In a 5-year analysis of the UK/Swiss phase III REMoDL-B trial reported in the Journal of Clinical Oncology, Davies et al found that the addition of bortezomib to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone; RB-CHOP) as initial treatment was associated with improved outcomes among patients with molecular high-grade and activated B-cell diffuse large B-cell lymphoma (DLBCL).
In the trial, 1,129 patients with DLBCL were randomly assigned to receive RB-CHOP or R-CHOP. Primary analysis at a median follow-up of 30 months found no effect on progression-free survival or overall survival with the addition of bortezomib. A total of 1,077 patients underwent gene-expression profiling; the current analysis involves 801 patients identified by profiling with activated B-cell (n = 249; 124 in RB-CHOP group vs 125 in R-CHOP group), germinal center B-cell (n = 469; 229 vs 240), or molecular high-grade lymphoma (n = 83; 41 vs 42).
At a median follow up of 64 months among the 801 patients, no significant benefit of RB-CHOP vs R-CHOP was observed for progression-free survival or overall survival. Hazard ratios (HRs) were 0.81 (P = .085) for 5-year progression-free survival and 0.86 (P = .32) for 5-year overall survival.
Among patients with activated B-cell lymphomas, 5-year progression-free survival was 69.4% in the RB-CHOP group vs 54.4% in the R-CHOP group (HR = 0.65, 95% confidence interval [CI] = 0.43–0.98, P = .041). Overall survival at 5 years was 80.4% vs 67.4% (HR = 0.58, 95% CI = 0.35–0.95, P =.032).
Among patients with molecular high-grade lymphomas, 5-year progression-free survival was 54.9% vs 29.3% (HR = 0.46, 95% CI = 0.26–0.84, P = .011) and 5-year overall survival was 60.0% vs 47.5% (HR = 0.62, 95% CI = 0.32–1.20, P = .16).
Among patients with germinal center B-cell lymphomas, 5-year progression-free survival was 73.3% vs 74.5% (HR = 1.05, 95% CI = 0.74–1.50, P = .77) and 5-year overall survival was 82.4% vs 85.0% (HR = 1.27, 95% CI = 0.81–1.98, P = .3).
The investigators concluded, “Patients with activated B-cell and molecular high-grade DLBCL may benefit from the addition of bortezomib to R-CHOP in initial therapy.”
Peter W.M. Johnson, MD, of the Centre for Cancer Immunology, Southampton General Hospital, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Janssen-Cilag, the National Institute for Healthcare Research, and Cancer Research UK. For full disclosures of the study authors, visit ascopubs.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.