Obinutuzumab versus Rituximab in young patients with advanced DLBCL, a PET-guided and randomized phase 3 study by LYSA - CNRS - Centre national de la recherche scientifique Accéder directement au contenu
Article Dans Une Revue Blood Année : 2021

Obinutuzumab versus Rituximab in young patients with advanced DLBCL, a PET-guided and randomized phase 3 study by LYSA

1 CHU Nantes - Centre Hospitalier Universitaire de Nantes
2 CRCINA-ÉQUIPE 10 - Regulation of Bcl2 and p53 Networks in Multiple Myeloma and Mantle Cell Lymphoma
3 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]
4 IUCT Oncopole - UMR 1037 - Institut Universitaire du Cancer de Toulouse - Oncopole
5 GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365
6 CLCC Henri Becquerel - Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen
7 IGR - Institut Gustave Roussy
8 AMMICa - Analyse moléculaire, modélisation et imagerie de la maladie cancéreuse
9 MICMAC - Microenvironment, Cell Differentiation, Immunology and Cancer
10 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
11 Service d'Hémato-oncologie [CHU Saint-Louis]
12 CHD Vendée - Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
13 Hôpital Michallon
14 CHU Pessac
15 CHI Créteil
16 IHBN - Institut d'Hématologie de Basse-Normandie
17 HUS - Les Hôpitaux Universitaires de Strasbourg
18 IPC - Institut Paoli-Calmettes
19 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
20 NGERE - Nutrition-Génétique et Exposition aux Risques Environnementaux
21 Hôpital Necker - Enfants Malades [AP-HP]
22 IGMM - Institut de Génétique Moléculaire de Montpellier
23 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
24 CHU-Liège - Centre Hospitalier Universitaire de Liège
25 CHU UCL Namur
26 LYSARC - The Lymphoma Academic Research Organisation [Lyon]
27 UNICANCER/CRLCC-CGFL - Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon]
28 AP-HP - Hopital Saint-Louis [AP-HP]
29 UPD5 - Université Paris Descartes - Paris 5
30 CHU Dijon
Remy Gressin
  • Fonction : Auteur
Krimo Bouabdallah
  • Fonction : Auteur
Corinne Haioun
  • Fonction : Auteur
Marc André
  • Fonction : Auteur
Emmanuel Itti
  • Fonction : Auteur
Olivier Casasnovas
  • Fonction : Auteur

Résumé

Rituximab plus polychemotherapy is the standard of care in diffuse large B-cell lymphoma (DLBCL). GAINED, a randomized phase 3 trial, compared obinutuzumab to rituximab. Transplant-eligible patients (18-60 years) with an untreated age-adjusted International Prognostic Index (aaIPI) score ≥1 DLBCL were randomized (1:1) between obinutuzumab or rituximab and stratified by aaIPI (1; 2-3) and chemotherapy regimen (doxorubicin, cyclophosphamide, prednisone plus vindesine, bleomycin [ACVBP] or vincristine [CHOP]). Consolidation treatment was determined according to response to interim positron emission tomography (PET). Responders after cycle 2 and 4 (PET2-/PET4-) received immunochemotherapy. Responders after only cycle 4 (PET2+/4-) received transplantation. The primary objective was an 8% improvement (hazard ratio [HR] = 0.73; 80% power; α risk, 2.5%; 1-sided) in 2-year event-free survival (EFS) in the obinutuzumab arm. From September 2012, 670 patients were enrolled (obinutuzumab, n = 336; rituximab, n = 334). A total of 383 (57.2%) were aaIPI 2-3, 339 (50.6%) received CHOP. Median follow-up was 38.7 months. The 2-year EFS was similar in both groups (59.8% vs 56.6%; P = .123; HR = 0.88). The 2-year PFS in the whole cohort was 83.1% (95% confidence interval, 80% to 85.8%). PET2-/4- and PET2+/4- had similar 2-year progression-free survival (PFS) and overall survival (OS): 89.9% vs 83.9% and 94.8% vs 92.8%. The 2-year PFS and OS for PET4+ patients were 62% and 83.1%. Grade 3-5 infections were more frequent in the obinutuzumab arm (21% vs 12%). Obinutuzumab is not superior to rituximab in aaIPI ≥1 DLBCL transplant-eligible patients. This trial was registered at www.clinicaltrials.gov as #NCT01659099.
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Dates et versions

hal-03122586 , version 1 (05-02-2021)

Identifiants

Citer

Steven Le Gouill, Hervé Ghesquieres, Lucie Obéric, Franck Morschhauser, Herve Tilly, et al.. Obinutuzumab versus Rituximab in young patients with advanced DLBCL, a PET-guided and randomized phase 3 study by LYSA. Blood, 2021, 137 (17), pp.2307-2320. ⟨10.1182/blood.2020008750⟩. ⟨hal-03122586⟩
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