- In long-term follow-up of the PRIMA trial, patients with previously untreated follicular lymphoma (FL) and high tumor burden who received rituximab maintenance after induction immunochemotherapy continued to maintain significantly superior PFS vs observation after 9.0 (range, 0.0-11.5) years of follow-up.
Why this matters
- PRIMA established the value of 2 years of rituximab maintenance after first-line immunochemotherapy.
- Results of the PRIMA trial after 9 years of follow-up.
- PRIMA investigated 2 years of rituximab maintenance in patients with previously untreated FL and high tumor burden who responded to first-line rituximab-containing immunochemotherapy.
- 1018 patients completed induction; 505 were then randomly assigned to rituximab maintenance and 513 to observation.
- Extended follow-up consent: rituximab group (n=309), observation group (n=298).
- Funding: Lymphoma Study Association; F Hoffmann-La Roche; Biogen Idec.
- 10.5 years of median PFS with rituximab maintenance vs 4.1 years with observation (HR, 0.61; 95% CI, 0.52-0.73; P<.001>
- 51.1% estimated 10-year PFS with rituximab maintenance vs 35.0% with observation.
- 24.4% experienced grade 3-4 adverse events with rituximab vs 16.9% with observation.
- Despite significant improvement in PFS with rituximab maintenance, no significant difference in OS was seen in long-term follow-up between the 2 groups.