R-CHOP ± Bortezomib in Patients with Untreated Non-GCB DLBCL: Results from the Phase 2 PYRAMID Trial
Nongerminal center B-cell–like (non-GCB) subtype of diffuse large B-cell lymphoma (DLBCL) is associated with an unfavorable prognosis, with some evidence to suggest that it may be overcome by addition of bortezomib to standard R-CHOP (VR-CHOP).1 Leonard and colleagues reported preliminary results of a randomized phase 2 study that evaluated the efficacy and safety of frontline R-CHOP versus VR-CHOP in patients with non-GCB DLBCL.2 All enrolled patients were randomized to receive 6 cycles of standard R-CHOP-21, with addition of bortezomib 1.3 mg/m2 intravenously in the VR-CHOP cohort. The primary end point was progression-free survival (PFS); secondary end points included overall survival (OS), overall response rate (ORR), and complete response (CR) rate after cycles 2 and 6, and safety.
At a median follow-up of 34 months, 2-year PFS in the overall population (n = 183) was similar between the 2 treatment arms (78% vs 82%; hazard ratio [HR], 0.73; P = .611). This trend continued in terms of 2-year OS (88% vs 93%), ORR (98% vs 96%), and CR rate (49% vs 56%) for RCHOP versus VR-CHOP therapy. In the safety population of 201 patients, grade 3/4 adverse events (AEs) in the R-CHOP and VR-CHOP arms occurred in 71% and 79% of patients, respectively, and serious AEs in 31% and 34%, respectively. The incidence of treatment-related grade 3/4 AEs was 55% and 68%, of which, the most common were neutropenia (34% vs 28%) and thrombocytopenia (8% vs 20%). Grade 3/4 peripheral neuropathy was 5% in the VR-CHOP arm (vs 1% in the control arm). Based on these results, the authors concluded that there was no significant efficacy advantage with the addition of bortezomib to the standard R-CHOP regimen in patients with previously untreated non-GCB DLBCL.
- Ruan J, et al. J Clin Oncol. 2011;29(6):690-697.
- Leonard J, et al. ASH 2015. Abstract 811.