Evidence map›Paper›PMID 31339826›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study.

Emmanuel Bachy, John F Seymour, Pierre Feugier, Fritz Offner, Armando López-Guillermo, David Belada, Luc Xerri, John V Catalano, Pauline Brice, François Lemonnier and 21 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00140582 (Advanced Follicular Lymphoma Evaluating the Benefit of Maintenance Therapy With Rituximab), which is not on this map. Cited by 130 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
130citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00140582 phase3completednot on this map

Advanced Follicular Lymphoma Evaluating the Benefit of Maintenance Therapy With Rituximab (MabThera®) After Induction of Response With Chemotherapy Plus Rituximab in Comparison With no Maintenance Therapy

TypeinterventionalSponsorLymphoma Study AssociationRan2004 to 2016Enrolled1,217ConditionsFollicular LymphomaArmsRituximab
3 · Its place in the literature

Who cites it

130 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  4. A genetic profiling guideline to support diagnosis and clinical management of lymphomas.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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70 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors.

Emmanuel BachyHospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France.
John F SeymourRoyal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia.
Pierre FeugierCentre Hospitalier Régional Universitaire de Nancy, Université de Lorraine, INSERM 1256, Nancy, France.
Fritz OffnerGhent University, Ghent, Belgium.
Armando López-GuillermoHospital Clinic, Barcelona, Spain.
David BeladaCharles University, Hradec Králové, Czech Republic.
Luc XerriInstitut Paoli-Calmettes, Aix-Marseille Université, Marseille, France.
John V CatalanoFrankston Hospital and Monash University, Frankston, Victoria, Australia.
Pauline BriceHôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.
François LemonnierHôpitaux Universitaires Henri Mondor, Université Paris-Est Créteil, INSERM U955, Créteil, France.
Alejandro MartinHospital Universitario de Salamanca-Institute for Biomedical Research of Salamanca, Centro de Investigación Biomédica en Red de Cáncer, Salamanca, Spain.
Olivier CasasnovasDepartment of Haematology and INSERM 1231, University Hospital F. Mitterrand, Dijon, France.
Lars M PedersenHerlev University Hospital, Copenhagen, Denmark.
Véronique DorvauxHôpital de Mercy Centre Hospitalier Régional Metz-Thionville, Metz, France.
David SimpsonNorth Shore Hospital, Auckland, New Zealand.
Sirpa LeppaHelsinki University Hospital, University of Helsinki, Helsinki, Finland.
Jean GabarreHôpital Pitié-Salpêtrière, Paris, France.
Maria G da SilvaPortuguese Institute of Oncology, Lisbon, Portugal.
Sylvie GlaisnerInstitut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.
Loic YsebaertInstitut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.
Anne VekhoffSaint Antoine Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
Tanin IntragumtornchaiChulalongkorn University, Bangkok, Thailand.
Steven Le GouillCentre Hospitalier Universitaire de Nantes, Centre de Recherche en Cancérologie et Immunologie Nantes Angers, INSERM, Université de Nantes, Nantes, France.
Andrew ListerQueen Mary University of London, London, United Kingdom.
Jane A EstellConcord Hospital, Concord, University of Sydney, New South Wales, Australia.
Gustavo MiloneFundaleu, Buenos Aires, Argentina.
Anne SonetUCL, Mont-Godinne, Yvoir, Belgium.
Jonathan FarhiCentre Hospitalier Universitaire d'Angers, Angers, France.
Harald ZeunerF Hoffman-La Roche, Basel, Switzerland.
Hervé TillyCentre Henri-Becquerel, Rouen, France.
Gilles SallesHospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe PRIMA study (ClinicalTrials.gov identifier: NCT00140582) established that 2 years of rituximab maintenance after first-line immunochemotherapy significantly improved progression-free survival (PFS) in patients with follicular lymphoma compared with observation. Here, we report the final PFS and overall survival (OS) results from the PRIMA study after 9 years of follow-up and provide a final overview of safety.

methodsPatients (> 18 years of age) with previously untreated high-tumor-burden follicular lymphoma were nonrandomly assigned to receive one of three immunochemotherapy induction regimens. Responding patients were randomly assigned (stratified by induction regimen, response to induction treatment, treatment center, and geographic region) 1:1 to receive 2 years of rituximab maintenance (375 mg/m

resultsIn total, 1,018 patients completed induction treatment and were randomly assigned to rituximab maintenance (n = 505) or observation (n = 513). Consent for the extended follow-up was provided by 607 patients (59.6%) of 1,018 (rituximab maintenance, n = 309; observation, n = 298). After data cutoff, median PFS was 10.5 years in the rituximab maintenance arm compared with 4.1 years in the observation arm (hazard ratio, 0.61; 95% CI, 0.52 to 0.73;

conclusionRituximab maintenance after induction immunochemotherapy provides a significant long-term PFS, but not OS, benefit over observation.

Indexed as

Watchful WaitingAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalDisease ProgressionFemaleHumansLymphoma, FollicularMaleMiddle AgedProgression-Free SurvivalRituximabTime FactorsYoung AdultAntineoplastic Agents, ImmunologicalRituximab

Identifiers

PMID31339826
PMCPMC6823890

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.