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Effect of lenalidomide combined with R-CHOP (R2CHOP) on negative prognostic impact of nongerminal center (non-GCB) phenotype in newly diagnosed diffuse large B-cell lymphoma: A phase 2 study.
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Background: The non-germinal center B-cell like (non-GCB) subtype of diffuse large cell lymphoma (DLBCL) is associated with a worse outcome when treated with RCHOP chemotherapy. Lenalidomide has significant single-agent activity in relapsed DLBCL and might be particularly active in non-GCB DLBCL. We have previously reported that lenalidomide can safely be combined with RCHOP (R2CHOP). This phase 2 study evaluated the efficacy of this combination in newly diagnosed DLBCL and analyzed the outcomes based on DLBCL subtype. Methods: Eligible patients were adults with newly diagnosed, untreated, stages II-IV CD20 positive DLBCL. Patients received oral lenalidomide 25 mg days 1-10 with standard dose R-CHOP every 21 days for 6 cycles. All patients received pegfilgrastim on day 2 of each cycle and aspirin prophylaxis throughout. DLBCL molecular subtype was determined by tumor immunohistochemistry (Hans algorithm) and classified as germinal center B-cell (GCB) vs non-GCB in the R2CHOP patients and 87 control DLBCL patients from the Mayo Clinic Lymphoma Database meeting the same inclusion criteria and treated with conventional RCHOP. Results: 64 DLBCL patients were enrolled. Median age was 65 years (22-87) and 34 patients (53%) had IPI intermediate-high or high. 60 were evaluable for response. The overall response rate was 98% (59/60) with 80% (48/60) complete response (CR). 24 month EFS and OS rates (95% CI) were 59% (48%-74%) and 78% (68-90%), respectively. In RCHOP patients, 24 months PFS and OS were 28% vs 64%, p<0.001 and 46% vs 78% p<0.001 in non-GCB patients vs GCB patients respectively. In contrast, there was no difference in 24 months PFS or OS for R2CHOP treated patients based on non-GCB and GCB subtype, 60% vs. 0.59%, p= 0.83 and 83% vs. 75%, p=0.61 at 2 years respectively. Conclusions: R2CHOP shows promising efficacy in DLBCL. The addition of lenalidomide to RCHOP appears to mitigate the negative impact of non-GCB phenotype on the outcome. A randomized phase 2 study of RCHOP vs. R2CHOP utilizing gene expression profiling classification of DLBCL subtype and led by the Eastern Cooperative Oncology Group (E1412) is currently ongoing. Clinical trial information: NCT00670358.
Abstracts by Grzegorz S. Nowakowski:
- Meeting: 2016 Cancer Survivorship Symposium | Abstract No: 64
- Meeting: 2016 ASCO Annual Meeting | Abstract No: e19067
Feasibility of real-time cell-of-origin subtype identification by gene expression profile in the phase 3 trial of lenalidomide plus R-CHOP vs placebo plus R-CHOP in patients with untreated ABC-type diffuse large B-cell lymphoma (ROBUST).Meeting: 2016 ASCO Annual Meeting | Abstract No: 7538
Presentations by Grzegorz S. Nowakowski:
Meeting: 2016 ASCO Annual Meeting
Session: Integrating New Diagnostics in Lymphoid Malignancies (Clinical Science Symposium)