Matches in SemOpenAlex for { <https://semopenalex.org/work/W2304617849> ?p ?o ?g. }
- W2304617849 endingPage "509" @default.
- W2304617849 startingPage "509" @default.
- W2304617849 abstract "Abstract The intergroup PRIMA Phase III study was designed to investigate the potential benefit of 2-years of rituximab maintenance in patients with follicular lymphoma (FL) responding to one of three non-randomised first line immunochemotherapy treatments. The results of the final analysis with 36 months follow-up (Salles et al., Lancet 2011) demonstrated a significant reduction of the risk of progression or death with a hazard ratio (HR) of 0.55 in favour of patients randomized to rituximab maintenance. We present here the updated results with 3 additional years of follow-up. From December 2004 until April 2007, 1217 patients were enrolled from 223 centres and complete data were available for 1193 patients who had the following pre-induction treatment characteristics: median age 56 years [range 22–87]; 52% male; 90% Ann Arbor stage III-IV; 33% B symptoms; 56% bone marrow involvement; 4% ECOG performance status >1; 34% elevated LDH; 32% β2-microglobulin >3mg/L; FLIPI score 0-1 (21%), FLIPI 2 (36%), FLIPI 3-5 (43%). Most patients (75%) received R-CHOP induction (22% R-CVP, 3% R-FCM). Patients responding to induction therapy were stratified based on their immunochemotherapy regimen and response [CR/CRu versus PR] and randomized to observation or rituximab maintenance, 1 infusion (375 mg/m2) every 8 weeks for 2 years. A total of 1018 randomised patients were analyzed according to the ITT principle (513 observation / 505 rituximab maintenance). All initial pre-treatment characteristics were well balanced between arms and the response status at time of randomization was CR=39%; CRu=32% and PR=28% (others 1%). With a median follow-up of 73 months from randomization, 6-year progression free survival estimate was 42.7% (95% CI 38 – 46.9%) in the observation arm (284 events, median=48 months) and 59.2% (95% CI 54.7 – 63.7%) in the rituximab maintenance arm (194 events, median not reached), respectively (stratified Log-Rank, P<. 0001; HR = 0.58 ; 95% CI 0.48 - 0.69). In pre-planned analyses of patients subgroups categorized by age, sex, FLIPI score category, induction chemotherapy and response to induction, the effect of rituximab maintenance was examined and found to be consistent among these different subgroups. In a Cox regression multivariate analysis, rituximab maintenance (HR=0.57; P<.0001) as well as older age (HR=0.79; P=.015), female sex (HR=0.72; P=.0003) and low or intermediate FLIPI groups (HR=0.67; P<.0001) were all significant variables associated with superior progression free survival. A significant reduction in the risk of starting a new anti-lymphoma treatment (HR=0.63, 95% CI 0.52 - 0.76) or starting a new chemotherapy (HR=0.70, 95% CI 0.57 - 0.86) were also observed for rituximab maintenance. The rate of histological transformation did not appear to differ between the 2 treatment arms: in the observation arm, transformation was documented in 24 patients (114 cases with morphological documentation out of 278 progressions) versus 16 patients in the rituximab maintenance arm (80 out of 186) respectively. Overall response rate to second-line therapy was reported by investigators to be 180/227 (79%) in patients from the observation arm (CR/CRu=61%; PR=19%) versus 109/144 (76%) in patients from the rituximab maintenance arm (CR/CRu =51%; PR=22%) (P=NS). At the time of the data cut-off, overall survival (OS) remains favourable in both study arms: 58 patients (11.3%) have died in the observation arm (6-years OS estimate 88.7%) compared to 59 patients (11.7%) in the rituximab maintenance arm (6-year OS estimate 87,4%). Main causes documented for death in the observation and rituximab maintenance arm respectively were lymphoma (28 ; 28), other malignancy (19 ; 5) and infections (4 ; 7). No new significant safety data were captured with this additional follow-up period. In conclusion, with 3 additional years of follow-up, these data demonstrate a sustained and persistent benefit of 2 years of rituximab maintenance therapy after immunochemotherapy, resulting in improved progression free survival. No additional or unexpected long term toxicities were observed and second line therapy efficacy results did not significantly differ between the 2 study arms. Overall survival appears very favourable for these randomized patients. Disclosures: Salles: Roche: Consultancy, Honoraria, Research Funding. Seymour:Roche: Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau, Travel support Other; Genetech: Honoraria, Membership on an entity’s Board of Directors or advisory committees. Feugier:Roche: Honoraria, Membership on an entity’s Board of Directors or advisory committees. Offner:Lilly: Membership on an entity’s Board of Directors or advisory committees. Lopez-Guillermo:Roche: Membership on an entity’s Board of Directors or advisory committees. Belada:Roche: Consultancy. Catalano:Roche: Membership on an entity’s Board of Directors or advisory committees. Haioun:Roche: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding. Simpson:Janssen Research & Development: Honoraria. Leppa:Roche: Consultancy, Honoraria, Research Funding, Travel support Other. Soubeyran:Roche: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding. Hagenbeek:Takeda/Millennium: Consultancy. Casasnovas:ROCHE: Consultancy, Honoraria, Research Funding. Coiffier:Millennium Pharmaceuticals : Consultancy. Tilly:Roche: Honoraria; Celgene: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity’s Board of Directors or advisory committees; Pfizer: Honoraria; Janssen: Honoraria; Amgen: Research Funding." @default.
- W2304617849 created "2016-06-24" @default.
- W2304617849 creator A5003078312 @default.
- W2304617849 creator A5003105021 @default.
- W2304617849 creator A5006889768 @default.
- W2304617849 creator A5010189385 @default.
- W2304617849 creator A5010733763 @default.
- W2304617849 creator A5017140592 @default.
- W2304617849 creator A5028150737 @default.
- W2304617849 creator A5031041032 @default.
- W2304617849 creator A5033149886 @default.
- W2304617849 creator A5038243788 @default.
- W2304617849 creator A5043162057 @default.
- W2304617849 creator A5044335760 @default.
- W2304617849 creator A5044625155 @default.
- W2304617849 creator A5051138260 @default.
- W2304617849 creator A5051888634 @default.
- W2304617849 creator A5054416214 @default.
- W2304617849 creator A5056514957 @default.
- W2304617849 creator A5061223719 @default.
- W2304617849 creator A5064830159 @default.
- W2304617849 creator A5064831033 @default.
- W2304617849 creator A5065987951 @default.
- W2304617849 creator A5067560032 @default.
- W2304617849 creator A5068111941 @default.
- W2304617849 creator A5072246038 @default.
- W2304617849 creator A5074815016 @default.
- W2304617849 creator A5079071165 @default.
- W2304617849 creator A5081326206 @default.
- W2304617849 creator A5086354986 @default.
- W2304617849 creator A5090326578 @default.
- W2304617849 date "2013-11-15" @default.
- W2304617849 modified "2023-10-08" @default.
- W2304617849 title "Updated 6 Year Follow-Up Of The PRIMA Study Confirms The Benefit Of 2-Year Rituximab Maintenance In Follicular Lymphoma Patients Responding To Frontline Immunochemotherapy" @default.
- W2304617849 doi "https://doi.org/10.1182/blood.v122.21.509.509" @default.
- W2304617849 hasPublicationYear "2013" @default.
- W2304617849 type Work @default.
- W2304617849 sameAs 2304617849 @default.
- W2304617849 citedByCount "62" @default.
- W2304617849 countsByYear W23046178492014 @default.
- W2304617849 countsByYear W23046178492015 @default.
- W2304617849 countsByYear W23046178492016 @default.
- W2304617849 countsByYear W23046178492017 @default.
- W2304617849 countsByYear W23046178492018 @default.
- W2304617849 countsByYear W23046178492019 @default.
- W2304617849 countsByYear W23046178492020 @default.
- W2304617849 countsByYear W23046178492021 @default.
- W2304617849 countsByYear W23046178492023 @default.
- W2304617849 crossrefType "journal-article" @default.
- W2304617849 hasAuthorship W2304617849A5003078312 @default.
- W2304617849 hasAuthorship W2304617849A5003105021 @default.
- W2304617849 hasAuthorship W2304617849A5006889768 @default.
- W2304617849 hasAuthorship W2304617849A5010189385 @default.
- W2304617849 hasAuthorship W2304617849A5010733763 @default.
- W2304617849 hasAuthorship W2304617849A5017140592 @default.
- W2304617849 hasAuthorship W2304617849A5028150737 @default.
- W2304617849 hasAuthorship W2304617849A5031041032 @default.
- W2304617849 hasAuthorship W2304617849A5033149886 @default.
- W2304617849 hasAuthorship W2304617849A5038243788 @default.
- W2304617849 hasAuthorship W2304617849A5043162057 @default.
- W2304617849 hasAuthorship W2304617849A5044335760 @default.
- W2304617849 hasAuthorship W2304617849A5044625155 @default.
- W2304617849 hasAuthorship W2304617849A5051138260 @default.
- W2304617849 hasAuthorship W2304617849A5051888634 @default.
- W2304617849 hasAuthorship W2304617849A5054416214 @default.
- W2304617849 hasAuthorship W2304617849A5056514957 @default.
- W2304617849 hasAuthorship W2304617849A5061223719 @default.
- W2304617849 hasAuthorship W2304617849A5064830159 @default.
- W2304617849 hasAuthorship W2304617849A5064831033 @default.
- W2304617849 hasAuthorship W2304617849A5065987951 @default.
- W2304617849 hasAuthorship W2304617849A5067560032 @default.
- W2304617849 hasAuthorship W2304617849A5068111941 @default.
- W2304617849 hasAuthorship W2304617849A5072246038 @default.
- W2304617849 hasAuthorship W2304617849A5074815016 @default.
- W2304617849 hasAuthorship W2304617849A5079071165 @default.
- W2304617849 hasAuthorship W2304617849A5081326206 @default.
- W2304617849 hasAuthorship W2304617849A5086354986 @default.
- W2304617849 hasAuthorship W2304617849A5090326578 @default.
- W2304617849 hasConcept C126322002 @default.
- W2304617849 hasConcept C141071460 @default.
- W2304617849 hasConcept C168563851 @default.
- W2304617849 hasConcept C204243189 @default.
- W2304617849 hasConcept C207103383 @default.
- W2304617849 hasConcept C2776694085 @default.
- W2304617849 hasConcept C2777058707 @default.
- W2304617849 hasConcept C2778283404 @default.
- W2304617849 hasConcept C2779338263 @default.
- W2304617849 hasConcept C2780653079 @default.
- W2304617849 hasConcept C2781413609 @default.
- W2304617849 hasConcept C44249647 @default.
- W2304617849 hasConcept C71924100 @default.
- W2304617849 hasConcept C90924648 @default.
- W2304617849 hasConceptScore W2304617849C126322002 @default.
- W2304617849 hasConceptScore W2304617849C141071460 @default.
- W2304617849 hasConceptScore W2304617849C168563851 @default.
- W2304617849 hasConceptScore W2304617849C204243189 @default.
- W2304617849 hasConceptScore W2304617849C207103383 @default.
- W2304617849 hasConceptScore W2304617849C2776694085 @default.