{"entity":{"id":"paper-prima-rituximab-maintenance-follicular-lancet-2011","kind":"paper","name":"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","aka":["PRIMA 2011","Salles 2011"],"tldr":"Two years of an antibody given every two months after first-line chemotherapy raised the proportion still free of progression at three years from 58 to 75 per cent.","summary":"An open-label randomised trial at 223 centres in 25 countries. 1,217 patients with previously untreated follicular lymphoma needing systemic therapy received one of three non-randomised immunochemotherapy induction regimens used in routine practice, and the 1,019 who achieved a complete or partial response were randomised to rituximab 375 mg per square metre every eight weeks for two years or to observation.\n\n505 patients were assigned to maintenance and 513 to observation (one died during randomisation). With a median follow-up of 36 months, progression-free survival was 74.9 per cent (95 per cent confidence interval 70.9 to 78.9) with maintenance, with 130 progressions, against 57.6 per cent (53.2 to 62.0) with observation, with 218 progressions: hazard ratio 0.55 (0.44 to 0.68).","asOf":"2026-10-01","links":[{"label":"Lancet 2011","url":"https://doi.org/10.1016/S0140-6736(10)62175-7"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/21176949/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/21176949"}],"tags":["lymphoma-evidence"],"related":["paper-prima-final-rituximab-maintenance-follicular-jco-2019","lymphoma-roadmap"],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":["immunotherapy"],"technologies":[],"targets":["cd20"],"drugs":["rituximab"],"companies":["lysa"],"institutions":[],"pathways":[],"terms":["maintenance-therapy","lymphoma-tx-maintenance","flipi"],"trials":["prima-follicular"],"people":["gilles-salles"],"bottlenecks":["b-toxicity-qol"],"keyPapers":[],"journals":["lancet"],"dependsOn":[],"notes":[],"journal":"Lancet","year":2011,"doi":"10.1016/S0140-6736(10)62175-7","pmid":"21176949","authors":"Salles G, Seymour JF, Offner F, et al.","paperType":"rct","findings":["Three-year progression-free survival was 74.9 per cent (95 per cent confidence interval 70.9 to 78.9) with two years of rituximab maintenance against 57.6 per cent (53.2 to 62.0) with observation.","130 patients progressed in the maintenance group against 218 in the observation group (hazard ratio 0.55, 0.44 to 0.68).","1,217 patients received induction and 1,019 responders were randomised.","Induction regimen was chosen by the centre rather than randomised, reflecting routine practice across 25 countries."],"whatItMeans":"The trial that made two years of rituximab maintenance a routine offer after first-line immunochemotherapy for follicular lymphoma with a high tumour burden.","caveats":["Open-label with observation rather than placebo as the comparator, so progression assessment was not blinded.","Induction was not randomised, so the arms differ in induction mix only by chance.","At 36 months the trial could not address overall survival; the 2019 report did, and found no difference."],"changedPractice":true,"participants":1018},"route":"/key-papers/paper-prima-rituximab-maintenance-follicular-lancet-2011/","neighbours":{"paper":[{"id":"paper-prima-final-rituximab-maintenance-follicular-jco-2019","kind":"paper","name":"Sustained progression-free survival benefit of rituximab maintenance in patients with follicular lymphoma: long-term results of the PRIMA study","route":"/key-papers/paper-prima-final-rituximab-maintenance-follicular-jco-2019/"}],"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"cancer":[{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"}],"section":[{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"}],"target":[{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"drug":[{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"}],"company":[{"id":"lysa","kind":"company","name":"LYSA (The Lymphoma Study Association)","route":"/companies/lysa/"}],"term":[{"id":"flipi","kind":"term","name":"FLIPI, FLIPI2 and POD24 (follicular lymphoma risk)","route":"/terms/flipi/"},{"id":"lymphoma-tx-maintenance","kind":"term","name":"Maintenance and consolidation in lymphoma: where it works and where it does not","route":"/terms/lymphoma-tx-maintenance/"},{"id":"maintenance-therapy","kind":"term","name":"Maintenance therapy","route":"/terms/maintenance-therapy/"}],"trial":[{"id":"prima-follicular","kind":"trial","name":"PRIMA","route":"/trials/prima-follicular/"}],"person":[{"id":"gilles-salles","kind":"person","name":"Gilles Salles","route":"/people/gilles-salles/"}],"bottleneck":[{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"}],"journal":[{"id":"lancet","kind":"journal","name":"The Lancet","route":"/journals/lancet/"}]}}