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

Steven Le Gouill 1, 2, * Hervé Ghesquieres 3 Lucie Obéric 4 Franck Morschhauser 5 Herve Tilly 6 Vincent Ribrag 7, 8 Thierry Lamy 9, 10 Catherine Thieblemont 11 Herve Gerard Maisonneuve 12 Remy Gressin 13 Krimo Bouabdallah 14 Corinne Haioun 15 Gandhi Damaj 16 Luc-Matthieu Fornecker 17 Reda Bouabdallah 18 Pierre Feugier 19, 20 David Sibon 21 Guillaume Cartron 22, 23 Christophe Bonnet 24 Marc André 25 Loic Chartier 26 Philippe Ruminy 6 F Kraeber-Bodere 1 C Bodet-Milin 1 Alina Berriolo-Riedinger 27 Josette Briere 28 Jean-Philippe Jais 29 Thierry Molina 21 Emmanuel Itti 15 Olivier Casasnovas 30
* Corresponding author
2 CRCINA-ÉQUIPE 10 - Regulation of Bcl2 and p53 Networks in Multiple Myeloma and Mantle Cell Lymphoma
CRCINA - Centre de Recherche en Cancérologie et Immunologie Nantes-Angers
Abstract : Rituximab plus polychemotherapy is standard of care in diffuse large B-cell lymphoma (DLBCL). GAINED trial compares obinutuzumab to rituximab. GAINED (NCT01659099) is an open-label, randomized phase 3 trial. Transplant-eligible patients (18-60yrs) with untreated aged-adjusted international prognostic index (aaIPI) ≥1 DLBCL were randomized (1:1) between obinutuzumab or rituximab. Patients were stratified by aaIPI (1; 2-3) and chemotherapy regimen (ACVBP; CHOP). Consolidation treatment was determined according to response assessed by centrally reviewed interim semi-quantitative PET. Responders after cycle 2 and 4 (PET2-/PET4-) received planned immuno-chemotherapy consolidation. Responders only after cycle 4 (PET2+/4-) received high-dose methotrexate plus transplantation. The primary objective was an 8% improvement (HR=0.73; 80% power; alpha risk 2.5%; one-sided) in 2-year event-free survival (EFS) in the obinutuzumab arm. Events included death, progression, PET 2 or 4 positivity, modification of planned treatment. From September 20, 2012, 670 patients were enrolled (obinutuzumab n=336; rituximab n=334). 383 (57.2%) were aaIPI 2-3, 339 (50.6%) received CHOP and 324 (48.4%) received ACVBP. Median follow-up was 38.7 months. The 2-year EFS were similar in obinutuzumab and rituximab groups (59.8% vs 56.6%; p=0.123; HR=0.88). The 2-year PFS in the whole cohort was 83.1% (95%CI 80-85.8). PET2-/4- and PET2+/4- had similar 2-year PFS and 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 untreated aaIPI≥1 DLBCL transplant-eligible patients.
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Submitted on : Friday, February 5, 2021 - 12:18:15 PM
Last modification on : Tuesday, September 21, 2021 - 1:49:35 PM
Long-term archiving on: : Friday, May 7, 2021 - 8:26:50 AM

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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, American Society of Hematology, 2020, ⟨10.1182/blood.2020008750⟩. ⟨hal-03122586⟩

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