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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

(2011) LANCET. 377(9759). p.42-51
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Abstract
Patients with follicular lymphoma can have long survival times, but disease progression typically occurs 3-5 years after initial treatment. We assessed the potential benefit of 2 years of rituximab maintenance after first-line treatment in patients with follicular lymphoma receiving a rituximab plus chemotherapy regimen. Methods The randomised, open-label PRIMA study was undertaken 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 patients achieving a complete or partial response were then randomly assigned to receive 2 years of rituximab maintenance therapy (375 mg/m(2) every 8 weeks) or observation. Treatment was assigned equally by centralised block randomisation, stratified by induction regimen, response, region, and centre. Neither the participants nor those giving the interventions, assessing outcomes, and analysing data were masked to group assignments. The primary endpoint was progression-free survival (PFS). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00140582. Findings 505 patients were assigned to rituximab maintenance and 513 to observation (one patient died during randomisation). With a median follow-up of 36 months (IQR 30-42), PFS was 74.9% (95% CI 70.9-78.9) in the rituximab maintenance group (130 patients progressed) and 57.6% (53.2-62.0) in the observation group (218 progressed; hazard ratio [HR] 0.55, 95% CI 0.44-0.68, p<0.0001). 2 years after randomisation, 361 patients (71.5%) in the rituximab maintenance group were in complete or unconfirmed complete response versus 268 (52.2%) in the observation group (p=0.0001). Overall survival did not differ significantly between groups (HR 0-87, 95% CI 0.51-1.47). Grade 3 and 4 adverse events were recorded in 121 patients (24%) in the rituximab maintenance group and 84(17%) in the observation group (risk ratio 1.46, 95% CI 1.14-1.87; p=0.0026). Infections (grades 2-4) were the most common adverse event, occurring in 197 (39%) and 123 (24%) patients, respectively (risk ratio 1.62, 95% CI 1.35-1.96; p<0.0001). Interpretation 2 years of rituximab maintenance therapy after immunochemotherapy as first-line treatment for follicular lymphoma significantly improves PFS.
Keywords
VINCRISTINE, PREDNISONE, CELL, CYCLOPHOSPHAMIDE, THERAPY, INDOLENT, SINGLE-AGENT, FREE SURVIVAL, NON-HODGKINS-LYMPHOMA, TERM-FOLLOW-UP

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Chicago
Salles, Gilles, John Francis Seymour, Fritz Offner, Armando López-Guillermo, David Belada, Luc Xerri, Pierre Feugier, et al. 2011. “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 377 (9759): 42–51.
APA
Salles, Gilles, Seymour, J. F., Offner, F., López-Guillermo, A., Belada, D., Xerri, L., Feugier, P., et al. (2011). 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, 377(9759), 42–51.
Vancouver
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.
MLA
Salles, Gilles, John Francis Seymour, Fritz Offner, 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 377.9759 (2011): 42–51. Print.
@article{2005665,
  abstract     = {Patients with follicular lymphoma can have long survival times, but disease progression typically occurs 3-5 years after initial treatment. We assessed the potential benefit of 2 years of rituximab maintenance after first-line treatment in patients with follicular lymphoma receiving a rituximab plus chemotherapy regimen. 
Methods The randomised, open-label PRIMA study was undertaken 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 patients achieving a complete or partial response were then randomly assigned to receive 2 years of rituximab maintenance therapy (375 mg/m(2) every 8 weeks) or observation. Treatment was assigned equally by centralised block randomisation, stratified by induction regimen, response, region, and centre. Neither the participants nor those giving the interventions, assessing outcomes, and analysing data were masked to group assignments. The primary endpoint was progression-free survival (PFS). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00140582. 
Findings 505 patients were assigned to rituximab maintenance and 513 to observation (one patient died during randomisation). With a median follow-up of 36 months (IQR 30-42), PFS was 74.9\% (95\% CI 70.9-78.9) in the rituximab maintenance group (130 patients progressed) and 57.6\% (53.2-62.0) in the observation group (218 progressed; hazard ratio [HR] 0.55, 95\% CI 0.44-0.68, p{\textlangle}0.0001). 2 years after randomisation, 361 patients (71.5\%) in the rituximab maintenance group were in complete or unconfirmed complete response versus 268 (52.2\%) in the observation group (p=0.0001). Overall survival did not differ significantly between groups (HR 0-87, 95\% CI 0.51-1.47). Grade 3 and 4 adverse events were recorded in 121 patients (24\%) in the rituximab maintenance group and 84(17\%) in the observation group (risk ratio 1.46, 95\% CI 1.14-1.87; p=0.0026). Infections (grades 2-4) were the most common adverse event, occurring in 197 (39\%) and 123 (24\%) patients, respectively (risk ratio 1.62, 95\% CI 1.35-1.96; p{\textlangle}0.0001). 
Interpretation 2 years of rituximab maintenance therapy after immunochemotherapy as first-line treatment for follicular lymphoma significantly improves PFS.},
  author       = {Salles, Gilles and Seymour, John Francis and Offner, Fritz and L{\'o}pez-Guillermo, Armando and Belada, David and Xerri, Luc and Feugier, Pierre and Bouabdallah, R{\'e}da and Catalano, John Vincent and Brice, Pauline and Caballero, Dolores and Haioun, Corinne and Pedersen, Lars Moller and Delmer, Alain and Simpson, David and Leppa, Sirpa and Soubeyran, Pierre and Hagenbeek, Anton and Casasnovas, Olivier and Intragumtornchai, Tanin and Ferm{\'e}, Christophe and da Silva, Maria Gomes and Sebban, Catherine and Lister, Andrew and Estell, Jane A and Milone, Gustavo and Sonet, Anne and Mendila, Myriam and Coiffier, Bertrand and Tilly, Herv{\'e}},
  issn         = {0140-6736},
  journal      = {LANCET},
  language     = {eng},
  number       = {9759},
  pages        = {42--51},
  title        = {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},
  url          = {http://dx.doi.org/10.1016/S0140-6736(10)62175-7},
  volume       = {377},
  year         = {2011},
}

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