Evidence map›Paper›PMID 38385243›Full record

Trial reportHaematologica2024

IELSG38: phase II trial of front-line chlorambucil plus subcutaneous rituximab induction and maintenance in mucosa-associated lymphoid tissue lymphoma.

Anastasios Stathis, Maria Cristina Pirosa, Lorella Orsucci, Pierre Feugier, Monica Tani, Hervé Ghesquières, Gerardo Musuraca, Francesca Gaia Rossi, Francesco Merli, Romain Guièze and 37 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Haematologica, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.3field-weighted citation impact, top 23% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

47 authors at 20 institutions in 3 countries.

Anastasios StathisOncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Università della Svizzera Italiana, Faculty of Biomedical Sciences, Lugano. anastasios.stathis@eoc.ch.
Maria Cristina PirosaOncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Institute of Oncology Research, Bellinzona.
Lorella OrsucciS.C. Ematologia, AOU Città della Salute e della Scienza di Torino, Turin.
Pierre FeugierDepartment of Clinical Hematology, Nancy University Hospital, INSERM 1256, Nancy.
Monica TaniU.O. Ematologia, Dipartimento Oncologia e Ematologia, Ospedale Santa Maria delle Croci, Ravenna.
Hervé GhesquièresHematology Department, Hospices Civils de Lyon, CHU Lyon-Sud, Pierre-Bénite.
Gerardo MusuracaHematology Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola.
Francesca Gaia RossiHematology-BMT Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milano.
Francesco MerliAUSL-IRCCS of Reggio Emilia, Reggio Emilia.
Romain GuièzeService d'Hématologie Clinique et de Thérapie Cellulaire, CHU Estaing, Clermont- Ferrand.
Emmanuel GyanHématologie et thérapie cellulaire, CIC Inserm U1415, Centre Hospitalier Universitaire de Tours, Tours.
Guido GiniHematology, Department of Clinical and Molecular Sciences, Marche Polytechnic University, Ancona.
Dario MarinoOncology 1 Unit, Istituto Oncologico Veneto IOV-IRCCS, Padova.
Remy GressinInstitute for Advanced Biosciences, INSERM U1209/CNRS UMR 5309/Grenoble Alpes University, Grenoble.
Franck MorschhauserUniversité de Lille, CHU Lille, Department of Hematology, Lille.
Federica CavalloDivision of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino/AOU Città della Salute e della Scienza di Torino, Turin.
Francesca PalombiHematology and Stem Cell Transplant Unit, IRCCS. National Cancer Institute, Istituto Regina Elena, Rome Italy.
Annarita ConconiDivision of Hematology, Ospedale degli Infermi, Biella.
Benoît TessoulinHématologie Clinique, CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes.
Hervé TillyDepartment of Hematology and U1245, Centre Henri Becquerel, Rouen.
Manuela ZanniHematology Unit, Antonio e Biagio e Cesare Arrigo Hospital, Alessandria.
Maria Giuseppina CabrasOspedale Oncologico, Ematologia e CTMO, Cagliari.
Enrico CapochianiHematology Unit, Azienda USL Toscana NordOvest, Center for Translational Medicine, Livorno.
Catello CalifanoHematology Unit, P.O. A. Tortora, Pagani.
Melania CelliHematology Unit, Ospedale degli Infermi, Rimini.
Alessandro PulsoniDepartment of Translational and Precision Medicine, Sapienza University, Rome.
Francesco AngrilliUnità Operativa Semplice Dipartimentale Centro Diagnosi e Terapia Linfomi, Presidio Ospedaliero, Pescara.
Ubaldo OcchiniUnità Operativa di Ematologia, Ospedale San Donato, AUSL Toscana Sud-Est, Arezzo.
René-Olivier CasasnovasDepartment of Hematology, University Hospital F Mitterrand and INSERM 1231, Dijon.
Guillaume CartronHématologie Clinique, CHU Montpellier, UMR 5535 Montpellier.
Liliana DevizziHematology Unit, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan.
Corinne HaiounLymphoid Malignancies Unit, Hôpital Henri Mondor, AP-HP, Créteil.
Anna Marina LiberatiSC Oncoematologia, Azienda Ospedaliera Santa Maria, Università degli studi di Perugia, Terni.
Roch HouotDepartment of Clinical Hematology, University Hospital of Rennes, Rennes.
Michele MerliDivision of Hematology, University Hospital Ospedale di Circolo e Fondazione Macchi ASST Sette Laghi, University of Insubria, Varese.
Giuseppe PietrantuonoHematology Unit, Centro di Riferimento Oncologico della Basilicata IRCCS Rionero in Vulture.
Francesca ReHematology and BMT Center, Azienda Ospedaliera Universitaria, Parma.
Michele SpinaDivision of Medical Oncology, Centro di Riferimento Oncologico IRCCS, Aviano.
Francesco LandiOncology Institute of Southern Switzerland, EOC, Bellinzona.
Franco CavalliInstitute of Oncology Research, Bellinzona.
Francesco BertoniOncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Università della Svizzera Italiana, Faculty of Biomedical Sciences, Lugano, Switzerland; Institute of Oncology Research, Bellinzona.
Davide RossiOncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Università della Svizzera Italiana, Faculty of Biomedical Sciences, Lugano, Switzerland; Institute of Oncology Research, Bellinzona.
Nicoletta IelminiInstitute of Oncology Research, Bellinzona.
Elena BorgoFIL, Fondazione Italiana Linfomi ONLUS, Alessandria.
Stefano LuminariAUSL-IRCCS of Reggio Emilia, Reggio Emilia, Italy; CHIMOMO Department, University of Modena and Reggio Emilia, Reggio Emilia.
Emanuele ZuccaOncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Università della Svizzera Italiana, Faculty of Biomedical Sciences, Lugano, Switzerland; Institute of Oncology Research, Bellinzona, Switzerland; Medical Oncology, University Hospital and University of Bern.
Catherine ThieblemontAPHP - Service d'Hématologie-Oncologie, Hôpital Saint Louis, Université de Paris - Diderot, Paris.
Institute of Oncology Research · CHInserm · FROspedale degli Infermi · ITAzienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo · ITAzienda Sanitaria Unità Locale di Reggio Emilia · ITAzienda Usl Toscana Centro · ITCentre Henri BecquerelCentre Hospitalier Universitaire de Clermont-Ferrand · FRCentre Hospitalier Universitaire de Montpellier · FRCentre Hospitalier Universitaire de Rennes · FRCentre Hospitalier Universitaire de Tours · FRCentre National de la Recherche Scientifique · FRCentro di Riferimento Oncologico · ITCentro di Riferimento Oncologico della Basilicata · ITDélégation Paris 7 · FRFondazione Intergruppo Italiano Linfomi Onlus · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITHôpitaux Universitaires Henri-Mondor · FRHospices Civils de Lyon · FRIstituti di Ricovero e Cura a Carattere Scientifico · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The IELSG38 trial was conducted to investigate the effects of subcutaneous (SC) rituximab on the complete remission (CR) rate and the benefits of SC rituximab maintenance in patients with extranodal marginal zone lymphoma (MZL) who received front-line treatment with chlorambucil plus rituximab. Study treatment was an induction phase with oral chlorambucil 6 mg/m2/day on weeks 1-6, 9-10, 13-14, 17-18, and 21-22, and intravenous rituximab 375 mg/m2 on day 1 of weeks 1-4, and 1,400 mg SC on weeks 9, 13, 17, and 21. Then, a maintenance phase followed with rituximab administered at 1,400 mg SC every two months for two years. Of the 112 patients enrolled, 109 were evaluated for efficacy. The CR rates increased from 52% at the end of the induction phase to 70% upon completion of the maintenance phase. With a median follow-up of 5.8 years, the 5-year event-free, progression-free, and overall survival rates were 87% (95% CI: 78-92), 84% (95% CI: 75-89), and 93% (95% CI: 86-96), respectively. The most common grade ≥3 toxicities were neutropenia (33%) and lymphocytopenia (16%). Six patients experienced treatment-related serious adverse events, including fever of unknown origin, sepsis, pneumonia, respiratory failure, severe cerebellar ataxia, and fatal acute myeloid leukemia. The trial showed that SC rituximab did not improve the CR rate at the conclusion of the induction phase, which was the main endpoint. Nevertheless, SC rituximab maintenance might have facilitated long-term disease control, potentially contributing to enhanced event-free and progression-free survival.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsChlorambucilLymphoma, B-Cell, Marginal ZoneRituximabAdultAgedAged, 80 and overFemaleHumansInjections, SubcutaneousMaintenance ChemotherapyMaleMiddle AgedRemission InductionTreatment OutcomeChlorambucilRituximab

Identifiers

PMID38385243
PMCPMC11290511
OpenAlexW4392087892

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.