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PRIMA

Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial

Phase 3N = 1,217NCT00140582

Population
Previously untreated follicular lymphoma needing systemic therapy, randomised after a complete or partial response to induction; 505 assigned to rituximab maintenance and 513 to observation (one patient died during randomisation).
Design
Randomised, open-label phase 3 study in 223 centres in 25 countries. 1217 patients with previously untreated follicular lymphoma needing systemic therapy received one of three non-randomised immunochemotherapy induction regimens used in routine practice; 1019 who reached a complete or partial response were randomly assigned to 2 years of rituximab maintenance (375 mg/m2 every 8 weeks) or observation. Primary endpoint: progression-free survival; analysis by intention to treat.
Primary endpoint
PFS
Arms
  • Observation (control, n = 513): Observation after induction
  • Rituximab maintenance (experimental, n = 505): Rituximab 375 mg/m2 every 8 weeks for 2 years
People
Salles G, Groupe d'Etude des Lymphomes de l'Adulte (GELA)
PFSHR 0.55 (95% CI 0.44–0.68)Δ PFS+17.3 pointsΔ CR rate+19.3 pointsOSHR 0.87 (95% CI 0.51–1.47)
Show the numbers
Results reported for PRIMA
EndpointAnalysisRituximab maintenanceObservationEffect
PFSprimarymedian follow-up 36 monthsSalles 201174.9% (70.9–78.9%)57.6% (53.2–62.0%)HR 0.55 (95% CI 0.44–0.68)P<0.0001PFS estimates at the median follow-up of 36 months (interquartile range 30 to 42); 130 patients progressed with maintenance and 218 with observation.
CR rateComplete or unconfirmed complete response 2 years after randomisation.primarySalles 201171.5%52.2%P=0.0001361 patients with maintenance versus 268 with observation were in complete or unconfirmed complete response 2 years after randomisation.
OSprimarymedian follow-up 36 monthsSalles 2011——HR 0.87 (95% CI 0.51–1.47)Overall survival did not differ significantly between groups; the abstract gives no P value.
Results reported for PRIMA
EndpointAnalysisRituximab maintenanceObservationEffect
PFSprimarymedian follow-up 36 monthsSalles 201174.9% (70.9–78.9%)57.6% (53.2–62.0%)HR 0.55 (95% CI 0.44–0.68)P<0.0001PFS estimates at the median follow-up of 36 months (interquartile range 30 to 42); 130 patients progressed with maintenance and 218 with observation.
CR rateComplete or unconfirmed complete response 2 years after randomisation.primarySalles 201171.5%52.2%P=0.0001361 patients with maintenance versus 268 with observation were in complete or unconfirmed complete response 2 years after randomisation.
OSprimarymedian follow-up 36 monthsSalles 2011——HR 0.87 (95% CI 0.51–1.47)Overall survival did not differ significantly between groups; the abstract gives no P value.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.550.44–0.68
OS0.870.51–1.47
Primary publication: Salles G, Seymour JF, Offner F, López-Guillermo A, Belada D, Xerri L, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011;377(9759):42-51. PubMedDOI

Appears in

Sources

  1. Salles G, Seymour JF, Offner F, López-Guillermo A, Belada D, Xerri L, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011;377(9759):42-51.

    PubMedDOI