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Phase III study of ACVBP versus ACVBP plus rituximab for patients with localized low-risk diffuse large B-cell lymphoma (LNH03-1B)

Ketterer, N. ; Coiffier, B. ; Thieblemont, C. ; Fermé, C. ; Brière, J. ; Casasnovas, O. ; Bologna, S. ; Christian, B. ; Connerotte, T. ; Récher, C. ; Bordessoule, D. ; Fruchart, C. ; Delarue, R. ; Bonnet, C. ; Morschhauser, F. ; Anglaret, B. ; Soussain, C. ; Fabiani, B. ; Tilly, H. ; Haioun, C.

In: Annals of Oncology, 2013, vol. 24, no. 4, p. 1032-1037

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    Titre
    • Phase III study of ACVBP versus ACVBP plus rituximab for patients with localized low-risk diffuse large B-cell lymphoma (LNH03-1B)
    Auteur
    • Ketterer, N.. Department of Oncology, University Hospital, Lausanne, Switzerland
    • Coiffier, B.. Department of Hematology, Lyon Sud University Hospital, Pierre-Bénite
    • Thieblemont, C.. Department of Hematology, St Louis University Hospital, Paris
    • Fermé, C.. Department of Hematology, Gustave Roussy Institute, Villejuif
    • Brière, J.. Department of Pathology, St Louis University Hospital, Paris
    • Casasnovas, O.. Department of Hematology, University Hospital, Dijon
    • Bologna, S.. Department of Hematology, University Hospital, Nancy-Brabois, Vandoeuvre
    • Christian, B.. Department of Hematology, Bon Secours Hospital, Metz, France
    • Connerotte, T.. Department of Hematology, St Luc University Hospital, Bruxelles, Belgium
    • Récher, C.. Department of Hematology, University Hospital, Toulouse
    • Bordessoule, D.. Department of Hematology, University Hospital Limoges, Limoges
    • Fruchart, C.. Department of Hematology, François Baclesse Center, Caen
    • Delarue, R.. Department of Hematology, Necker University Hospital, Paris, France
    • Bonnet, C.. Department of Hematology, Sart Tilman University Hospital, Liège, Belgium
    • Morschhauser, F.. Department of Hematology, Claude Huriez University Hospital, Lille
    • Anglaret, B.. Department of Hematology, University Hospital, Valence
    • Soussain, C.. Department of Hematology, René Huguenin Hospital, Saint Cloud
    • Fabiani, B.. Department of Pathology, Saint-Antoine Hospital, Paris
    • Tilly, H.. Department of Hematology, Henri Becquerel Center, Rouen
    • Haioun, C.. Department of Hematology, Henri Mondor University Hospital, Créteil, France
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Annals of Oncology, 2013, vol. 24, no. 4, p. 1032-1037. Oxford University Press
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:304465
    Summary
    Background The superiority of a chemotherapy with doxorubicin, cyclophosphamide, vindesine, bleomycin and prednisone (ACVBP) in comparison with cyclophosphamide, doxorubicin, vincristin and prednisone plus radiotherapy for young patients with localized diffuse large B-cell lymphoma (DLBCL) was previously demonstrated. We report the results of a trial which evaluates the role of rituximab combined with ACVBP (R-ACVBP) in these patients. Patients and methods Untreated patients younger than 66 years with stage I or II DLBCL and no adverse prognostic factors of the age-adjusted International Prognostic Index were randomly assigned to receive three cycles of ACVBP plus sequential consolidation with or without the addition of four infusions of rituximab. Results A total of 223 patients were randomly allocated to the study, 110 in the R-ACVBP group and 113 in the ACVBP group. After a median follow-up of 43 months, our 3-year estimate of event-free survival was 93% in the R-ACVBP group and 82% in the ACVBP group (P = 0.0487). Three-year estimate of progression-free survival was increased in the R-ACVBP group (95% versus 83%, P = 0.0205). Overall survival did not differ between the two groups with a 3-year estimates of 98% and 97%, respectively (P = 0.686). Conclusion In young patients with low-risk localized DLBCL, rituximab combined with three cycles of ACVBP plus consolidation is significantly superior to ACVBP plus consolidation alone