after a prephase and then delivered
subcutaneously on D1 of cycles 2-6. Lenalidomide was delivered at a dose of 10 mg once daily on D1-D14 of
each cycle. The primary end point was overall survival (OS).
RESULTS A total of 249 patients with new DLBCL were randomly assigned (127 R-miniCHOP and 122 R2-
miniCHOP). The median age was 83 years (range, 80-96), and 55% of the patients were classified as non-GCB.
The delivered dose for each R-miniCHOP compound was similar in both arms. Over a median follow-up of
25.1 months, the intention-to-treat analysis revealed that R2-miniCHOP did not improve OS (2-year OS 66% in
R-miniCHOP and 65.7% in R2-miniCHOP arm, P5 .98) in the overall population or in the non-GCB population.
Grade 3-4 adverse events occurred in 53% of patients with R-miniCHOP and in 81% of patients with R2-
miniCHOP.
CONCLUSION The addition of lenalidomide to R-miniCHOP does not improve OS. Rituximab delivered subcutaneously
was safe in this population.