Bortezomib–Rituximab Combo Improves PFS in Relapsed Follicular Lymphoma
A phase 3 study comparing the efficacy and safety of rituximab alone and in combination with bortezomib in patients with relapsed grade 1 or 2 follicular lymphoma who were rituximab- naive or rituximab-sensitive showed extended PFS with the drug combination comparedwith rituximab alone (Coiffier B, et al. Lancet Oncol. 2011;12:773-784).
This open-label trial included 676 patients from 164 centers across Europe, the Americas, and Asia. Patients were randomized to five 35- day cycles of rituximab either alone (N = 340) or in combination with bortezomib (N = 336). The primary end point was PFS. Secondary end points were time to progression, time to next treatment, and OS.
After a median follow-up of 34 months, the median PFS was 11.0 months with rituximab alone and 12.8 months with bortezomib plus rituximab. The estimated 2-year PFS rates were 23.5% and 31.2%, respectively. In a subgroup analysis, bortezomib plus rituximab combination therapy was associated with a significantly longer PFS than rituximab alone in patients with high risk factors and in younger patients (?65 years), but not in older patients. In patients who received previous lines of therapy, the differences between the 2 treatment armswere not significant. In patients who had received any previous rituximab therapy, the median PFS was 9.2 months with rituximab alone versus 11.4 months with the bortezomib–rituximab combination.
The most common grade 3 or higher adverse events reported were neutropenia, infection, diarrhea, herpes zoster, nausea or vomiting, and thrombocytopenia. Drug-related adverse events leading to death occurred in 3 (1%) patients who received bortezomib plus rituximab and in none of those who received rituximab alone.