15-ICML: Adding Lenalidomide to R-CHOP in Newly Diagnosed DLBCL
In the phase II ECOG-ACRIN 1412 trial, presented by Nowakowski et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 006), researchers sought to compare the addition of lenalidomide to R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) vs R-CHOP alone in previously untreated diffuse large B-cell lymphoma (DLBCL).
Methods
A total of 280 evaluable patients were enrolled between August 2013 and January 2017; 94 patients had activated B-cell (ABC) DLBCL, 122 had germinal center B-cell (GCB) DLBCL, and 18 were unclassifiable. All patients were aged 18 years or older; the median age was 66; 61% were male; 88% were white; 70% had stage IV disease; and 34%, 43%, and 24% had International Prognostic Index scores of 2, 3, and 4/5, respectively.
Patients were stratified by age and International Prognostic Index and randomly assigned 1:1 to lenalidomide at 25 mg/d for days 1through 10 of a 21-day cycle plus R-CHOP vs R-CHOP alone for six cycles. The primary endpoint was progression-free survival.
Results
Based on cell of origin, the progression-free survival hazard ratio [HR] for patients treated with the lenalidomide/R-CHOP regimen was 0.68 for the ABC subgroup, 0.86 for the GCB subgroup, 0.83 for unclassified disease, and 0.61 for unknown cases.
The overall response rate was 92% in the R-CHOP arm vs 97% in the lenalidomide/R-CHOP arm (P = 0.12); the complete response rate was 67% vs 72% (P = 0.44). With a median follow-up of 2.4 years, lenalidomide/R-CHOP was associated with a 33% reduction in the risk of disease progression or death vs R-CHOP alone (HR = 0.67, 95% confidence interval [CI] = 0.44–1.03; one-sided P = .03). The 2-year overall survival was 87% with lenalidomide/R-CHOP compared to 80% for R-CHOP alone.
Safety
Grade ≥ 3 adverse events included diarrhea (reported in 6% of patients in the lenalidomide/R-CHOP arm vs 0.6% of patients in the R-CHOP alone arm), febrile neutropenia (25% vs 12%), and thrombocytopenia (36% vs 12%).
The researchers concluded, “The addition of lenalidomide to R-CHOP in this phase II study improved progression-free survival in newly diagnosed DLBCL.”
Disclosure: For full disclosures of the study authors, visit lymphcon.ch.
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